Regulatory Open Forum

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition. 

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).  

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Hi Edward,

What a mess! This is a typical example of the situation the manufacturers are facing the last 3 years. Sometimes it feels like we are all heading to a wall.

Regarding the new standard and the TR, unfortunately till May 2021, the 2012 standard is the harmonized one, thus there is no obligation from the manufacturers to follow the 2019 (and as I can see only a few will go with the 2019 version).
Now that there is an official request for harmonization of standards for MDR (which will take at least 6 months), 2019 version of the standard will be harmonized.
But of course it is easier to start now the risk management process with the new version and run the system a whole year in order to be ready as soon as MDR is enforced.

And also I hope the TR will be also harmonized. Because if not, we will also have a problem there

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 21-May-2020 12:41
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition.

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Thanks for the update Edwin !  Looking forward to pressing on with risk management !

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 22-May-2020 02:05
From: Spyros Drivelos
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Hi Edward,

What a mess! This is a typical example of the situation the manufacturers are facing the last 3 years. Sometimes it feels like we are all heading to a wall.

Regarding the new standard and the TR, unfortunately till May 2021, the 2012 standard is the harmonized one, thus there is no obligation from the manufacturers to follow the 2019 (and as I can see only a few will go with the 2019 version).
Now that there is an official request for harmonization of standards for MDR (which will take at least 6 months), 2019 version of the standard will be harmonized.
But of course it is easier to start now the risk management process with the new version and run the system a whole year in order to be ready as soon as MDR is enforced.

And also I hope the TR will be also harmonized. Because if not, we will also have a problem there

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 21-May-2020 12:41
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition.

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Spyros,

Can you give us a link to the official request for harmonization to the EU-MDR?

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 22-May-2020 02:05
From: Spyros Drivelos
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Hi Edward,

What a mess! This is a typical example of the situation the manufacturers are facing the last 3 years. Sometimes it feels like we are all heading to a wall.

Regarding the new standard and the TR, unfortunately till May 2021, the 2012 standard is the harmonized one, thus there is no obligation from the manufacturers to follow the 2019 (and as I can see only a few will go with the 2019 version).
Now that there is an official request for harmonization of standards for MDR (which will take at least 6 months), 2019 version of the standard will be harmonized.
But of course it is easier to start now the risk management process with the new version and run the system a whole year in order to be ready as soon as MDR is enforced.

And also I hope the TR will be also harmonized. Because if not, we will also have a problem there

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 21-May-2020 12:41
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition.

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Hi Dan,

Yes of course. Here you are:
https://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.detail&id=589

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 22-May-2020 08:22
From: Dan O'Leary
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Spyros,

Can you give us a link to the official request for harmonization to the EU-MDR?

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 22-May-2020 02:05
From: Spyros Drivelos
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Hi Edward,

What a mess! This is a typical example of the situation the manufacturers are facing the last 3 years. Sometimes it feels like we are all heading to a wall.

Regarding the new standard and the TR, unfortunately till May 2021, the 2012 standard is the harmonized one, thus there is no obligation from the manufacturers to follow the 2019 (and as I can see only a few will go with the 2019 version).
Now that there is an official request for harmonization of standards for MDR (which will take at least 6 months), 2019 version of the standard will be harmonized.
But of course it is easier to start now the risk management process with the new version and run the system a whole year in order to be ready as soon as MDR is enforced.

And also I hope the TR will be also harmonized. Because if not, we will also have a problem there

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 21-May-2020 12:41
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition.

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Thanks, Spyros. They finally did it. CEN has Withdrawn EN ISO 14971:2012 and replaced it with EN ISO 14971:2019. An Amendment will be issued with updated tables from the FDIS for MDR and IVDR only to meet the required items in the SR.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 22-May-2020 08:27
From: Spyros Drivelos
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Hi Dan,

Yes of course. Here you are:
https://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.detail&id=589

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 22-May-2020 08:22
From: Dan O'Leary
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Spyros,

Can you give us a link to the official request for harmonization to the EU-MDR?

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 22-May-2020 02:05
From: Spyros Drivelos
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Hi Edward,

What a mess! This is a typical example of the situation the manufacturers are facing the last 3 years. Sometimes it feels like we are all heading to a wall.

Regarding the new standard and the TR, unfortunately till May 2021, the 2012 standard is the harmonized one, thus there is no obligation from the manufacturers to follow the 2019 (and as I can see only a few will go with the 2019 version).
Now that there is an official request for harmonization of standards for MDR (which will take at least 6 months), 2019 version of the standard will be harmonized.
But of course it is easier to start now the risk management process with the new version and run the system a whole year in order to be ready as soon as MDR is enforced.

And also I hope the TR will be also harmonized. Because if not, we will also have a problem there

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 21-May-2020 12:41
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition.

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Thank you Sypros for the link.

It is my understanding that harmonization of a standard requires two sequential processes. First, a European Standards Organization, ESO, adopts the standard. Then there is a Commission Implementing Decision that harmonizes the standard. The harmonization implementing decision appears in the Official Journal.

In this case, we have a Commission Implementing Decision asking two ESO, CEN and Cenelec, to start the standardization process. In Annex III, Part A, Section 5 the request asks that each standard include the information on the correspondence between the clauses of the standard and the requirements of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 to cover.

There are two of particular interest to me: 13485 and 14971.

The request asks for standardization of EN ISO 13485:2016+AC:2018 by May 26, 2020. The CEN website shows the current version is EN ISO 13485:2016/AC:2018 with an updated document in progress. I think the update will incorporate the information from CEN/TR 17223:2018.

The request asks for standardization of EN ISO 14971:2012 by May 26, 2020. The CEN website shows the current standard is EN ISO 14981:2019, but not an updated document in progress. Ed Bills pointed out, that there will be a revision that uses updated tables from the ISO FDIS for the two regulations only.

I'm rooting for CEN to meet the target date of May 26, 2020.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 22-May-2020 08:27
From: Spyros Drivelos
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Hi Dan,

Yes of course. Here you are:
https://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.detail&id=589

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 22-May-2020 08:22
From: Dan O'Leary
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Spyros,

Can you give us a link to the official request for harmonization to the EU-MDR?

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 22-May-2020 02:05
From: Spyros Drivelos
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Hi Edward,

What a mess! This is a typical example of the situation the manufacturers are facing the last 3 years. Sometimes it feels like we are all heading to a wall.

Regarding the new standard and the TR, unfortunately till May 2021, the 2012 standard is the harmonized one, thus there is no obligation from the manufacturers to follow the 2019 (and as I can see only a few will go with the 2019 version).
Now that there is an official request for harmonization of standards for MDR (which will take at least 6 months), 2019 version of the standard will be harmonized.
But of course it is easier to start now the risk management process with the new version and run the system a whole year in order to be ready as soon as MDR is enforced.

And also I hope the TR will be also harmonized. Because if not, we will also have a problem there

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 21-May-2020 12:41
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition.

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Spyros,

EN ISO DTR 24971:2020 is not a standard but is a Technical Report, and as such contains no requirements.  24971 only has guidance on implementing EN ISO 14971:2019, so I don't think it would be Harmonized.  The TR just gives information about various ways a company may implement the standard, and does not set the ONLY method for meeting the requirements of the standard.

So, my question is, "Why would 24971 be Harmonized?

Ed

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 22-May-2020 02:05
From: Spyros Drivelos
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Hi Edward,

What a mess! This is a typical example of the situation the manufacturers are facing the last 3 years. Sometimes it feels like we are all heading to a wall.

Regarding the new standard and the TR, unfortunately till May 2021, the 2012 standard is the harmonized one, thus there is no obligation from the manufacturers to follow the 2019 (and as I can see only a few will go with the 2019 version).
Now that there is an official request for harmonization of standards for MDR (which will take at least 6 months), 2019 version of the standard will be harmonized.
But of course it is easier to start now the risk management process with the new version and run the system a whole year in order to be ready as soon as MDR is enforced.

And also I hope the TR will be also harmonized. Because if not, we will also have a problem there

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 21-May-2020 12:41
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition.

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Edwin,

Sorry, I did not properly address my response and question you. Should not be to Bill.

Bob<gdiv></gdiv>

------------------------------
Robert Bard JD, RAC
[Managing Director]
South Lyon MI
United States
------------------------------

Original Message:
Sent: 22-May-2020 10:56
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Spyros,

EN ISO DTR 24971:2020 is not a standard but is a Technical Report, and as such contains no requirements.  24971 only has guidance on implementing EN ISO 14971:2019, so I don't think it would be Harmonized.  The TR just gives information about various ways a company may implement the standard, and does not set the ONLY method for meeting the requirements of the standard.

So, my question is, "Why would 24971 be Harmonized?

Ed

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 22-May-2020 02:05
From: Spyros Drivelos
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Hi Edward,

What a mess! This is a typical example of the situation the manufacturers are facing the last 3 years. Sometimes it feels like we are all heading to a wall.

Regarding the new standard and the TR, unfortunately till May 2021, the 2012 standard is the harmonized one, thus there is no obligation from the manufacturers to follow the 2019 (and as I can see only a few will go with the 2019 version).
Now that there is an official request for harmonization of standards for MDR (which will take at least 6 months), 2019 version of the standard will be harmonized.
But of course it is easier to start now the risk management process with the new version and run the system a whole year in order to be ready as soon as MDR is enforced.

And also I hope the TR will be also harmonized. Because if not, we will also have a problem there

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 21-May-2020 12:41
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition.

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Hi Bill, your comments point out what I thought are significant problems ISO 14971:2019.

1) With EN ISO 14971:2019 really being only a partial document at this time, can we really use 2019? May be just a starting point.

2) 2019 not is not Harmonized to either MDD or MDR (MDD is going to continue for some time for a large number of CE mark devices). Which means, MDD CE mark holders will need to continue using 2012 (2019 does not come into full force until 2022)

3) What happens to EN ISO 14971:2019? Does it become 14971:2020 or 2021 at the cost of another US$400? Should 2019 have been released knowing that it was flawed at best but really incomplete (not functional)?

4) I had been advising client to move to ISO 14971:2019 for new CE mark products; but now, this is looking a redo for MDR conformity assessments.

Your thoughts, Bob




 <gdiv></gdiv>

------------------------------
Robert Bard JD, RAC
[Managing Director]
South Lyon MI
United States
------------------------------

Original Message:
Sent: 21-May-2020 12:41
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition.

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Robert,

Thanks for your questions.  I believe in the old saying, "its not over until it's over!" Remember the EN versions only apply to the EU, and not rest of world.  ISO 14971:2019 applies everywhere else (unless a regulator says otherwise). Until  we have a European Harmonized version published in the Official Journal, we will not have the final answer.  BUT, I think we can proceed cautiously.  

1. The complete ISO FDIS 14971:2019 was published last year with Correspondence Tables which, while not final, are a good basis for starting for European compliance.  In the rest of the world, ISO 14971:2019 as published applies.  

2. The Notified Bodies are proceeding with their own pathways, BSI for one, indicates that EN ISO 14971:2019 is the "state of the art" risk management standard.  

3. CEN has Withdrawn EN ISO 14971:2012 and replaced it with the 2019 version.

4. EN ISO DTR 24971:2020 contains no requirements, it is only guidance (suggestions) on how to implement the standard.  The only requirements for risk management are in (EN) ISO 14971:2019 Clauses 1-10.  Annexes A, B, C are NOT requirements, but only provide information.  Annex A is invaluable in that it is the Rationale for the requirements established in Clauses 1-10, and everyone should read that annex.

5. A draft version of ISO TR 24971:2020 is available from AAMI (as identified elsewhere in this thread).  This version will be released after the CEN / CENELEC voting process is complete, hopefully, mid-June.  At this stage, no changes may be made, except for editorial changes, and so the released document will be the same as the draft version at AAMI's store.  AAMI will give those that purchase this draft document the final released version, at no additional cost.

6.  Pay close attention to establishing a Risk Management Policy and guidance for this requirement.  Also, the Production and Postproduction risk management will require attention, but it complies with the PSUR requirements of the EU regulations.  It also requires active monitoring of product performance, just like the EU regulations, but not everyone has this established.  It is not just monitoring complaints, but seeking information on product performance.  

I am advising that clients immediately proceed with updating their risk management system (new name for Clause 4) to comply with the new standard.  They should establish a Quality Plan for the update process to guide their work. If a development project is just starting (or recently started) use the new standard.  FDA allows use of ISO 14971:2007 (current worldwide version) until December 25, 2022 for all product submissions, but allows 2019 version (3rd Edition) immediately. 

By the way, I answer to either Ed or Bill, it has been that way my whole life.  Stuck with two first names!

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 22-May-2020 10:56
From: Robert Bard
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Hi Bill, your comments point out what I thought are significant problems ISO 14971:2019.

1) With EN ISO 14971:2019 really being only a partial document at this time, can we really use 2019? May be just a starting point.

2) 2019 not is not Harmonized to either MDD or MDR (MDD is going to continue for some time for a large number of CE mark devices). Which means, MDD CE mark holders will need to continue using 2012 (2019 does not come into full force until 2022)

3) What happens to EN ISO 14971:2019? Does it become 14971:2020 or 2021 at the cost of another US$400? Should 2019 have been released knowing that it was flawed at best but really incomplete (not functional)?

4) I had been advising client to move to ISO 14971:2019 for new CE mark products; but now, this is looking a redo for MDR conformity assessments.

Your thoughts, Bob




 <gdiv></gdiv>

------------------------------
Robert Bard JD, RAC
[Managing Director]
South Lyon MI
United States

Original Message:
Sent: 21-May-2020 12:41
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition.

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

I referred to ISO TR 24971:2020 in this message stream.  It was a published in Europe as EN ISO TR 24971:2020 as well as the identical rest-of-world version ISO TR 24971:2020 in June.  Every company using ISO 14971:2019 or its European counterpart, EN ISO 14971:2019 should have copies of this technical report.  It is invaluable in interpreting and applying the requirements of the risk management standard, ISO 14971:2019 or EN ISO 14971:2019 as appropriate.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 22-May-2020 11:39
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Robert,

Thanks for your questions.  I believe in the old saying, "its not over until it's over!" Remember the EN versions only apply to the EU, and not rest of world.  ISO 14971:2019 applies everywhere else (unless a regulator says otherwise). Until  we have a European Harmonized version published in the Official Journal, we will not have the final answer.  BUT, I think we can proceed cautiously.

1. The complete ISO FDIS 14971:2019 was published last year with Correspondence Tables which, while not final, are a good basis for starting for European compliance.  In the rest of the world, ISO 14971:2019 as published applies.

2. The Notified Bodies are proceeding with their own pathways, BSI for one, indicates that EN ISO 14971:2019 is the "state of the art" risk management standard.

3. CEN has Withdrawn EN ISO 14971:2012 and replaced it with the 2019 version.

4. EN ISO DTR 24971:2020 contains no requirements, it is only guidance (suggestions) on how to implement the standard.  The only requirements for risk management are in (EN) ISO 14971:2019 Clauses 1-10.  Annexes A, B, C are NOT requirements, but only provide information.  Annex A is invaluable in that it is the Rationale for the requirements established in Clauses 1-10, and everyone should read that annex.

5. A draft version of ISO TR 24971:2020 is available from AAMI (as identified elsewhere in this thread).  This version will be released after the CEN / CENELEC voting process is complete, hopefully, mid-June.  At this stage, no changes may be made, except for editorial changes, and so the released document will be the same as the draft version at AAMI's store.  AAMI will give those that purchase this draft document the final released version, at no additional cost.

6.  Pay close attention to establishing a Risk Management Policy and guidance for this requirement.  Also, the Production and Postproduction risk management will require attention, but it complies with the PSUR requirements of the EU regulations.  It also requires active monitoring of product performance, just like the EU regulations, but not everyone has this established.  It is not just monitoring complaints, but seeking information on product performance.

I am advising that clients immediately proceed with updating their risk management system (new name for Clause 4) to comply with the new standard.  They should establish a Quality Plan for the update process to guide their work. If a development project is just starting (or recently started) use the new standard.  FDA allows use of ISO 14971:2007 (current worldwide version) until December 25, 2022 for all product submissions, but allows 2019 version (3rd Edition) immediately.

By the way, I answer to either Ed or Bill, it has been that way my whole life.  Stuck with two first names!

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 22-May-2020 10:56
From: Robert Bard
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Hi Bill, your comments point out what I thought are significant problems ISO 14971:2019.

1) With EN ISO 14971:2019 really being only a partial document at this time, can we really use 2019? May be just a starting point.

2) 2019 not is not Harmonized to either MDD or MDR (MDD is going to continue for some time for a large number of CE mark devices). Which means, MDD CE mark holders will need to continue using 2012 (2019 does not come into full force until 2022)

3) What happens to EN ISO 14971:2019? Does it become 14971:2020 or 2021 at the cost of another US$400? Should 2019 have been released knowing that it was flawed at best but really incomplete (not functional)?

4) I had been advising client to move to ISO 14971:2019 for new CE mark products; but now, this is looking a redo for MDR conformity assessments.

Your thoughts, Bob




 <gdiv></gdiv>

------------------------------
Robert Bard JD, RAC
[Managing Director]
South Lyon MI
United States

Original Message:
Sent: 21-May-2020 12:41
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition.

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

To buy the international version of the standard or technical report, go to the ISO web site.

To buy the US versions go to the ANSI website.

To buy the European versions you first need to determine who sells them. In the EU, the standards organization that corresponds to ISO is CEN. Their website has a search engine at https://standards.cen.eu/dyn/www/f?p=204:105:0:::::

In the Standard Reference box enter 14971 and hit search. It will return two standards. Look at the one for risk management, not textiles. Click on the shopping cart icon and you will get a list of the standards organizations that sell EN ISO 14971:2019. The prices are not uniform. Generally, Estonia has the best price. If you buy the document from Estonia it will be EVS-EN ISO 14971:2019.

Go back to the CEN search engine and enter 24971. It will return CEN ISO/TR 24971:2020. Use the shopping cart icon to determine the sales points.

If you have a favorite member state sales point you can start there and skip the CEN step.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 24-Aug-2020 15:04
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

I referred to ISO TR 24971:2020 in this message stream.  It was a published in Europe as EN ISO TR 24971:2020 as well as the identical rest-of-world version ISO TR 24971:2020 in June.  Every company using ISO 14971:2019 or its European counterpart, EN ISO 14971:2019 should have copies of this technical report.  It is invaluable in interpreting and applying the requirements of the risk management standard, ISO 14971:2019 or EN ISO 14971:2019 as appropriate.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 22-May-2020 11:39
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Robert,

Thanks for your questions.  I believe in the old saying, "its not over until it's over!" Remember the EN versions only apply to the EU, and not rest of world.  ISO 14971:2019 applies everywhere else (unless a regulator says otherwise). Until  we have a European Harmonized version published in the Official Journal, we will not have the final answer.  BUT, I think we can proceed cautiously.

1. The complete ISO FDIS 14971:2019 was published last year with Correspondence Tables which, while not final, are a good basis for starting for European compliance.  In the rest of the world, ISO 14971:2019 as published applies.

2. The Notified Bodies are proceeding with their own pathways, BSI for one, indicates that EN ISO 14971:2019 is the "state of the art" risk management standard.

3. CEN has Withdrawn EN ISO 14971:2012 and replaced it with the 2019 version.

4. EN ISO DTR 24971:2020 contains no requirements, it is only guidance (suggestions) on how to implement the standard.  The only requirements for risk management are in (EN) ISO 14971:2019 Clauses 1-10.  Annexes A, B, C are NOT requirements, but only provide information.  Annex A is invaluable in that it is the Rationale for the requirements established in Clauses 1-10, and everyone should read that annex.

5. A draft version of ISO TR 24971:2020 is available from AAMI (as identified elsewhere in this thread).  This version will be released after the CEN / CENELEC voting process is complete, hopefully, mid-June.  At this stage, no changes may be made, except for editorial changes, and so the released document will be the same as the draft version at AAMI's store.  AAMI will give those that purchase this draft document the final released version, at no additional cost.

6.  Pay close attention to establishing a Risk Management Policy and guidance for this requirement.  Also, the Production and Postproduction risk management will require attention, but it complies with the PSUR requirements of the EU regulations.  It also requires active monitoring of product performance, just like the EU regulations, but not everyone has this established.  It is not just monitoring complaints, but seeking information on product performance.

I am advising that clients immediately proceed with updating their risk management system (new name for Clause 4) to comply with the new standard.  They should establish a Quality Plan for the update process to guide their work. If a development project is just starting (or recently started) use the new standard.  FDA allows use of ISO 14971:2007 (current worldwide version) until December 25, 2022 for all product submissions, but allows 2019 version (3rd Edition) immediately.

By the way, I answer to either Ed or Bill, it has been that way my whole life.  Stuck with two first names!

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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 22-May-2020 10:56
From: Robert Bard
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Hi Bill, your comments point out what I thought are significant problems ISO 14971:2019.

1) With EN ISO 14971:2019 really being only a partial document at this time, can we really use 2019? May be just a starting point.

2) 2019 not is not Harmonized to either MDD or MDR (MDD is going to continue for some time for a large number of CE mark devices). Which means, MDD CE mark holders will need to continue using 2012 (2019 does not come into full force until 2022)

3) What happens to EN ISO 14971:2019? Does it become 14971:2020 or 2021 at the cost of another US$400? Should 2019 have been released knowing that it was flawed at best but really incomplete (not functional)?

4) I had been advising client to move to ISO 14971:2019 for new CE mark products; but now, this is looking a redo for MDR conformity assessments.

Your thoughts, Bob




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Robert Bard JD, RAC
[Managing Director]
South Lyon MI
United States

Original Message:
Sent: 21-May-2020 12:41
From: Edwin Bills
Subject: Where can I find ISO TR 24971:2020 and EN ISO TR 24971:2020?

Due to a miscommunication between ISO and CEN, a vote on approving ISO TR 24971 2nd Edition was missed in May 2019.  As a result, a re-vote had to be performed in Europe in March, a 12 week process.  It is anticipated that the new document "may" be released as early as mid-June.  In the meantime, AAMI has a draft version (which is expected to be identical to the final) available at the AAMI Store at AAMI Main Page .  I suspect other standards providers may have the document available.  AAMI states that if you buy the draft, they will send a copy of the final version at no cost to you.  I advise getting it now to begin the update to your processes.

 While FDA will accept submissions in compliance with the 2007 edition until December 25, 2022, it is not guaranteed that other regulators will follow the same process.  In fact, BSI has stated that EN ISO 14971:2019 is the "state of the art" standard for medical device risk management.  State of the art is the preferred standard to be used for compliance.  CEN has Withdrawn the 2012 edition.

In the meantime, users of the ISO 14971:2019 are missing 100 pages of informative annexes that the ISO TC 210 JWG1, authors of ISO 14971:2019 intended to be released at the same time as the standard.  This was because much of the new edition consisted of many annexes moved from the ISO 14971:2007 standard (and no there is not a ISO 14971:2012 standard, the latest international version is 2007).  A total of 51 new pages of informative annexes were released between ISO 14971:2019 and ISO TR 24971:202X (when it is released).

In the EU, the ISO 14971:2019 standard released in parallel with the ISO version was released as an identical document to the ISO version as no harmonization process yet exists for the MDR and IVDR.  When the EC decides to send a Standardization Request to the European Standards body, CEN (and CENELEC) an amended version of the EN standard will be released with Z Annexes (which are informative and not requirements).  It is expected that no Content Deviations will be included due to the new regulations and the revisions to ISO 14971:2019.  There will be Correspondence Tables similar to those released in the FDIS ISO 14971:2019 that became available in May 2019.  Those currently may be useful to those updating their risk management system to the MDR / IVDR, though they are not guaranteed to be final, but very close to the expected amended standard.  EN ISO 14971:2012 is NOT harmonized to the MDR / IVDR, and should not be used in your efforts to achieve compliance to the new regulations.  There are significant differences in the 2012 compared to the new European regulations.

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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
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