Regulatory Open Forum

Ed,

Thank you for this exciting news. Could you clarify a few things for me?

Will CEN publish 14971 without Annex ZA to ZE from the FDIS? Does CEN intend to add their own annexes? I infer that when CEN publishes, it will have been standardized but not harmonized.

The forecast for publication is December 2019. Is this for 14971, 24971, or both? It would be great if they came out together.

In response to your questions Dan:

1.  There will be no Z Annexes due to the lack of agreement in the EC over a harmonization process within the MDR and IVDR.  The presently published "Harmonized" standards are not harmonized to the MDR and IVDR (only to the directives) so they have no status to support the new regulatory requirements in those documents.  Presently the manufacturer is "one his own" to demonstrate compliance with the new regulations, and may develop their own tables to show how their quality system meets those requirements.  CEN will not publish Z Annexes with the standard, it will look exactly like the ISO version with no deviations, just as AAMI does with the US versions of standards.  The new EN ISO 14971:2019 should replace the EN ISO 14971:2012 immediately, in my estimation, as it is a better document that addresses the issues that were found in the earlier version.

The problems in the EC with the implementation of the MDR and IVDR continue with things like the lack of agreement on Harmonization, the lack of sufficient Notified Bodies and the lack of auditors and other experts within the Notified Bodies to support all product types.  Just because a Notified Body is appointed doesn't mean they can certify all device types, their certification must identify the types of devices they can support.  Then their are other aspects, like Eudamed that are necessary to complete the process for the manufacturer.

I fear that the EC may release a lot of the elements right before the "drop dead date", and declare the process complete and question why that devices are not available in the EU.  Much like the furor over Brexit and the warnings being issued that there will be a drug shortage, the EC issued warnings in the summer to hospitals about the expected shortage of medical devices.  This has not been widely reported, but is expected to happen.

2. The standard, ISO 14971 and the technical report, ISO TR 24971 are to be released together or within days of each other, as it will be vital because of the reorganization of the two to have them together. That was the focus of the efforts of the Joint Working Group in the last few months, to synchronize the release of the two documents.  The new technical report is over 100 pages, where the standard previously had 68 pages of informative annexes.  There are a few pages of the original informative annexes still in the standard, so you can see the amount of work that has been done to improve the risk management guidance without major revisions to the requirements.  The requirements page count is still about 15 pages.  But, for instance the production / post-production requirements went from a few paragraphs to 2 pages of requirements, and the supporting guidance in the technical report went from 1 page to 10 pages.  That aspect of the risk management process had lots of input from the regulators, like FDA to better explain the process.   

Ed,

Thank you for this exciting news. Could you clarify a few things for me?

Will CEN publish 14971 without Annex ZA to ZE from the FDIS? Does CEN intend to add their own annexes? I infer that when CEN publishes, it will have been standardized but not harmonized.

The forecast for publication is December 2019. Is this for 14971, 24971, or both? It would be great if they came out together.

In response to your questions Dan:

1.  There will be no Z Annexes due to the lack of agreement in the EC over a harmonization process within the MDR and IVDR.  The presently published "Harmonized" standards are not harmonized to the MDR and IVDR (only to the directives) so they have no status to support the new regulatory requirements in those documents.  Presently the manufacturer is "one his own" to demonstrate compliance with the new regulations, and may develop their own tables to show how their quality system meets those requirements.  CEN will not publish Z Annexes with the standard, it will look exactly like the ISO version with no deviations, just as AAMI does with the US versions of standards.  The new EN ISO 14971:2019 should replace the EN ISO 14971:2012 immediately, in my estimation, as it is a better document that addresses the issues that were found in the earlier version.

The problems in the EC with the implementation of the MDR and IVDR continue with things like the lack of agreement on Harmonization, the lack of sufficient Notified Bodies and the lack of auditors and other experts within the Notified Bodies to support all product types.  Just because a Notified Body is appointed doesn't mean they can certify all device types, their certification must identify the types of devices they can support.  Then their are other aspects, like Eudamed that are necessary to complete the process for the manufacturer.

I fear that the EC may release a lot of the elements right before the "drop dead date", and declare the process complete and question why that devices are not available in the EU.  Much like the furor over Brexit and the warnings being issued that there will be a drug shortage, the EC issued warnings in the summer to hospitals about the expected shortage of medical devices.  This has not been widely reported, but is expected to happen.

2. The standard, ISO 14971 and the technical report, ISO TR 24971 are to be released together or within days of each other, as it will be vital because of the reorganization of the two to have them together. That was the focus of the efforts of the Joint Working Group in the last few months, to synchronize the release of the two documents.  The new technical report is over 100 pages, where the standard previously had 68 pages of informative annexes.  There are a few pages of the original informative annexes still in the standard, so you can see the amount of work that has been done to improve the risk management guidance without major revisions to the requirements.  The requirements page count is still about 15 pages.  But, for instance the production / post-production requirements went from a few paragraphs to 2 pages of requirements, and the supporting guidance in the technical report went from 1 page to 10 pages.  That aspect of the risk management process had lots of input from the regulators, like FDA to better explain the process.   

Ed,

Thank you for this exciting news. Could you clarify a few things for me?

Will CEN publish 14971 without Annex ZA to ZE from the FDIS? Does CEN intend to add their own annexes? I infer that when CEN publishes, it will have been standardized but not harmonized.

The forecast for publication is December 2019. Is this for 14971, 24971, or both? It would be great if they came out together.

Richard,

I have not yet done a side by side comparison with the DIS and the EU-MDR. However, there is one area where there seems to be a difference.

The requirements to disclose residual risks is now one requirement after the evaluation of the overall residual risk.

Clause 8 says, "If the overall residual risk is judged acceptable, the manufacturer shall decide which residual risks to disclose …" I infer that the manufacturer may make a disclosure decision on each individual residual risk as well as the overall residual risk.

EU-MDR Annex I(4) says, "Manufacturers shall inform users of any residual risks".

I infer this overturn's the manufacturer's ability to make the decision. In the EU-MDR disclosure is mandatory, not optional.

I'm in great hope that Annex I(4)(c) will prevent the NBs from confusing information for safety with disclosure of residual risk.

In response to your questions Dan:

1.  There will be no Z Annexes due to the lack of agreement in the EC over a harmonization process within the MDR and IVDR.  The presently published "Harmonized" standards are not harmonized to the MDR and IVDR (only to the directives) so they have no status to support the new regulatory requirements in those documents.  Presently the manufacturer is "one his own" to demonstrate compliance with the new regulations, and may develop their own tables to show how their quality system meets those requirements.  CEN will not publish Z Annexes with the standard, it will look exactly like the ISO version with no deviations, just as AAMI does with the US versions of standards.  The new EN ISO 14971:2019 should replace the EN ISO 14971:2012 immediately, in my estimation, as it is a better document that addresses the issues that were found in the earlier version.

The problems in the EC with the implementation of the MDR and IVDR continue with things like the lack of agreement on Harmonization, the lack of sufficient Notified Bodies and the lack of auditors and other experts within the Notified Bodies to support all product types.  Just because a Notified Body is appointed doesn't mean they can certify all device types, their certification must identify the types of devices they can support.  Then their are other aspects, like Eudamed that are necessary to complete the process for the manufacturer.

I fear that the EC may release a lot of the elements right before the "drop dead date", and declare the process complete and question why that devices are not available in the EU.  Much like the furor over Brexit and the warnings being issued that there will be a drug shortage, the EC issued warnings in the summer to hospitals about the expected shortage of medical devices.  This has not been widely reported, but is expected to happen.

2. The standard, ISO 14971 and the technical report, ISO TR 24971 are to be released together or within days of each other, as it will be vital because of the reorganization of the two to have them together. That was the focus of the efforts of the Joint Working Group in the last few months, to synchronize the release of the two documents.  The new technical report is over 100 pages, where the standard previously had 68 pages of informative annexes.  There are a few pages of the original informative annexes still in the standard, so you can see the amount of work that has been done to improve the risk management guidance without major revisions to the requirements.  The requirements page count is still about 15 pages.  But, for instance the production / post-production requirements went from a few paragraphs to 2 pages of requirements, and the supporting guidance in the technical report went from 1 page to 10 pages.  That aspect of the risk management process had lots of input from the regulators, like FDA to better explain the process.   

Ed,

Thank you for this exciting news. Could you clarify a few things for me?

Will CEN publish 14971 without Annex ZA to ZE from the FDIS? Does CEN intend to add their own annexes? I infer that when CEN publishes, it will have been standardized but not harmonized.

The forecast for publication is December 2019. Is this for 14971, 24971, or both? It would be great if they came out together.

Richard,

I have not yet done a side by side comparison with the DIS and the EU-MDR. However, there is one area where there seems to be a difference.

The requirements to disclose residual risks is now one requirement after the evaluation of the overall residual risk.

Clause 8 says, "If the overall residual risk is judged acceptable, the manufacturer shall decide which residual risks to disclose …" I infer that the manufacturer may make a disclosure decision on each individual residual risk as well as the overall residual risk.

EU-MDR Annex I(4) says, "Manufacturers shall inform users of any residual risks".

I infer this overturn's the manufacturer's ability to make the decision. In the EU-MDR disclosure is mandatory, not optional.

I'm in great hope that Annex I(4)(c) will prevent the NBs from confusing information for safety with disclosure of residual risk.

In response to your questions Dan:

1.  There will be no Z Annexes due to the lack of agreement in the EC over a harmonization process within the MDR and IVDR.  The presently published "Harmonized" standards are not harmonized to the MDR and IVDR (only to the directives) so they have no status to support the new regulatory requirements in those documents.  Presently the manufacturer is "one his own" to demonstrate compliance with the new regulations, and may develop their own tables to show how their quality system meets those requirements.  CEN will not publish Z Annexes with the standard, it will look exactly like the ISO version with no deviations, just as AAMI does with the US versions of standards.  The new EN ISO 14971:2019 should replace the EN ISO 14971:2012 immediately, in my estimation, as it is a better document that addresses the issues that were found in the earlier version.

The problems in the EC with the implementation of the MDR and IVDR continue with things like the lack of agreement on Harmonization, the lack of sufficient Notified Bodies and the lack of auditors and other experts within the Notified Bodies to support all product types.  Just because a Notified Body is appointed doesn't mean they can certify all device types, their certification must identify the types of devices they can support.  Then their are other aspects, like Eudamed that are necessary to complete the process for the manufacturer.

I fear that the EC may release a lot of the elements right before the "drop dead date", and declare the process complete and question why that devices are not available in the EU.  Much like the furor over Brexit and the warnings being issued that there will be a drug shortage, the EC issued warnings in the summer to hospitals about the expected shortage of medical devices.  This has not been widely reported, but is expected to happen.

2. The standard, ISO 14971 and the technical report, ISO TR 24971 are to be released together or within days of each other, as it will be vital because of the reorganization of the two to have them together. That was the focus of the efforts of the Joint Working Group in the last few months, to synchronize the release of the two documents.  The new technical report is over 100 pages, where the standard previously had 68 pages of informative annexes.  There are a few pages of the original informative annexes still in the standard, so you can see the amount of work that has been done to improve the risk management guidance without major revisions to the requirements.  The requirements page count is still about 15 pages.  But, for instance the production / post-production requirements went from a few paragraphs to 2 pages of requirements, and the supporting guidance in the technical report went from 1 page to 10 pages.  That aspect of the risk management process had lots of input from the regulators, like FDA to better explain the process.   

Ed,

Thank you for this exciting news. Could you clarify a few things for me?

Will CEN publish 14971 without Annex ZA to ZE from the FDIS? Does CEN intend to add their own annexes? I infer that when CEN publishes, it will have been standardized but not harmonized.

The forecast for publication is December 2019. Is this for 14971, 24971, or both? It would be great if they came out together.

Richard,

I have not yet done a side by side comparison with the DIS and the EU-MDR. However, there is one area where there seems to be a difference.

The requirements to disclose residual risks is now one requirement after the evaluation of the overall residual risk.

Clause 8 says, "If the overall residual risk is judged acceptable, the manufacturer shall decide which residual risks to disclose …" I infer that the manufacturer may make a disclosure decision on each individual residual risk as well as the overall residual risk.

EU-MDR Annex I(4) says, "Manufacturers shall inform users of any residual risks".

I infer this overturn's the manufacturer's ability to make the decision. In the EU-MDR disclosure is mandatory, not optional.

I'm in great hope that Annex I(4)(c) will prevent the NBs from confusing information for safety with disclosure of residual risk.

In response to your questions Dan:

1.  There will be no Z Annexes due to the lack of agreement in the EC over a harmonization process within the MDR and IVDR.  The presently published "Harmonized" standards are not harmonized to the MDR and IVDR (only to the directives) so they have no status to support the new regulatory requirements in those documents.  Presently the manufacturer is "one his own" to demonstrate compliance with the new regulations, and may develop their own tables to show how their quality system meets those requirements.  CEN will not publish Z Annexes with the standard, it will look exactly like the ISO version with no deviations, just as AAMI does with the US versions of standards.  The new EN ISO 14971:2019 should replace the EN ISO 14971:2012 immediately, in my estimation, as it is a better document that addresses the issues that were found in the earlier version.

The problems in the EC with the implementation of the MDR and IVDR continue with things like the lack of agreement on Harmonization, the lack of sufficient Notified Bodies and the lack of auditors and other experts within the Notified Bodies to support all product types.  Just because a Notified Body is appointed doesn't mean they can certify all device types, their certification must identify the types of devices they can support.  Then their are other aspects, like Eudamed that are necessary to complete the process for the manufacturer.

I fear that the EC may release a lot of the elements right before the "drop dead date", and declare the process complete and question why that devices are not available in the EU.  Much like the furor over Brexit and the warnings being issued that there will be a drug shortage, the EC issued warnings in the summer to hospitals about the expected shortage of medical devices.  This has not been widely reported, but is expected to happen.

2. The standard, ISO 14971 and the technical report, ISO TR 24971 are to be released together or within days of each other, as it will be vital because of the reorganization of the two to have them together. That was the focus of the efforts of the Joint Working Group in the last few months, to synchronize the release of the two documents.  The new technical report is over 100 pages, where the standard previously had 68 pages of informative annexes.  There are a few pages of the original informative annexes still in the standard, so you can see the amount of work that has been done to improve the risk management guidance without major revisions to the requirements.  The requirements page count is still about 15 pages.  But, for instance the production / post-production requirements went from a few paragraphs to 2 pages of requirements, and the supporting guidance in the technical report went from 1 page to 10 pages.  That aspect of the risk management process had lots of input from the regulators, like FDA to better explain the process.   

Ed,

Thank you for this exciting news. Could you clarify a few things for me?

Will CEN publish 14971 without Annex ZA to ZE from the FDIS? Does CEN intend to add their own annexes? I infer that when CEN publishes, it will have been standardized but not harmonized.

The forecast for publication is December 2019. Is this for 14971, 24971, or both? It would be great if they came out together.

Richard,

I have not yet done a side by side comparison with the DIS and the EU-MDR. However, there is one area where there seems to be a difference.

The requirements to disclose residual risks is now one requirement after the evaluation of the overall residual risk.

Clause 8 says, "If the overall residual risk is judged acceptable, the manufacturer shall decide which residual risks to disclose …" I infer that the manufacturer may make a disclosure decision on each individual residual risk as well as the overall residual risk.

EU-MDR Annex I(4) says, "Manufacturers shall inform users of any residual risks".

I infer this overturn's the manufacturer's ability to make the decision. In the EU-MDR disclosure is mandatory, not optional.

I'm in great hope that Annex I(4)(c) will prevent the NBs from confusing information for safety with disclosure of residual risk.

In response to your questions Dan:

1.  There will be no Z Annexes due to the lack of agreement in the EC over a harmonization process within the MDR and IVDR.  The presently published "Harmonized" standards are not harmonized to the MDR and IVDR (only to the directives) so they have no status to support the new regulatory requirements in those documents.  Presently the manufacturer is "one his own" to demonstrate compliance with the new regulations, and may develop their own tables to show how their quality system meets those requirements.  CEN will not publish Z Annexes with the standard, it will look exactly like the ISO version with no deviations, just as AAMI does with the US versions of standards.  The new EN ISO 14971:2019 should replace the EN ISO 14971:2012 immediately, in my estimation, as it is a better document that addresses the issues that were found in the earlier version.

The problems in the EC with the implementation of the MDR and IVDR continue with things like the lack of agreement on Harmonization, the lack of sufficient Notified Bodies and the lack of auditors and other experts within the Notified Bodies to support all product types.  Just because a Notified Body is appointed doesn't mean they can certify all device types, their certification must identify the types of devices they can support.  Then their are other aspects, like Eudamed that are necessary to complete the process for the manufacturer.

I fear that the EC may release a lot of the elements right before the "drop dead date", and declare the process complete and question why that devices are not available in the EU.  Much like the furor over Brexit and the warnings being issued that there will be a drug shortage, the EC issued warnings in the summer to hospitals about the expected shortage of medical devices.  This has not been widely reported, but is expected to happen.

2. The standard, ISO 14971 and the technical report, ISO TR 24971 are to be released together or within days of each other, as it will be vital because of the reorganization of the two to have them together. That was the focus of the efforts of the Joint Working Group in the last few months, to synchronize the release of the two documents.  The new technical report is over 100 pages, where the standard previously had 68 pages of informative annexes.  There are a few pages of the original informative annexes still in the standard, so you can see the amount of work that has been done to improve the risk management guidance without major revisions to the requirements.  The requirements page count is still about 15 pages.  But, for instance the production / post-production requirements went from a few paragraphs to 2 pages of requirements, and the supporting guidance in the technical report went from 1 page to 10 pages.  That aspect of the risk management process had lots of input from the regulators, like FDA to better explain the process.   

Ed,

Thank you for this exciting news. Could you clarify a few things for me?

Will CEN publish 14971 without Annex ZA to ZE from the FDIS? Does CEN intend to add their own annexes? I infer that when CEN publishes, it will have been standardized but not harmonized.

The forecast for publication is December 2019. Is this for 14971, 24971, or both? It would be great if they came out together.

Richard,

I have not yet done a side by side comparison with the DIS and the EU-MDR. However, there is one area where there seems to be a difference.

The requirements to disclose residual risks is now one requirement after the evaluation of the overall residual risk.

Clause 8 says, "If the overall residual risk is judged acceptable, the manufacturer shall decide which residual risks to disclose …" I infer that the manufacturer may make a disclosure decision on each individual residual risk as well as the overall residual risk.

EU-MDR Annex I(4) says, "Manufacturers shall inform users of any residual risks".

I infer this overturn's the manufacturer's ability to make the decision. In the EU-MDR disclosure is mandatory, not optional.

I'm in great hope that Annex I(4)(c) will prevent the NBs from confusing information for safety with disclosure of residual risk.

In response to your questions Dan:

1.  There will be no Z Annexes due to the lack of agreement in the EC over a harmonization process within the MDR and IVDR.  The presently published "Harmonized" standards are not harmonized to the MDR and IVDR (only to the directives) so they have no status to support the new regulatory requirements in those documents.  Presently the manufacturer is "one his own" to demonstrate compliance with the new regulations, and may develop their own tables to show how their quality system meets those requirements.  CEN will not publish Z Annexes with the standard, it will look exactly like the ISO version with no deviations, just as AAMI does with the US versions of standards.  The new EN ISO 14971:2019 should replace the EN ISO 14971:2012 immediately, in my estimation, as it is a better document that addresses the issues that were found in the earlier version.

The problems in the EC with the implementation of the MDR and IVDR continue with things like the lack of agreement on Harmonization, the lack of sufficient Notified Bodies and the lack of auditors and other experts within the Notified Bodies to support all product types.  Just because a Notified Body is appointed doesn't mean they can certify all device types, their certification must identify the types of devices they can support.  Then their are other aspects, like Eudamed that are necessary to complete the process for the manufacturer.

I fear that the EC may release a lot of the elements right before the "drop dead date", and declare the process complete and question why that devices are not available in the EU.  Much like the furor over Brexit and the warnings being issued that there will be a drug shortage, the EC issued warnings in the summer to hospitals about the expected shortage of medical devices.  This has not been widely reported, but is expected to happen.

2. The standard, ISO 14971 and the technical report, ISO TR 24971 are to be released together or within days of each other, as it will be vital because of the reorganization of the two to have them together. That was the focus of the efforts of the Joint Working Group in the last few months, to synchronize the release of the two documents.  The new technical report is over 100 pages, where the standard previously had 68 pages of informative annexes.  There are a few pages of the original informative annexes still in the standard, so you can see the amount of work that has been done to improve the risk management guidance without major revisions to the requirements.  The requirements page count is still about 15 pages.  But, for instance the production / post-production requirements went from a few paragraphs to 2 pages of requirements, and the supporting guidance in the technical report went from 1 page to 10 pages.  That aspect of the risk management process had lots of input from the regulators, like FDA to better explain the process.   

Ed,

Thank you for this exciting news. Could you clarify a few things for me?

Will CEN publish 14971 without Annex ZA to ZE from the FDIS? Does CEN intend to add their own annexes? I infer that when CEN publishes, it will have been standardized but not harmonized.

The forecast for publication is December 2019. Is this for 14971, 24971, or both? It would be great if they came out together.

Richard,

I have not yet done a side by side comparison with the DIS and the EU-MDR. However, there is one area where there seems to be a difference.

The requirements to disclose residual risks is now one requirement after the evaluation of the overall residual risk.

Clause 8 says, "If the overall residual risk is judged acceptable, the manufacturer shall decide which residual risks to disclose …" I infer that the manufacturer may make a disclosure decision on each individual residual risk as well as the overall residual risk.

EU-MDR Annex I(4) says, "Manufacturers shall inform users of any residual risks".

I infer this overturn's the manufacturer's ability to make the decision. In the EU-MDR disclosure is mandatory, not optional.

I'm in great hope that Annex I(4)(c) will prevent the NBs from confusing information for safety with disclosure of residual risk.

In response to your questions Dan:

1.  There will be no Z Annexes due to the lack of agreement in the EC over a harmonization process within the MDR and IVDR.  The presently published "Harmonized" standards are not harmonized to the MDR and IVDR (only to the directives) so they have no status to support the new regulatory requirements in those documents.  Presently the manufacturer is "one his own" to demonstrate compliance with the new regulations, and may develop their own tables to show how their quality system meets those requirements.  CEN will not publish Z Annexes with the standard, it will look exactly like the ISO version with no deviations, just as AAMI does with the US versions of standards.  The new EN ISO 14971:2019 should replace the EN ISO 14971:2012 immediately, in my estimation, as it is a better document that addresses the issues that were found in the earlier version.

The problems in the EC with the implementation of the MDR and IVDR continue with things like the lack of agreement on Harmonization, the lack of sufficient Notified Bodies and the lack of auditors and other experts within the Notified Bodies to support all product types.  Just because a Notified Body is appointed doesn't mean they can certify all device types, their certification must identify the types of devices they can support.  Then their are other aspects, like Eudamed that are necessary to complete the process for the manufacturer.

I fear that the EC may release a lot of the elements right before the "drop dead date", and declare the process complete and question why that devices are not available in the EU.  Much like the furor over Brexit and the warnings being issued that there will be a drug shortage, the EC issued warnings in the summer to hospitals about the expected shortage of medical devices.  This has not been widely reported, but is expected to happen.

2. The standard, ISO 14971 and the technical report, ISO TR 24971 are to be released together or within days of each other, as it will be vital because of the reorganization of the two to have them together. That was the focus of the efforts of the Joint Working Group in the last few months, to synchronize the release of the two documents.  The new technical report is over 100 pages, where the standard previously had 68 pages of informative annexes.  There are a few pages of the original informative annexes still in the standard, so you can see the amount of work that has been done to improve the risk management guidance without major revisions to the requirements.  The requirements page count is still about 15 pages.  But, for instance the production / post-production requirements went from a few paragraphs to 2 pages of requirements, and the supporting guidance in the technical report went from 1 page to 10 pages.  That aspect of the risk management process had lots of input from the regulators, like FDA to better explain the process.   

Ed,

Thank you for this exciting news. Could you clarify a few things for me?

Will CEN publish 14971 without Annex ZA to ZE from the FDIS? Does CEN intend to add their own annexes? I infer that when CEN publishes, it will have been standardized but not harmonized.

The forecast for publication is December 2019. Is this for 14971, 24971, or both? It would be great if they came out together.

Richard,

I have not yet done a side by side comparison with the DIS and the EU-MDR. However, there is one area where there seems to be a difference.

The requirements to disclose residual risks is now one requirement after the evaluation of the overall residual risk.

Clause 8 says, "If the overall residual risk is judged acceptable, the manufacturer shall decide which residual risks to disclose …" I infer that the manufacturer may make a disclosure decision on each individual residual risk as well as the overall residual risk.

EU-MDR Annex I(4) says, "Manufacturers shall inform users of any residual risks".

I infer this overturn's the manufacturer's ability to make the decision. In the EU-MDR disclosure is mandatory, not optional.

I'm in great hope that Annex I(4)(c) will prevent the NBs from confusing information for safety with disclosure of residual risk.

In response to your questions Dan:

1.  There will be no Z Annexes due to the lack of agreement in the EC over a harmonization process within the MDR and IVDR.  The presently published "Harmonized" standards are not harmonized to the MDR and IVDR (only to the directives) so they have no status to support the new regulatory requirements in those documents.  Presently the manufacturer is "one his own" to demonstrate compliance with the new regulations, and may develop their own tables to show how their quality system meets those requirements.  CEN will not publish Z Annexes with the standard, it will look exactly like the ISO version with no deviations, just as AAMI does with the US versions of standards.  The new EN ISO 14971:2019 should replace the EN ISO 14971:2012 immediately, in my estimation, as it is a better document that addresses the issues that were found in the earlier version.

The problems in the EC with the implementation of the MDR and IVDR continue with things like the lack of agreement on Harmonization, the lack of sufficient Notified Bodies and the lack of auditors and other experts within the Notified Bodies to support all product types.  Just because a Notified Body is appointed doesn't mean they can certify all device types, their certification must identify the types of devices they can support.  Then their are other aspects, like Eudamed that are necessary to complete the process for the manufacturer.

I fear that the EC may release a lot of the elements right before the "drop dead date", and declare the process complete and question why that devices are not available in the EU.  Much like the furor over Brexit and the warnings being issued that there will be a drug shortage, the EC issued warnings in the summer to hospitals about the expected shortage of medical devices.  This has not been widely reported, but is expected to happen.

2. The standard, ISO 14971 and the technical report, ISO TR 24971 are to be released together or within days of each other, as it will be vital because of the reorganization of the two to have them together. That was the focus of the efforts of the Joint Working Group in the last few months, to synchronize the release of the two documents.  The new technical report is over 100 pages, where the standard previously had 68 pages of informative annexes.  There are a few pages of the original informative annexes still in the standard, so you can see the amount of work that has been done to improve the risk management guidance without major revisions to the requirements.  The requirements page count is still about 15 pages.  But, for instance the production / post-production requirements went from a few paragraphs to 2 pages of requirements, and the supporting guidance in the technical report went from 1 page to 10 pages.  That aspect of the risk management process had lots of input from the regulators, like FDA to better explain the process.   

Ed,

Thank you for this exciting news. Could you clarify a few things for me?

Will CEN publish 14971 without Annex ZA to ZE from the FDIS? Does CEN intend to add their own annexes? I infer that when CEN publishes, it will have been standardized but not harmonized.

The forecast for publication is December 2019. Is this for 14971, 24971, or both? It would be great if they came out together.