Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

My employer who resides in the US has recently decided that they would like to begin CE marking their IVDs which would be under the IVDD until May 2022; all of our products would be self-certified. I have a general knowledge of the IVDD, but have some questions which I would really appreciate answers to:

1) Our QMS is ISO 13485:2016/MDSAP certified, can we leverage this in any way as a means of complying with the essential requirements?

2) We established performance characteristics for many of our products using the CLSI guidelines (FDA recognized consensus standards), can these standards be used to demonstrate compliance with the essential requirements? If not, which standards can be used and where can I find them?

3) Our risk management process conforms with ISO 14971:2007, which I know is not recognized in the EU. Rather than implementing EN 14971:2012 I think it would be smarter to implement ISO 14971:2019, as this is recognized by the FDA and will be replacing 14971:2007. Is ISO 14971:2019 going to be recognized by EU?

Thank you very much.

Good day Anon,

The responses to your questions are a bit far reaching for the content of a forum post.  I would recommend a couple points, maybe reach out to a subject matter expert to understand the specific requirements or maybe attend training sessions and the second point is do not look just at IVDD, look at the EU IVDR now.  Even though the compliance date is May 2022, depending on your IVD product the work towards IVDR should be started now.  In fact, your comment about meeting the Essential Requirements should be geared currently to how you are meeting the General Safety and Performance Requirements.

In answer to your questions:
1. Absolutely.  The ISO 13485 standard describes how to implement a quality management system.  In the EU IVDR there is a requirement for a quality management system which the least burdensome approach is obtaining ISO 13485 certification.
2. There are a couple other ISO standards, but the CLSI standards are some of the main analytical testing methods out there, i.e. sensitivity, specificity, interfering substances, etc.  However, just make sure you describe this clearly in your technical documentation because the CLSI standards are not international standards and certainly are not harmonised to the regulation.
3. Just go forward with EN ISO 14971:2019 that is a released standard and would be state of the art.

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

Original Message:
Sent: 29-Oct-2020 08:30
From: Anonymous Member
Subject: In Vitro Diagnostics CE Marking Under the IVDD

This message was posted by a user wishing to remain anonymous

Hi all,

My employer who resides in the US has recently decided that they would like to begin CE marking their IVDs which would be under the IVDD until May 2022; all of our products would be self-certified. I have a general knowledge of the IVDD, but have some questions which I would really appreciate answers to:

1) Our QMS is ISO 13485:2016/MDSAP certified, can we leverage this in any way as a means of complying with the essential requirements?

2) We established performance characteristics for many of our products using the CLSI guidelines (FDA recognized consensus standards), can these standards be used to demonstrate compliance with the essential requirements? If not, which standards can be used and where can I find them?

3) Our risk management process conforms with ISO 14971:2007, which I know is not recognized in the EU. Rather than implementing EN 14971:2012 I think it would be smarter to implement ISO 14971:2019, as this is recognized by the FDA and will be replacing 14971:2007. Is ISO 14971:2019 going to be recognized by EU?

Thank you very much.

Dear Anon 
I fully agree with Richard his comments.
prepare fully fir the IVDR know; although you still can notify the products as seks declared at an eu country under the ivdd. 

you have to have an EU rep of course in order to notify( not located in the UK!!!)

But prepare for the IVDR; in order to get. Cert under the IVDR before 26 may 2022 you have to Apply at a notified body now. Technical Documentation  reviews take 6-9 Months. And initial audits need to be planned an executed as well. So manufacturers now fully focus on getting the documentation ready asap to apply at a motified body for IVDR Certification. So I fully agree with Richard his remark.
kind regards
Anja Wiersma 
chair board of RAPS Netherlands Chapter

------------------------------
Anja Wiersma
Chair of Board of RAPS Netherlands Chapter, CEO of mi-CE consultancy
Valburg
Netherlands
------------------------------

Original Message:
Sent: 30-Oct-2020 04:50
From: Richard Vincins
Subject: In Vitro Diagnostics CE Marking Under the IVDD

Good day Anon,

The responses to your questions are a bit far reaching for the content of a forum post.  I would recommend a couple points, maybe reach out to a subject matter expert to understand the specific requirements or maybe attend training sessions and the second point is do not look just at IVDD, look at the EU IVDR now.  Even though the compliance date is May 2022, depending on your IVD product the work towards IVDR should be started now.  In fact, your comment about meeting the Essential Requirements should be geared currently to how you are meeting the General Safety and Performance Requirements.

In answer to your questions:
1. Absolutely.  The ISO 13485 standard describes how to implement a quality management system.  In the EU IVDR there is a requirement for a quality management system which the least burdensome approach is obtaining ISO 13485 certification.
2. There are a couple other ISO standards, but the CLSI standards are some of the main analytical testing methods out there, i.e. sensitivity, specificity, interfering substances, etc.  However, just make sure you describe this clearly in your technical documentation because the CLSI standards are not international standards and certainly are not harmonised to the regulation.
3. Just go forward with EN ISO 14971:2019 that is a released standard and would be state of the art.

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

Original Message:
Sent: 29-Oct-2020 08:30
From: Anonymous Member
Subject: In Vitro Diagnostics CE Marking Under the IVDD

This message was posted by a user wishing to remain anonymous

Hi all,

My employer who resides in the US has recently decided that they would like to begin CE marking their IVDs which would be under the IVDD until May 2022; all of our products would be self-certified. I have a general knowledge of the IVDD, but have some questions which I would really appreciate answers to:

1) Our QMS is ISO 13485:2016/MDSAP certified, can we leverage this in any way as a means of complying with the essential requirements?

2) We established performance characteristics for many of our products using the CLSI guidelines (FDA recognized consensus standards), can these standards be used to demonstrate compliance with the essential requirements? If not, which standards can be used and where can I find them?

3) Our risk management process conforms with ISO 14971:2007, which I know is not recognized in the EU. Rather than implementing EN 14971:2012 I think it would be smarter to implement ISO 14971:2019, as this is recognized by the FDA and will be replacing 14971:2007. Is ISO 14971:2019 going to be recognized by EU?

Thank you very much.

Hi Anon,

To answer your questions:
1) Yes, but be sure to add or update QMS procedures to address: a) identifying and meeting IVDD requirements and related regulations, b) vigilance, c) procedures for drawing up IVDD technical documentation and communication responsibilities between you and your Authorized Rep (be sure to qualify the AR under your supplier quality system and put in place a quality agreement with the AR), d) how to handle significant design changes for your CE Marked devices, and e) EU labeling requirements.

2) IVDs meeting CLSI requirements typically comply with IVDD. It is up to you to review the list of EU IVDD harmonized standards and determine those you can use to demonstrate compliance. These are voluntary, but if, for example, you choose to use the harmonized standard for reagent stability you may find that your studies to date fall short of some of the requirements.

3) I agree with Richard that if you are looking to update your risk system, go for the ISO 14971:2019. However, do know that even the new standard does not fully meet IVDD requirements. The IVDD has more strict requirements that are outlined in EN ISO 14971:2012 Annex ZC. Your choices here are to review these Annex ZC requirements against ISO 14971:2019 to see if you can accommodate these in the updated system, or consider (since you are already updating the system) making your updated system comply with IVDR requirements for risk analysis (specifically IVDR Annex I points 1-8). 

I hope this helps!

------------------------------
Christie Hughes MT(ASCP), MPH
Senior Consultant, Qserve Group
Austin, TX
United States
------------------------------

Original Message:
Sent: 29-Oct-2020 08:30
From: Anonymous Member
Subject: In Vitro Diagnostics CE Marking Under the IVDD

This message was posted by a user wishing to remain anonymous

Hi all,

My employer who resides in the US has recently decided that they would like to begin CE marking their IVDs which would be under the IVDD until May 2022; all of our products would be self-certified. I have a general knowledge of the IVDD, but have some questions which I would really appreciate answers to:

1) Our QMS is ISO 13485:2016/MDSAP certified, can we leverage this in any way as a means of complying with the essential requirements?

2) We established performance characteristics for many of our products using the CLSI guidelines (FDA recognized consensus standards), can these standards be used to demonstrate compliance with the essential requirements? If not, which standards can be used and where can I find them?

3) Our risk management process conforms with ISO 14971:2007, which I know is not recognized in the EU. Rather than implementing EN 14971:2012 I think it would be smarter to implement ISO 14971:2019, as this is recognized by the FDA and will be replacing 14971:2007. Is ISO 14971:2019 going to be recognized by EU?

Thank you very much.

------------------------------
Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic
------------------------------

Original Message:
Sent: 29-Oct-2020 08:30
From: Anonymous Member
Subject: In Vitro Diagnostics CE Marking Under the IVDD

This message was posted by a user wishing to remain anonymous

Hi all,

My employer who resides in the US has recently decided that they would like to begin CE marking their IVDs which would be under the IVDD until May 2022; all of our products would be self-certified. I have a general knowledge of the IVDD, but have some questions which I would really appreciate answers to:

1) Our QMS is ISO 13485:2016/MDSAP certified, can we leverage this in any way as a means of complying with the essential requirements?

2) We established performance characteristics for many of our products using the CLSI guidelines (FDA recognized consensus standards), can these standards be used to demonstrate compliance with the essential requirements? If not, which standards can be used and where can I find them?

3) Our risk management process conforms with ISO 14971:2007, which I know is not recognized in the EU. Rather than implementing EN 14971:2012 I think it would be smarter to implement ISO 14971:2019, as this is recognized by the FDA and will be replacing 14971:2007. Is ISO 14971:2019 going to be recognized by EU?

Thank you very much.