Regulatory Open Forum

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

I should have added that there are only three states for a given device.

It meets the requirements under the MDD/AIMD

It is an EU-MDR Article 120 device (some MDD/AIMD and some MDR)

It is an EU-MDR device

There are also three states for an NB

Designated under the MDD/AIMD and supports Article 120

Designated under the MDD/AIMD and does not support Article 120

Designated under the MDR

It would seem that there are 3 × 3 = 9 states. However, there are Class I devices that don't need an NB under MDD and Class I devices that don't need an NB under MDR. The set of Class I devices is not the same in both cases.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

I should have added that the classification of a device may change from the MDD to the MDR. Because each has four device classes, there are 16 combinations

I should have added that there are only three states for a given device.

It meets the requirements under the MDD/AIMD

It is an EU-MDR Article 120 device (some MDD/AIMD and some MDR)

It is an EU-MDR device

There are also three states for an NB

Designated under the MDD/AIMD and supports Article 120

Designated under the MDD/AIMD and does not support Article 120

Designated under the MDR

It would seem that there are 3 × 3 = 9 states. However, there are Class I devices that don't need an NB under MDD and Class I devices that don't need an NB under MDR. The set of Class I devices is not the same in both cases.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

I should have added that the classification of a device may change from the MDD to the MDR. Because each has four device classes, there are 16 combinations

I should have added that there are only three states for a given device.

It meets the requirements under the MDD/AIMD

It is an EU-MDR Article 120 device (some MDD/AIMD and some MDR)

It is an EU-MDR device

There are also three states for an NB

Designated under the MDD/AIMD and supports Article 120

Designated under the MDD/AIMD and does not support Article 120

Designated under the MDR

It would seem that there are 3 × 3 = 9 states. However, there are Class I devices that don't need an NB under MDD and Class I devices that don't need an NB under MDR. The set of Class I devices is not the same in both cases.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

I should have added that the classification of a device may change from the MDD to the MDR. Because each has four device classes, there are 16 combinations

I should have added that there are only three states for a given device.

It meets the requirements under the MDD/AIMD

It is an EU-MDR Article 120 device (some MDD/AIMD and some MDR)

It is an EU-MDR device

There are also three states for an NB

Designated under the MDD/AIMD and supports Article 120

Designated under the MDD/AIMD and does not support Article 120

Designated under the MDR

It would seem that there are 3 × 3 = 9 states. However, there are Class I devices that don't need an NB under MDD and Class I devices that don't need an NB under MDR. The set of Class I devices is not the same in both cases.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

I should have added that the classification of a device may change from the MDD to the MDR. Because each has four device classes, there are 16 combinations

I should have added that there are only three states for a given device.

It meets the requirements under the MDD/AIMD

It is an EU-MDR Article 120 device (some MDD/AIMD and some MDR)

It is an EU-MDR device

There are also three states for an NB

Designated under the MDD/AIMD and supports Article 120

Designated under the MDD/AIMD and does not support Article 120

Designated under the MDR

It would seem that there are 3 × 3 = 9 states. However, there are Class I devices that don't need an NB under MDD and Class I devices that don't need an NB under MDR. The set of Class I devices is not the same in both cases.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

I should have added that the classification of a device may change from the MDD to the MDR. Because each has four device classes, there are 16 combinations

I should have added that there are only three states for a given device.

It meets the requirements under the MDD/AIMD

It is an EU-MDR Article 120 device (some MDD/AIMD and some MDR)

It is an EU-MDR device

There are also three states for an NB

Designated under the MDD/AIMD and supports Article 120

Designated under the MDD/AIMD and does not support Article 120

Designated under the MDR

It would seem that there are 3 × 3 = 9 states. However, there are Class I devices that don't need an NB under MDD and Class I devices that don't need an NB under MDR. The set of Class I devices is not the same in both cases.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

I should have added that the classification of a device may change from the MDD to the MDR. Because each has four device classes, there are 16 combinations

I should have added that there are only three states for a given device.

It meets the requirements under the MDD/AIMD

It is an EU-MDR Article 120 device (some MDD/AIMD and some MDR)

It is an EU-MDR device

There are also three states for an NB

Designated under the MDD/AIMD and supports Article 120

Designated under the MDD/AIMD and does not support Article 120

Designated under the MDR

It would seem that there are 3 × 3 = 9 states. However, there are Class I devices that don't need an NB under MDD and Class I devices that don't need an NB under MDR. The set of Class I devices is not the same in both cases.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

I should have added that the classification of a device may change from the MDD to the MDR. Because each has four device classes, there are 16 combinations

I should have added that there are only three states for a given device.

It meets the requirements under the MDD/AIMD

It is an EU-MDR Article 120 device (some MDD/AIMD and some MDR)

It is an EU-MDR device

There are also three states for an NB

Designated under the MDD/AIMD and supports Article 120

Designated under the MDD/AIMD and does not support Article 120

Designated under the MDR

It would seem that there are 3 × 3 = 9 states. However, there are Class I devices that don't need an NB under MDD and Class I devices that don't need an NB under MDR. The set of Class I devices is not the same in both cases.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

Thanks, Arthur.  Starting to get a little clearer on Class I devices.

Other than Class1 resuable and Class I software devices, are you aware of of any sizable group of up-classified devices that were self-certified under the MDD and will eventually need an MDR-designated NB?

So far the consensus seems to be that "software device" in this specific context (MDR up-classification) includes devices controlled by software, devices with embedded software, and SaMDs.  Do you agree?

As for the innovative devices, that's the only way I have been able to see this playing out.  I have no clue whether the EC understood that this would be the result, or, if it did, whether it wanted this result, or it just didn't care.  If it didn't care, was it just a coincidence, or did someone actively push for it? 

It's like the murder mystery of the medical device world...who killed innovative devices in the EU?  And why?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Jan-2020 02:02
From: Arthur Brandwood
Subject: Input needed from MDR gurus!

Julie

The reason for the Class I devices coming off the market was that if they were up-classified they would need a CE cert from day 1 - and most don't because of the paucity of NB options.  That has been fixed with the recent change, allowing devices already marketed in Europe to continue to be marketed until 2024. allowing time to get a CE MDR.  Evidence of prior marketing can be an existing MDD CE cert (required for I(s) and I(m) devices), or a self certified DofC for Class I.  All self certifed devices are required to be backed by a Tech File and DofC.

As for innovative devices, for sure that's exactly the problem.  New entrants will have no relationship with a Notified Body and they have all closed their doors to new clients  for the next couple of years.  See this blog...  https://brandwoodckc.com/the-door-to-europe-is-closed-where-else-should-i-look/ where I say:  "Put bluntly, while the rest of the world implements priority regulatory pathways for new technologies, Europe is closed for innovation."

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com

Original Message:
Sent: 20-Jan-2020 12:06
From: Julie Omohundro
Subject: Input needed from MDR gurus!

So now I have some specific high-level questions:

Does my logic seem to be on target?

Can anyone think of any reason why a lot of Class I devices should come off the EU market May 26?  It seem to me that most of them will be largely unaffected by this date.

Does anyone have any insights that might contradict the notion that innovative medical devices are dead in the EU?  I have looked at this several ways, and I keep coming back to my expectation that the MDR-designated NBs will not be inclined to want startups as clients.  Can anyone think of a reason that they would?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 16-Jan-2020 19:08
From: Julie Omohundro
Subject: Input needed from MDR gurus!

I'm trying to work out a high-level look at the impact the MDR is likely to have on the number of medical devices on the EU market before and after May 26.  Here's what I have so far.  I would be happy to have any corrections, additions, suggestions, or other comments from some of the MDR gurus here might offer, as I am not one:

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

Thanks, Arthur.  Starting to get a little clearer on Class I devices.

Other than Class1 resuable and Class I software devices, are you aware of of any sizable group of up-classified devices that were self-certified under the MDD and will eventually need an MDR-designated NB?

So far the consensus seems to be that "software device" in this specific context (MDR up-classification) includes devices controlled by software, devices with embedded software, and SaMDs.  Do you agree?

As for the innovative devices, that's the only way I have been able to see this playing out.  I have no clue whether the EC understood that this would be the result, or, if it did, whether it wanted this result, or it just didn't care.  If it didn't care, was it just a coincidence, or did someone actively push for it? 

It's like the murder mystery of the medical device world...who killed innovative devices in the EU?  And why?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Jan-2020 02:02
From: Arthur Brandwood
Subject: Input needed from MDR gurus!

Julie

The reason for the Class I devices coming off the market was that if they were up-classified they would need a CE cert from day 1 - and most don't because of the paucity of NB options.  That has been fixed with the recent change, allowing devices already marketed in Europe to continue to be marketed until 2024. allowing time to get a CE MDR.  Evidence of prior marketing can be an existing MDD CE cert (required for I(s) and I(m) devices), or a self certified DofC for Class I.  All self certifed devices are required to be backed by a Tech File and DofC.

As for innovative devices, for sure that's exactly the problem.  New entrants will have no relationship with a Notified Body and they have all closed their doors to new clients  for the next couple of years.  See this blog...  https://brandwoodckc.com/the-door-to-europe-is-closed-where-else-should-i-look/ where I say:  "Put bluntly, while the rest of the world implements priority regulatory pathways for new technologies, Europe is closed for innovation."

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com

Original Message:
Sent: 20-Jan-2020 12:06
From: Julie Omohundro
Subject: Input needed from MDR gurus!

So now I have some specific high-level questions:

Does my logic seem to be on target?

Can anyone think of any reason why a lot of Class I devices should come off the EU market May 26?  It seem to me that most of them will be largely unaffected by this date.

Does anyone have any insights that might contradict the notion that innovative medical devices are dead in the EU?  I have looked at this several ways, and I keep coming back to my expectation that the MDR-designated NBs will not be inclined to want startups as clients.  Can anyone think of a reason that they would?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 16-Jan-2020 19:08
From: Julie Omohundro
Subject: Input needed from MDR gurus!

I'm trying to work out a high-level look at the impact the MDR is likely to have on the number of medical devices on the EU market before and after May 26.  Here's what I have so far.  I would be happy to have any corrections, additions, suggestions, or other comments from some of the MDR gurus here might offer, as I am not one:

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

Hi Julie,

Interesting you mention start-ups. For the past two years I've been mentoring at two start-up accelerators in Berlin, Germany. The majority of ideas involved using software so the pressure has been on them to be CE marked according to MDD by May. Just being self declared class I was enough to be able to take advantage of the transition period. All the projects I am aware of managed to do it.

Thanks, Arthur.  Starting to get a little clearer on Class I devices.

Other than Class1 resuable and Class I software devices, are you aware of of any sizable group of up-classified devices that were self-certified under the MDD and will eventually need an MDR-designated NB?

So far the consensus seems to be that "software device" in this specific context (MDR up-classification) includes devices controlled by software, devices with embedded software, and SaMDs.  Do you agree?

As for the innovative devices, that's the only way I have been able to see this playing out.  I have no clue whether the EC understood that this would be the result, or, if it did, whether it wanted this result, or it just didn't care.  If it didn't care, was it just a coincidence, or did someone actively push for it? 

It's like the murder mystery of the medical device world...who killed innovative devices in the EU?  And why?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Jan-2020 02:02
From: Arthur Brandwood
Subject: Input needed from MDR gurus!

Julie

The reason for the Class I devices coming off the market was that if they were up-classified they would need a CE cert from day 1 - and most don't because of the paucity of NB options.  That has been fixed with the recent change, allowing devices already marketed in Europe to continue to be marketed until 2024. allowing time to get a CE MDR.  Evidence of prior marketing can be an existing MDD CE cert (required for I(s) and I(m) devices), or a self certified DofC for Class I.  All self certifed devices are required to be backed by a Tech File and DofC.

As for innovative devices, for sure that's exactly the problem.  New entrants will have no relationship with a Notified Body and they have all closed their doors to new clients  for the next couple of years.  See this blog...  https://brandwoodckc.com/the-door-to-europe-is-closed-where-else-should-i-look/ where I say:  "Put bluntly, while the rest of the world implements priority regulatory pathways for new technologies, Europe is closed for innovation."

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com

Original Message:
Sent: 20-Jan-2020 12:06
From: Julie Omohundro
Subject: Input needed from MDR gurus!

So now I have some specific high-level questions:

Does my logic seem to be on target?

Can anyone think of any reason why a lot of Class I devices should come off the EU market May 26?  It seem to me that most of them will be largely unaffected by this date.

Does anyone have any insights that might contradict the notion that innovative medical devices are dead in the EU?  I have looked at this several ways, and I keep coming back to my expectation that the MDR-designated NBs will not be inclined to want startups as clients.  Can anyone think of a reason that they would?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 16-Jan-2020 19:08
From: Julie Omohundro
Subject: Input needed from MDR gurus!

I'm trying to work out a high-level look at the impact the MDR is likely to have on the number of medical devices on the EU market before and after May 26.  Here's what I have so far.  I would be happy to have any corrections, additions, suggestions, or other comments from some of the MDR gurus here might offer, as I am not one:

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

OK, one more clarification would be appreciated!  Are there ANY devices...of ANY type or classification...that DO NOT have to conform to the MDR as of May 26?  Various devices are being given more time to get a certificate, but at least some still have to otherwise conform to the MDR as of May 26, right?  Are there any that do not?  (Other than IVDs, of course!!!)

Can someone PLEASE clear this up?

Thanks...

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

1. It meets the requirements under the MDD/AIMD
2. It is an EU-MDR Article 120 device
3. It is an EU-MDR device

OK, one more clarification would be appreciated!  Are there ANY devices...of ANY type or classification...that DO NOT have to conform to the MDR as of May 26?  Various devices are being given more time to get a certificate, but at least some still have to otherwise conform to the MDR as of May 26, right?  Are there any that do not?  (Other than IVDs, of course!!!)

Can someone PLEASE clear this up?

Thanks...

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

You ask, "Regarding the state of the Notified Bodies they (should) mimic above mentioned states, although I have not yet seen a designation of a Notified Body under article 120!? What happens if a Notified Body is not designated for MDR in time? Are they allowed to monitor the manufacturers and their products after 26 May 2020? Does somebody have information on this?"

The NBs do not get separate recognition for MDR Article 120. They operate under the MDD, so an NB without an MDR designation can still handle devices under Article 120.

In my analysis a device, not a manufacturer nor an NB, can be in one of three states:
Under full MDD
Under MDD as modified by MDR Article 120
Under full MDR

For the first two cases the NB must be designated for the MDD. For the third case the NB must be designated for the MDR.

1. It meets the requirements under the MDD/AIMD
2. It is an EU-MDR Article 120 device
3. It is an EU-MDR device

OK, one more clarification would be appreciated!  Are there ANY devices...of ANY type or classification...that DO NOT have to conform to the MDR as of May 26?  Various devices are being given more time to get a certificate, but at least some still have to otherwise conform to the MDR as of May 26, right?  Are there any that do not?  (Other than IVDs, of course!!!)

Can someone PLEASE clear this up?

Thanks...

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

You ask, "Regarding the state of the Notified Bodies they (should) mimic above mentioned states, although I have not yet seen a designation of a Notified Body under article 120!? What happens if a Notified Body is not designated for MDR in time? Are they allowed to monitor the manufacturers and their products after 26 May 2020? Does somebody have information on this?"

The NBs do not get separate recognition for MDR Article 120. They operate under the MDD, so an NB without an MDR designation can still handle devices under Article 120.

In my analysis a device, not a manufacturer nor an NB, can be in one of three states:
Under full MDD
Under MDD as modified by MDR Article 120
Under full MDR

For the first two cases the NB must be designated for the MDD. For the third case the NB must be designated for the MDR.

1. It meets the requirements under the MDD/AIMD
2. It is an EU-MDR Article 120 device
3. It is an EU-MDR device

OK, one more clarification would be appreciated!  Are there ANY devices...of ANY type or classification...that DO NOT have to conform to the MDR as of May 26?  Various devices are being given more time to get a certificate, but at least some still have to otherwise conform to the MDR as of May 26, right?  Are there any that do not?  (Other than IVDs, of course!!!)

Can someone PLEASE clear this up?

Thanks...

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

You ask, "Regarding the state of the Notified Bodies they (should) mimic above mentioned states, although I have not yet seen a designation of a Notified Body under article 120!? What happens if a Notified Body is not designated for MDR in time? Are they allowed to monitor the manufacturers and their products after 26 May 2020? Does somebody have information on this?"

The NBs do not get separate recognition for MDR Article 120. They operate under the MDD, so an NB without an MDR designation can still handle devices under Article 120.

In my analysis a device, not a manufacturer nor an NB, can be in one of three states:
Under full MDD
Under MDD as modified by MDR Article 120
Under full MDR

For the first two cases the NB must be designated for the MDD. For the third case the NB must be designated for the MDR.

1. It meets the requirements under the MDD/AIMD
2. It is an EU-MDR Article 120 device
3. It is an EU-MDR device

OK, one more clarification would be appreciated!  Are there ANY devices...of ANY type or classification...that DO NOT have to conform to the MDR as of May 26?  Various devices are being given more time to get a certificate, but at least some still have to otherwise conform to the MDR as of May 26, right?  Are there any that do not?  (Other than IVDs, of course!!!)

Can someone PLEASE clear this up?

Thanks...

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

Let me clarify the situation.

On the date of application of the MDR, the MDD does not become void. It will live on for many years.

In the MDR Article 120(1) it is the notification of the NB that becomes void. This means there will be no new MDD NBs nor new device certificates to the MDD.

Article 120(3)(second paragraph) says that the NB that issued the certificate is responsible for surveillance.

So, when the NB conducts surveillance what are the requirements? The answer is in Article 120(3). The manufacturer must comply with the MDD except for (as enumerated):
No significant design changes
No significant intended use changes
Post-market surveillance from the MDR, not the MDD
Market surveillance from the MDR, not the MDD
Vigilance from the MDR, not the MDD
Economic operator registration from the MDR, not the MDD
Device registration from the MDR, not the MDD

As a result, the device is not fully compliant with the MDD. Also, the device is not fully compliant with the MDR. It is compliant with a hybrid, the MDD as modified by MDR Article 120. The DoC must be correct, so it must state the hybrid state.

You ask, "Regarding the state of the Notified Bodies they (should) mimic above mentioned states, although I have not yet seen a designation of a Notified Body under article 120!? What happens if a Notified Body is not designated for MDR in time? Are they allowed to monitor the manufacturers and their products after 26 May 2020? Does somebody have information on this?"

The NBs do not get separate recognition for MDR Article 120. They operate under the MDD, so an NB without an MDR designation can still handle devices under Article 120.

In my analysis a device, not a manufacturer nor an NB, can be in one of three states:
Under full MDD
Under MDD as modified by MDR Article 120
Under full MDR

For the first two cases the NB must be designated for the MDD. For the third case the NB must be designated for the MDR.

1. It meets the requirements under the MDD/AIMD
2. It is an EU-MDR Article 120 device
3. It is an EU-MDR device

OK, one more clarification would be appreciated!  Are there ANY devices...of ANY type or classification...that DO NOT have to conform to the MDR as of May 26?  Various devices are being given more time to get a certificate, but at least some still have to otherwise conform to the MDR as of May 26, right?  Are there any that do not?  (Other than IVDs, of course!!!)

Can someone PLEASE clear this up?

Thanks...

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

1. It meets the requirements under the MDD/AIMD
2. It is an EU-MDR Article 120 device
3. It is an EU-MDR device

OK, one more clarification would be appreciated!  Are there ANY devices...of ANY type or classification...that DO NOT have to conform to the MDR as of May 26?  Various devices are being given more time to get a certificate, but at least some still have to otherwise conform to the MDR as of May 26, right?  Are there any that do not?  (Other than IVDs, of course!!!)

Can someone PLEASE clear this up?

Thanks...

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

1. It meets the requirements under the MDD/AIMD
2. It is an EU-MDR Article 120 device
3. It is an EU-MDR device

OK, one more clarification would be appreciated!  Are there ANY devices...of ANY type or classification...that DO NOT have to conform to the MDR as of May 26?  Various devices are being given more time to get a certificate, but at least some still have to otherwise conform to the MDR as of May 26, right?  Are there any that do not?  (Other than IVDs, of course!!!)

Can someone PLEASE clear this up?

Thanks...

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

OK, one more clarification would be appreciated!  Are there ANY devices...of ANY type or classification...that DO NOT have to conform to the MDR as of May 26?  Various devices are being given more time to get a certificate, but at least some still have to otherwise conform to the MDR as of May 26, right?  Are there any that do not?  (Other than IVDs, of course!!!)

Can someone PLEASE clear this up?

Thanks...

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices

Groups A and B

These devices are in one of two situations:

1. The NB that issued their MDD certificates will continue to provide NB services through the transition. In this case, these devices can remain on the EU market without an MDR-designated NB for another 2-4 years. They must still conform to the requirements of the MDR.
2. The NB that issued their MDD certificates will not continue to provide NB services through the transition. Apparently the main determinant here is whether their medical device staff think that their employer will eventually be MDR-designated. If not, they are prone to a sudden desire to seek their future elsewhere, leaving no one left to provide the services.

According to the October 2019 Joint Assessments Report, 40 notified bodies have sought designation under the MDR.  As of now, 9 have been designated.  Whether any of the remaining 31 will fail to secure designation is unknown, but it seems probable that these 40 NBs were still renewing MDD certificates through May 25 2019 and that their staff feel no pressing need to seek employment elsewhere, so they currently are expecting to offer MDD services through the transition. 

Therefore, as of now, most of the devices in Groups A and B will apparently be able to ride their MDD certificates through at least May 26 2022.

Group C

These devices give new meaning to being "at an awkward age."  If their manufacturers were very forward looking, they renewed their MDD certifications early, which puts them in the same position as the devices in Groups A and B.  But probably few of their manufacturers expected NB capacity to get this tight, so they probably decided they would forego renewal for these devices and pursue MDR designation instead. Oops. Some of these devices--those that had MDD certification from an NB that secured MDR designation in 2019--will get MDR certification by May 26, but the majority will probably still be waiting in queue.

Groups D and E

None of the devices in these groups can ride their MDD certificates past May 26, so their manufacturers should have started to prepare early.  Those that were fortunate enough to hold MDD certificates from one of the NBs that were certified in 2019 should be well positioned to get their certificates by May 26, or shortly enough thereafter so as not to be a huge problem. The same is true for a small percentage holding MDD certificates from NBs certified in early 2020.  The rest will probably get MDR certificates sometime in 2020…IF the NB that holds their MDD certificates gets MDR designated.

• Some companies may give up on the European market altogether, if they don't have a lot of sales there, not wanting to accept the increased costs, increased liability, required transparency, etc.
• Some companies don't have the will to implement all the new requirements on time, and may withdraw temporarily.
• Some companies may want to stay in the market, but be refused by their former authorized reps. The EC REPs have more liability under the MDR if they accept products with inadequate documentation.

OK, one more clarification would be appreciated!  Are there ANY devices...of ANY type or classification...that DO NOT have to conform to the MDR as of May 26?  Various devices are being given more time to get a certificate, but at least some still have to otherwise conform to the MDR as of May 26, right?  Are there any that do not?  (Other than IVDs, of course!!!)

Can someone PLEASE clear this up?

Thanks...

Expiration and Renewal Timeframes for MDD-Certified Class II-III Medical Devices