Regulatory Open Forum

From what I have understand based on the NSAI white paper (what was sent to clients) they basically say that if there is no current Harmonized Standards then you can use a current standard (EN, EN ISO, ISO, IEC, ASTM, etc.) that has been published more than year prior than should meet that standard if considered the State of Art standard.  Basically you have a year transition period to deal with State of the Art.  Is that what most other Notified Bodies are doing from what those out there know or have heard? 

Just trying to confirm understanding out there.

Thx much,

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Hi Leonard, it's certainly not a general rule. I've seen other notified bodies state explicitly that you will always need to have rationale about why an unharmonised standard is state of art for the GSPR against which the manufacturer claims compliance. It's important to keep in mind that there is a legal gap between international standards as published and EU harmonized standards as harmonised (with the famous Z annexes), and you cannot cannot just assume that the Z gap is not there. This is one of the core problems in EU harmonisation for medical devices at the moment: the EU wants technical harmonisation results to basically fit its legislation, and the international harmonisation system does not work that way (is what the harmonisation organisations say).

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 22-Oct-2020 20:24
From: Leonard Eisner
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

From what I have understand based on the NSAI white paper (what was sent to clients) they basically say that if there is no current Harmonized Standards then you can use a current standard (EN, EN ISO, ISO, IEC, ASTM, etc.) that has been published more than year prior than should meet that standard if considered the State of Art standard.  Basically you have a year transition period to deal with State of the Art.  Is that what most other Notified Bodies are doing from what those out there know or have heard?

Just trying to confirm understanding out there.

Thx much,

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Eric, Leonard,

for particular questions: I would, via the notified body,  reach out to the standardization bodies (CEN, CEMELEC) and try to get access to the list of standards planed for MDR/IVDR harmonisation. With reference to this list (to my knowledge and unfortunately not published to the general audience); I would select the standard versions to be applied.
At the other hand, I would not use the the outdated list of MDD harmonized standards to discuss (nor argue about) with the notified body.

------------------------------
Uwe Zeller | Regulatory Affairs / Risk Management Consultant
Biberach an der Riß, Germany
------------------------------

Original Message:
Sent: 22-Oct-2020 20:24
From: Leonard Eisner
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

From what I have understand based on the NSAI white paper (what was sent to clients) they basically say that if there is no current Harmonized Standards then you can use a current standard (EN, EN ISO, ISO, IEC, ASTM, etc.) that has been published more than year prior than should meet that standard if considered the State of Art standard.  Basically you have a year transition period to deal with State of the Art.  Is that what most other Notified Bodies are doing from what those out there know or have heard?

Just trying to confirm understanding out there.

Thx much,

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Hi all,

I am very interested to hear about this topic because it is so confusing currently.  Thanks for bringing up this point Leo to understand what other Notified Bodies are doing or expecting.  It is very sad the Notified Bodies are not on the same page, and even more sad situation the EC Commission can not implement a standardised method (no pun intended) for how standards should be applied to medical devices and IVDs in relation to the regulation.

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

Original Message:
Sent: 23-Oct-2020 03:09
From: Uwe Zeller
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

Eric, Leonard,

for particular questions: I would, via the notified body,  reach out to the standardization bodies (CEN, CEMELEC) and try to get access to the list of standards planed for MDR/IVDR harmonisation. With reference to this list (to my knowledge and unfortunately not published to the general audience); I would select the standard versions to be applied.
At the other hand, I would not use the the outdated list of MDD harmonized standards to discuss (nor argue about) with the notified body.

------------------------------
Uwe Zeller | Regulatory Affairs / Risk Management Consultant
Biberach an der Riß, Germany

Original Message:
Sent: 22-Oct-2020 20:24
From: Leonard Eisner
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

From what I have understand based on the NSAI white paper (what was sent to clients) they basically say that if there is no current Harmonized Standards then you can use a current standard (EN, EN ISO, ISO, IEC, ASTM, etc.) that has been published more than year prior than should meet that standard if considered the State of Art standard.  Basically you have a year transition period to deal with State of the Art.  Is that what most other Notified Bodies are doing from what those out there know or have heard?

Just trying to confirm understanding out there.

Thx much,

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Hi Uwe, indeed - that's what the notified bodies themselves recommend too. The list of standards intended for MDR and IVDR is public to an extent, because you can see it in the rejected harmonization request although that list is somewhat debated. Still, it gives you a good idea of the standards that the Commission thinks should be in there. You can download the request from my blog: https://medicaldeviceslegal.com/2020/06/20/standardisation-request-for-mdr-and-ivdr-refused-now-what/

That blog also discusses what's going to happen with the request. Since that blog there basically have been no noteworthy new developments: the Commission is still working on the new request and industry should not expect the harmonization process to be finished before the date of application of the MDR, because the harmonization process will also take time. 

Best,
Erik

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 23-Oct-2020 03:09
From: Uwe Zeller
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

Eric, Leonard,

for particular questions: I would, via the notified body,  reach out to the standardization bodies (CEN, CEMELEC) and try to get access to the list of standards planed for MDR/IVDR harmonisation. With reference to this list (to my knowledge and unfortunately not published to the general audience); I would select the standard versions to be applied.
At the other hand, I would not use the the outdated list of MDD harmonized standards to discuss (nor argue about) with the notified body.

------------------------------
Uwe Zeller | Regulatory Affairs / Risk Management Consultant
Biberach an der Riß, Germany

Original Message:
Sent: 22-Oct-2020 20:24
From: Leonard Eisner
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

From what I have understand based on the NSAI white paper (what was sent to clients) they basically say that if there is no current Harmonized Standards then you can use a current standard (EN, EN ISO, ISO, IEC, ASTM, etc.) that has been published more than year prior than should meet that standard if considered the State of Art standard.  Basically you have a year transition period to deal with State of the Art.  Is that what most other Notified Bodies are doing from what those out there know or have heard?

Just trying to confirm understanding out there.

Thx much,

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Hi Erik, Richard, Leonard, 

thank you for pointing us to your blog.
Within my DIN/DKE acitivities;  I have seen a few versions of the list as internal document which should not be posted :-(

There is another source of  related information: the German BMWi published a legal opinion which might provide some background why the harmonisation process is somewhat different as in the past. Here is the link.

------------------------------
Uwe Zeller | Regulatory Affairs / Risk Management Consultant
Biberach an der Riß, Germany
------------------------------

Original Message:
Sent: 23-Oct-2020 03:54
From: Erik Vollebregt
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

Hi Uwe, indeed - that's what the notified bodies themselves recommend too. The list of standards intended for MDR and IVDR is public to an extent, because you can see it in the rejected harmonization request although that list is somewhat debated. Still, it gives you a good idea of the standards that the Commission thinks should be in there. You can download the request from my blog: https://medicaldeviceslegal.com/2020/06/20/standardisation-request-for-mdr-and-ivdr-refused-now-what/

That blog also discusses what's going to happen with the request. Since that blog there basically have been no noteworthy new developments: the Commission is still working on the new request and industry should not expect the harmonization process to be finished before the date of application of the MDR, because the harmonization process will also take time.

Best,
Erik

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 23-Oct-2020 03:09
From: Uwe Zeller
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

Eric, Leonard,

for particular questions: I would, via the notified body,  reach out to the standardization bodies (CEN, CEMELEC) and try to get access to the list of standards planed for MDR/IVDR harmonisation. With reference to this list (to my knowledge and unfortunately not published to the general audience); I would select the standard versions to be applied.
At the other hand, I would not use the the outdated list of MDD harmonized standards to discuss (nor argue about) with the notified body.

------------------------------
Uwe Zeller | Regulatory Affairs / Risk Management Consultant
Biberach an der Riß, Germany

Original Message:
Sent: 22-Oct-2020 20:24
From: Leonard Eisner
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

From what I have understand based on the NSAI white paper (what was sent to clients) they basically say that if there is no current Harmonized Standards then you can use a current standard (EN, EN ISO, ISO, IEC, ASTM, etc.) that has been published more than year prior than should meet that standard if considered the State of Art standard.  Basically you have a year transition period to deal with State of the Art.  Is that what most other Notified Bodies are doing from what those out there know or have heard?

Just trying to confirm understanding out there.

Thx much,

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

BSI Compliance Navigator has a statement that says EN ISO 14971:2019 is the "state of the art" medical device risk management standard.  I know CEN has EN ISO 14971:2012 marked as "Withdrawn" on their website.  Of course, there are no Harmonized standards yet for MDR and IVDR which makes compliance a negotiation between the manufacturer and the Notified Body.  So you have to know what the Notified Body expects to be able to do that.

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

Original Message:
Sent: 22-Oct-2020 20:24
From: Leonard Eisner
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

From what I have understand based on the NSAI white paper (what was sent to clients) they basically say that if there is no current Harmonized Standards then you can use a current standard (EN, EN ISO, ISO, IEC, ASTM, etc.) that has been published more than year prior than should meet that standard if considered the State of Art standard.  Basically you have a year transition period to deal with State of the Art.  Is that what most other Notified Bodies are doing from what those out there know or have heard?

Just trying to confirm understanding out there.

Thx much,

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Hi,

Same approach, ie most recent revision of standards is considered state of the art, is taken by other NBs too (eg TUV SÜD, DEKRA, BSI). GMED is traditionally a very conservative approach and likely prefer compliance to the MDD/AIMDD harmonized standards on the OJ till MDR one is published (which will not happen before early 2021, at best).

------------------------------
Shirley Kadouri
Blonay
Switzerland
------------------------------

Original Message:
Sent: 27-Oct-2020 16:10
From: Edwin Bills
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

BSI Compliance Navigator has a statement that says EN ISO 14971:2019 is the "state of the art" medical device risk management standard.  I know CEN has EN ISO 14971:2012 marked as "Withdrawn" on their website.  Of course, there are no Harmonized standards yet for MDR and IVDR which makes compliance a negotiation between the manufacturer and the Notified Body.  So you have to know what the Notified Body expects to be able to do that.

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

Original Message:
Sent: 22-Oct-2020 20:24
From: Leonard Eisner
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

From what I have understand based on the NSAI white paper (what was sent to clients) they basically say that if there is no current Harmonized Standards then you can use a current standard (EN, EN ISO, ISO, IEC, ASTM, etc.) that has been published more than year prior than should meet that standard if considered the State of Art standard.  Basically you have a year transition period to deal with State of the Art.  Is that what most other Notified Bodies are doing from what those out there know or have heard?

Just trying to confirm understanding out there.

Thx much,

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

The GMED position is not consistent with MDD harmonized standard Commission Implementing Decision (EU) 2020/437, Article 3.

The harmonised standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annexes I and II to this Decision may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/745.

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

Original Message:
Sent: 28-Oct-2020 03:37
From: Shirley Kadouri
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

Hi,

Same approach, ie most recent revision of standards is considered state of the art, is taken by other NBs too (eg TUV SÜD, DEKRA, BSI). GMED is traditionally a very conservative approach and likely prefer compliance to the MDD/AIMDD harmonized standards on the OJ till MDR one is published (which will not happen before early 2021, at best).

------------------------------
Shirley Kadouri
Blonay
Switzerland

Original Message:
Sent: 27-Oct-2020 16:10
From: Edwin Bills
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

BSI Compliance Navigator has a statement that says EN ISO 14971:2019 is the "state of the art" medical device risk management standard.  I know CEN has EN ISO 14971:2012 marked as "Withdrawn" on their website.  Of course, there are no Harmonized standards yet for MDR and IVDR which makes compliance a negotiation between the manufacturer and the Notified Body.  So you have to know what the Notified Body expects to be able to do that.

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

Original Message:
Sent: 22-Oct-2020 20:24
From: Leonard Eisner
Subject: What have you seen for State of the Art Standards Requirements for MDR for BSI DEKRA other NBs in comparison to NSAI

From what I have understand based on the NSAI white paper (what was sent to clients) they basically say that if there is no current Harmonized Standards then you can use a current standard (EN, EN ISO, ISO, IEC, ASTM, etc.) that has been published more than year prior than should meet that standard if considered the State of Art standard.  Basically you have a year transition period to deal with State of the Art.  Is that what most other Notified Bodies are doing from what those out there know or have heard?

Just trying to confirm understanding out there.

Thx much,

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------