Regulatory Open Forum

Per Article 120(3) of the MDR, we are allowed to continue putting our devices on the market that are CE Marked under the MDD after the MDR goes into effect in May 2020 under their MDD certificate provided the cert is still valid, there are no significant changes in design or intended purpose of the device.  That seems clear - if we want to make a significant change to the intended purpose of the device or the design of the device, we have to submit it under MDR and get it CE Marked under the MDR regulation.  All was well and good until someone provided me the attached FAQ published by the CAMD Transition Sub Group.

On page 10, in response to question 17 about placing MDD compliant devices on the market after MDR DoA, the CAMD states:

SO....I'm wondering if any of you have an interpretation or guidance on the "design changes related to corrective actions assessed and accepted by the CA" as not being considered a significant change?

I might be missing something here, but the only design changes related to corrective actions that I can think of where the CA gets involved are those related to FSCAs.  Are they stating that we are allowed to make changes to our MDD certified devices if it is a change to correct a safety issue and we can remain under our MDD certificate and not have to automatically move that device under MDR?  What am I missing and what do you guys think?

Per Article 120(3) of the MDR, we are allowed to continue putting our devices on the market that are CE Marked under the MDD after the MDR goes into effect in May 2020 under their MDD certificate provided the cert is still valid, there are no significant changes in design or intended purpose of the device.  That seems clear - if we want to make a significant change to the intended purpose of the device or the design of the device, we have to submit it under MDR and get it CE Marked under the MDR regulation.  All was well and good until someone provided me the attached FAQ published by the CAMD Transition Sub Group.

On page 10, in response to question 17 about placing MDD compliant devices on the market after MDR DoA, the CAMD states:

SO....I'm wondering if any of you have an interpretation or guidance on the "design changes related to corrective actions assessed and accepted by the CA" as not being considered a significant change?

I might be missing something here, but the only design changes related to corrective actions that I can think of where the CA gets involved are those related to FSCAs.  Are they stating that we are allowed to make changes to our MDD certified devices if it is a change to correct a safety issue and we can remain under our MDD certificate and not have to automatically move that device under MDR?  What am I missing and what do you guys think?

Thank you!

Richard, you hit the nail on the head.  I guess I'm surprised that they would consider a change made due to a corrective action assessed and accepted by the CA as a non-significant change.  So, if we are still marketing our device under MDD and that were to occur, we could make the change and continue to market under MDD because we wouldn't have to report it to the NB as a significant change (even though they would already be aware b/c of the FSCA reporting).  I'm skeptical that a NB would find this acceptable.  Yet, this document was published by the CAMD.

As we plan the transition of our products to MDR, I am working to establish guidelines for my company around types of changes that can and cannot be made on the various products at their various stages (MDD certified, Post NB MDD Cutoff, Under MDR Review, Post MDR Review) and this one has me stumped.

Per Article 120(3) of the MDR, we are allowed to continue putting our devices on the market that are CE Marked under the MDD after the MDR goes into effect in May 2020 under their MDD certificate provided the cert is still valid, there are no significant changes in design or intended purpose of the device.  That seems clear - if we want to make a significant change to the intended purpose of the device or the design of the device, we have to submit it under MDR and get it CE Marked under the MDR regulation.  All was well and good until someone provided me the attached FAQ published by the CAMD Transition Sub Group.

On page 10, in response to question 17 about placing MDD compliant devices on the market after MDR DoA, the CAMD states:

SO....I'm wondering if any of you have an interpretation or guidance on the "design changes related to corrective actions assessed and accepted by the CA" as not being considered a significant change?

I might be missing something here, but the only design changes related to corrective actions that I can think of where the CA gets involved are those related to FSCAs.  Are they stating that we are allowed to make changes to our MDD certified devices if it is a change to correct a safety issue and we can remain under our MDD certificate and not have to automatically move that device under MDR?  What am I missing and what do you guys think?

Thank you!

Richard, you hit the nail on the head.  I guess I'm surprised that they would consider a change made due to a corrective action assessed and accepted by the CA as a non-significant change.  So, if we are still marketing our device under MDD and that were to occur, we could make the change and continue to market under MDD because we wouldn't have to report it to the NB as a significant change (even though they would already be aware b/c of the FSCA reporting).  I'm skeptical that a NB would find this acceptable.  Yet, this document was published by the CAMD.

As we plan the transition of our products to MDR, I am working to establish guidelines for my company around types of changes that can and cannot be made on the various products at their various stages (MDD certified, Post NB MDD Cutoff, Under MDR Review, Post MDR Review) and this one has me stumped.

Per Article 120(3) of the MDR, we are allowed to continue putting our devices on the market that are CE Marked under the MDD after the MDR goes into effect in May 2020 under their MDD certificate provided the cert is still valid, there are no significant changes in design or intended purpose of the device.  That seems clear - if we want to make a significant change to the intended purpose of the device or the design of the device, we have to submit it under MDR and get it CE Marked under the MDR regulation.  All was well and good until someone provided me the attached FAQ published by the CAMD Transition Sub Group.

On page 10, in response to question 17 about placing MDD compliant devices on the market after MDR DoA, the CAMD states:

SO....I'm wondering if any of you have an interpretation or guidance on the "design changes related to corrective actions assessed and accepted by the CA" as not being considered a significant change?

I might be missing something here, but the only design changes related to corrective actions that I can think of where the CA gets involved are those related to FSCAs.  Are they stating that we are allowed to make changes to our MDD certified devices if it is a change to correct a safety issue and we can remain under our MDD certificate and not have to automatically move that device under MDR?  What am I missing and what do you guys think?

Thanks Roger!

If I understand what you are saying correctly, this paragraph is telling us that if we make a corrective or preventive change based on information obtained from PMS (an example could be a non-serious incident or a noticed trend that we decided to open a CAPA for and make a design change), then we have to notify the CA and NB.  If the CA accepts the change, then per the CAMD guidance, it would not be considered a significant change for reporting to the NB.  Is that correct?

I was overlooking the fact that Article 83 will be effective even though the device would still be under its MDD certification, since that article is one of the mandatory articles that goes into effect May 2020 even if no products are being submitted for CE certification under MDR at that time.

-A

Thank you!

Richard, you hit the nail on the head.  I guess I'm surprised that they would consider a change made due to a corrective action assessed and accepted by the CA as a non-significant change.  So, if we are still marketing our device under MDD and that were to occur, we could make the change and continue to market under MDD because we wouldn't have to report it to the NB as a significant change (even though they would already be aware b/c of the FSCA reporting).  I'm skeptical that a NB would find this acceptable.  Yet, this document was published by the CAMD.

As we plan the transition of our products to MDR, I am working to establish guidelines for my company around types of changes that can and cannot be made on the various products at their various stages (MDD certified, Post NB MDD Cutoff, Under MDR Review, Post MDR Review) and this one has me stumped.

Per Article 120(3) of the MDR, we are allowed to continue putting our devices on the market that are CE Marked under the MDD after the MDR goes into effect in May 2020 under their MDD certificate provided the cert is still valid, there are no significant changes in design or intended purpose of the device.  That seems clear - if we want to make a significant change to the intended purpose of the device or the design of the device, we have to submit it under MDR and get it CE Marked under the MDR regulation.  All was well and good until someone provided me the attached FAQ published by the CAMD Transition Sub Group.

On page 10, in response to question 17 about placing MDD compliant devices on the market after MDR DoA, the CAMD states:

SO....I'm wondering if any of you have an interpretation or guidance on the "design changes related to corrective actions assessed and accepted by the CA" as not being considered a significant change?

I might be missing something here, but the only design changes related to corrective actions that I can think of where the CA gets involved are those related to FSCAs.  Are they stating that we are allowed to make changes to our MDD certified devices if it is a change to correct a safety issue and we can remain under our MDD certificate and not have to automatically move that device under MDR?  What am I missing and what do you guys think?

Thanks Roger!

If I understand what you are saying correctly, this paragraph is telling us that if we make a corrective or preventive change based on information obtained from PMS (an example could be a non-serious incident or a noticed trend that we decided to open a CAPA for and make a design change), then we have to notify the CA and NB.  If the CA accepts the change, then per the CAMD guidance, it would not be considered a significant change for reporting to the NB.  Is that correct?

I was overlooking the fact that Article 83 will be effective even though the device would still be under its MDD certification, since that article is one of the mandatory articles that goes into effect May 2020 even if no products are being submitted for CE certification under MDR at that time.

-A

Thank you!

Richard, you hit the nail on the head.  I guess I'm surprised that they would consider a change made due to a corrective action assessed and accepted by the CA as a non-significant change.  So, if we are still marketing our device under MDD and that were to occur, we could make the change and continue to market under MDD because we wouldn't have to report it to the NB as a significant change (even though they would already be aware b/c of the FSCA reporting).  I'm skeptical that a NB would find this acceptable.  Yet, this document was published by the CAMD.

As we plan the transition of our products to MDR, I am working to establish guidelines for my company around types of changes that can and cannot be made on the various products at their various stages (MDD certified, Post NB MDD Cutoff, Under MDR Review, Post MDR Review) and this one has me stumped.

Per Article 120(3) of the MDR, we are allowed to continue putting our devices on the market that are CE Marked under the MDD after the MDR goes into effect in May 2020 under their MDD certificate provided the cert is still valid, there are no significant changes in design or intended purpose of the device.  That seems clear - if we want to make a significant change to the intended purpose of the device or the design of the device, we have to submit it under MDR and get it CE Marked under the MDR regulation.  All was well and good until someone provided me the attached FAQ published by the CAMD Transition Sub Group.

On page 10, in response to question 17 about placing MDD compliant devices on the market after MDR DoA, the CAMD states:

SO....I'm wondering if any of you have an interpretation or guidance on the "design changes related to corrective actions assessed and accepted by the CA" as not being considered a significant change?

I might be missing something here, but the only design changes related to corrective actions that I can think of where the CA gets involved are those related to FSCAs.  Are they stating that we are allowed to make changes to our MDD certified devices if it is a change to correct a safety issue and we can remain under our MDD certificate and not have to automatically move that device under MDR?  What am I missing and what do you guys think?

Per Article 120(3) of the MDR, we are allowed to continue putting our devices on the market that are CE Marked under the MDD after the MDR goes into effect in May 2020 under their MDD certificate provided the cert is still valid, there are no significant changes in design or intended purpose of the device.  That seems clear - if we want to make a significant change to the intended purpose of the device or the design of the device, we have to submit it under MDR and get it CE Marked under the MDR regulation.  All was well and good until someone provided me the attached FAQ published by the CAMD Transition Sub Group.

On page 10, in response to question 17 about placing MDD compliant devices on the market after MDR DoA, the CAMD states:

SO....I'm wondering if any of you have an interpretation or guidance on the "design changes related to corrective actions assessed and accepted by the CA" as not being considered a significant change?

I might be missing something here, but the only design changes related to corrective actions that I can think of where the CA gets involved are those related to FSCAs.  Are they stating that we are allowed to make changes to our MDD certified devices if it is a change to correct a safety issue and we can remain under our MDD certificate and not have to automatically move that device under MDR?  What am I missing and what do you guys think?

Per Article 120(3) of the MDR, we are allowed to continue putting our devices on the market that are CE Marked under the MDD after the MDR goes into effect in May 2020 under their MDD certificate provided the cert is still valid, there are no significant changes in design or intended purpose of the device.  That seems clear - if we want to make a significant change to the intended purpose of the device or the design of the device, we have to submit it under MDR and get it CE Marked under the MDR regulation.  All was well and good until someone provided me the attached FAQ published by the CAMD Transition Sub Group.

On page 10, in response to question 17 about placing MDD compliant devices on the market after MDR DoA, the CAMD states:

SO....I'm wondering if any of you have an interpretation or guidance on the "design changes related to corrective actions assessed and accepted by the CA" as not being considered a significant change?

I might be missing something here, but the only design changes related to corrective actions that I can think of where the CA gets involved are those related to FSCAs.  Are they stating that we are allowed to make changes to our MDD certified devices if it is a change to correct a safety issue and we can remain under our MDD certificate and not have to automatically move that device under MDR?  What am I missing and what do you guys think?

Per Article 120(3) of the MDR, we are allowed to continue putting our devices on the market that are CE Marked under the MDD after the MDR goes into effect in May 2020 under their MDD certificate provided the cert is still valid, there are no significant changes in design or intended purpose of the device.  That seems clear - if we want to make a significant change to the intended purpose of the device or the design of the device, we have to submit it under MDR and get it CE Marked under the MDR regulation.  All was well and good until someone provided me the attached FAQ published by the CAMD Transition Sub Group.

On page 10, in response to question 17 about placing MDD compliant devices on the market after MDR DoA, the CAMD states:

SO....I'm wondering if any of you have an interpretation or guidance on the "design changes related to corrective actions assessed and accepted by the CA" as not being considered a significant change?

I might be missing something here, but the only design changes related to corrective actions that I can think of where the CA gets involved are those related to FSCAs.  Are they stating that we are allowed to make changes to our MDD certified devices if it is a change to correct a safety issue and we can remain under our MDD certificate and not have to automatically move that device under MDR?  What am I missing and what do you guys think?

Per Article 120(3) of the MDR, we are allowed to continue putting our devices on the market that are CE Marked under the MDD after the MDR goes into effect in May 2020 under their MDD certificate provided the cert is still valid, there are no significant changes in design or intended purpose of the device.  That seems clear - if we want to make a significant change to the intended purpose of the device or the design of the device, we have to submit it under MDR and get it CE Marked under the MDR regulation.  All was well and good until someone provided me the attached FAQ published by the CAMD Transition Sub Group.

On page 10, in response to question 17 about placing MDD compliant devices on the market after MDR DoA, the CAMD states:

SO....I'm wondering if any of you have an interpretation or guidance on the "design changes related to corrective actions assessed and accepted by the CA" as not being considered a significant change?

I might be missing something here, but the only design changes related to corrective actions that I can think of where the CA gets involved are those related to FSCAs.  Are they stating that we are allowed to make changes to our MDD certified devices if it is a change to correct a safety issue and we can remain under our MDD certificate and not have to automatically move that device under MDR?  What am I missing and what do you guys think?