Regulatory Open Forum

In my opinion, the only viable option is the MDR. Trying to get a CE Mark under the MDD and then using the Article 120 soft transition is far too much work. You would need to implement the MDD and have an MDD audit (devices and QMS). Then under the Article 120 transition you would need another audit for the hybrid QMS required under Article 120. The good news is that you would have time to develop a full MDR QMS and Full MDR technical documentation. The bad news is that you would need an MDD NB that plans to become an MDR NB and has the capacity to take on a new client. I doubt there are any.

Worse, you would need to undo the MDD QMS and technical documentation and redo it for the MDR. They are so different, a simple gap analysis with minor adjustments is not sufficient.

Leonard Eisner said, "you should make sure the NBs you are talking to have Designation for the type of devices you design & manufacture". This is excellent advice. I my courses I find that people don't know what this means or how to answer the question.

First, under both the MDD and the MDR, an NB is not necessarily notified for the whole directive or regulation, only parts for which they apply and can demonstrate competence. The parts use sets of codes which are not the same for the MDD and the MDR. (Under the MDD these codes form part of the basis for NB sampling plans for certain device classes.)

The list of NBs is at the NANDO website http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main Use caution, because a Google search for NANDO will take you to a large restaurant chain!

The page has the legislation that requires an NB. Scroll down to "Regulation (EU) 2017/745 on medical devices" and open the hyperlink. Today, you will find two organizations listed. (Some day, this will be a longer list.) Click on, for example, "TÜV SÜD Product Service GmbH Zertifizierstellen" and you will get a list of the regulations for which this company is an NB. Click on the PDF link associated with "Regulation (EU) 2017/745 on medical devices" and you will get a multi-page document. It has two lists of codes: "Codes Reflecting the Design and Intended Purpose of the Device" and "Horizontal Technical Competence". If your device isn't in a Combination of the Two (which is also a great Janis Joplin song), then the NB must reject any application you submit. Clearly you can ask them in advance.

In short, start with the MDR. It is a lot of work by itself, but, as I said, is the path that requires the least resources and has the best opportunity for success.

In my opinion, the only viable option is the MDR. Trying to get a CE Mark under the MDD and then using the Article 120 soft transition is far too much work. You would need to implement the MDD and have an MDD audit (devices and QMS). Then under the Article 120 transition you would need another audit for the hybrid QMS required under Article 120. The good news is that you would have time to develop a full MDR QMS and Full MDR technical documentation. The bad news is that you would need an MDD NB that plans to become an MDR NB and has the capacity to take on a new client. I doubt there are any.

Worse, you would need to undo the MDD QMS and technical documentation and redo it for the MDR. They are so different, a simple gap analysis with minor adjustments is not sufficient.

Leonard Eisner said, "you should make sure the NBs you are talking to have Designation for the type of devices you design & manufacture". This is excellent advice. I my courses I find that people don't know what this means or how to answer the question.

First, under both the MDD and the MDR, an NB is not necessarily notified for the whole directive or regulation, only parts for which they apply and can demonstrate competence. The parts use sets of codes which are not the same for the MDD and the MDR. (Under the MDD these codes form part of the basis for NB sampling plans for certain device classes.)

The list of NBs is at the NANDO website http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main Use caution, because a Google search for NANDO will take you to a large restaurant chain!

The page has the legislation that requires an NB. Scroll down to "Regulation (EU) 2017/745 on medical devices" and open the hyperlink. Today, you will find two organizations listed. (Some day, this will be a longer list.) Click on, for example, "TÜV SÜD Product Service GmbH Zertifizierstellen" and you will get a list of the regulations for which this company is an NB. Click on the PDF link associated with "Regulation (EU) 2017/745 on medical devices" and you will get a multi-page document. It has two lists of codes: "Codes Reflecting the Design and Intended Purpose of the Device" and "Horizontal Technical Competence". If your device isn't in a Combination of the Two (which is also a great Janis Joplin song), then the NB must reject any application you submit. Clearly you can ask them in advance.

In short, start with the MDR. It is a lot of work by itself, but, as I said, is the path that requires the least resources and has the best opportunity for success.

Jon,

That is exactly what I mean. Assume you used MDD Annex II. Then you would have implemented EN ISO 13485:2016/AC2018, Annex ZB, Table ZB.1. The table is about two pages.

When you get to the MDR, you will implement a QMS that satisfies Article 10(9). There are about 15 requirements for the QMS, many of which are not in EN ISO 13485:2016/AC2018. To understand the differences, you should look at CEN/TR 17223:2018. Table 1 explains the requirements and shows the areas not covered by ISO 13485:2016. It is about 36 pages long.

In my opinion, the only viable option is the MDR. Trying to get a CE Mark under the MDD and then using the Article 120 soft transition is far too much work. You would need to implement the MDD and have an MDD audit (devices and QMS). Then under the Article 120 transition you would need another audit for the hybrid QMS required under Article 120. The good news is that you would have time to develop a full MDR QMS and Full MDR technical documentation. The bad news is that you would need an MDD NB that plans to become an MDR NB and has the capacity to take on a new client. I doubt there are any.

Worse, you would need to undo the MDD QMS and technical documentation and redo it for the MDR. They are so different, a simple gap analysis with minor adjustments is not sufficient.

Leonard Eisner said, "you should make sure the NBs you are talking to have Designation for the type of devices you design & manufacture". This is excellent advice. I my courses I find that people don't know what this means or how to answer the question.

First, under both the MDD and the MDR, an NB is not necessarily notified for the whole directive or regulation, only parts for which they apply and can demonstrate competence. The parts use sets of codes which are not the same for the MDD and the MDR. (Under the MDD these codes form part of the basis for NB sampling plans for certain device classes.)

The list of NBs is at the NANDO website http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main Use caution, because a Google search for NANDO will take you to a large restaurant chain!

The page has the legislation that requires an NB. Scroll down to "Regulation (EU) 2017/745 on medical devices" and open the hyperlink. Today, you will find two organizations listed. (Some day, this will be a longer list.) Click on, for example, "TÜV SÜD Product Service GmbH Zertifizierstellen" and you will get a list of the regulations for which this company is an NB. Click on the PDF link associated with "Regulation (EU) 2017/745 on medical devices" and you will get a multi-page document. It has two lists of codes: "Codes Reflecting the Design and Intended Purpose of the Device" and "Horizontal Technical Competence". If your device isn't in a Combination of the Two (which is also a great Janis Joplin song), then the NB must reject any application you submit. Clearly you can ask them in advance.

In short, start with the MDR. It is a lot of work by itself, but, as I said, is the path that requires the least resources and has the best opportunity for success.

Jon,

That is exactly what I mean. Assume you used MDD Annex II. Then you would have implemented EN ISO 13485:2016/AC2018, Annex ZB, Table ZB.1. The table is about two pages.

When you get to the MDR, you will implement a QMS that satisfies Article 10(9). There are about 15 requirements for the QMS, many of which are not in EN ISO 13485:2016/AC2018. To understand the differences, you should look at CEN/TR 17223:2018. Table 1 explains the requirements and shows the areas not covered by ISO 13485:2016. It is about 36 pages long.

In my opinion, the only viable option is the MDR. Trying to get a CE Mark under the MDD and then using the Article 120 soft transition is far too much work. You would need to implement the MDD and have an MDD audit (devices and QMS). Then under the Article 120 transition you would need another audit for the hybrid QMS required under Article 120. The good news is that you would have time to develop a full MDR QMS and Full MDR technical documentation. The bad news is that you would need an MDD NB that plans to become an MDR NB and has the capacity to take on a new client. I doubt there are any.

Worse, you would need to undo the MDD QMS and technical documentation and redo it for the MDR. They are so different, a simple gap analysis with minor adjustments is not sufficient.

Leonard Eisner said, "you should make sure the NBs you are talking to have Designation for the type of devices you design & manufacture". This is excellent advice. I my courses I find that people don't know what this means or how to answer the question.

First, under both the MDD and the MDR, an NB is not necessarily notified for the whole directive or regulation, only parts for which they apply and can demonstrate competence. The parts use sets of codes which are not the same for the MDD and the MDR. (Under the MDD these codes form part of the basis for NB sampling plans for certain device classes.)

The list of NBs is at the NANDO website http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main Use caution, because a Google search for NANDO will take you to a large restaurant chain!

The page has the legislation that requires an NB. Scroll down to "Regulation (EU) 2017/745 on medical devices" and open the hyperlink. Today, you will find two organizations listed. (Some day, this will be a longer list.) Click on, for example, "TÜV SÜD Product Service GmbH Zertifizierstellen" and you will get a list of the regulations for which this company is an NB. Click on the PDF link associated with "Regulation (EU) 2017/745 on medical devices" and you will get a multi-page document. It has two lists of codes: "Codes Reflecting the Design and Intended Purpose of the Device" and "Horizontal Technical Competence". If your device isn't in a Combination of the Two (which is also a great Janis Joplin song), then the NB must reject any application you submit. Clearly you can ask them in advance.

In short, start with the MDR. It is a lot of work by itself, but, as I said, is the path that requires the least resources and has the best opportunity for success.

Jon,

That is exactly what I mean. Assume you used MDD Annex II. Then you would have implemented EN ISO 13485:2016/AC2018, Annex ZB, Table ZB.1. The table is about two pages.

When you get to the MDR, you will implement a QMS that satisfies Article 10(9). There are about 15 requirements for the QMS, many of which are not in EN ISO 13485:2016/AC2018. To understand the differences, you should look at CEN/TR 17223:2018. Table 1 explains the requirements and shows the areas not covered by ISO 13485:2016. It is about 36 pages long.

In my opinion, the only viable option is the MDR. Trying to get a CE Mark under the MDD and then using the Article 120 soft transition is far too much work. You would need to implement the MDD and have an MDD audit (devices and QMS). Then under the Article 120 transition you would need another audit for the hybrid QMS required under Article 120. The good news is that you would have time to develop a full MDR QMS and Full MDR technical documentation. The bad news is that you would need an MDD NB that plans to become an MDR NB and has the capacity to take on a new client. I doubt there are any.

Worse, you would need to undo the MDD QMS and technical documentation and redo it for the MDR. They are so different, a simple gap analysis with minor adjustments is not sufficient.

Leonard Eisner said, "you should make sure the NBs you are talking to have Designation for the type of devices you design & manufacture". This is excellent advice. I my courses I find that people don't know what this means or how to answer the question.

First, under both the MDD and the MDR, an NB is not necessarily notified for the whole directive or regulation, only parts for which they apply and can demonstrate competence. The parts use sets of codes which are not the same for the MDD and the MDR. (Under the MDD these codes form part of the basis for NB sampling plans for certain device classes.)

The list of NBs is at the NANDO website http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main Use caution, because a Google search for NANDO will take you to a large restaurant chain!

The page has the legislation that requires an NB. Scroll down to "Regulation (EU) 2017/745 on medical devices" and open the hyperlink. Today, you will find two organizations listed. (Some day, this will be a longer list.) Click on, for example, "TÜV SÜD Product Service GmbH Zertifizierstellen" and you will get a list of the regulations for which this company is an NB. Click on the PDF link associated with "Regulation (EU) 2017/745 on medical devices" and you will get a multi-page document. It has two lists of codes: "Codes Reflecting the Design and Intended Purpose of the Device" and "Horizontal Technical Competence". If your device isn't in a Combination of the Two (which is also a great Janis Joplin song), then the NB must reject any application you submit. Clearly you can ask them in advance.

In short, start with the MDR. It is a lot of work by itself, but, as I said, is the path that requires the least resources and has the best opportunity for success.