Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS 

Should EU Declaration of Conformity contain references to Harmonized standards or only to CS? 

I wonder on this because MDR Annex IV asks only for CS, however Harmonized Standards are normally used  as well to declare conformity. 

Thank you!

You are correct there is not any reference specific to having harmonised standards listed on the Declaration of Conformity (DofC) only with the requirement for CS.  However, in experience over the MDD it is common practice to include many of the main harmonised standards like IEC 60601, IEC 62366, and product specific standards/  Most requirements having standards listed actually comes from individual Notified Bodies when they expect content to contain for the DofC.  Definitely inquire or confirm with your Notified Body content of DofC under the EU MDR as there are some changes from the MDD requirements.

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

Original Message:
Sent: 22-Jul-2019 16:48
From: Anonymous Member
Subject: EU Declaration of Conformity-MDR

This message was posted by a user wishing to remain anonymous

Dear RAPS

Should EU Declaration of Conformity contain references to Harmonized standards or only to CS?

I wonder on this because MDR Annex IV asks only for CS, however Harmonized Standards are normally used  as well to declare conformity.

Thank you!

​I agree with you Richard that under the MDD it was common practice that individual Notified Bodies required to include certain standards on the DoC. A reason for that being that the MDD did not identify what was expected on the DoC, several of the Notified Bodies 'invented' their own requirements and even provided example templates. Now with the MDR I sincerely hope that this common practice will fade away and all parties involved stick to the requirements of Annex IV rather than be led by 'what a Notified Body wants'.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
------------------------------

Original Message:
Sent: 23-Jul-2019 02:32
From: Richard Vincins
Subject: EU Declaration of Conformity-MDR

You are correct there is not any reference specific to having harmonised standards listed on the Declaration of Conformity (DofC) only with the requirement for CS.  However, in experience over the MDD it is common practice to include many of the main harmonised standards like IEC 60601, IEC 62366, and product specific standards/  Most requirements having standards listed actually comes from individual Notified Bodies when they expect content to contain for the DofC.  Definitely inquire or confirm with your Notified Body content of DofC under the EU MDR as there are some changes from the MDD requirements.

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

Original Message:
Sent: 22-Jul-2019 16:48
From: Anonymous Member
Subject: EU Declaration of Conformity-MDR

This message was posted by a user wishing to remain anonymous

Dear RAPS

Should EU Declaration of Conformity contain references to Harmonized standards or only to CS?

I wonder on this because MDR Annex IV asks only for CS, however Harmonized Standards are normally used  as well to declare conformity.

Thank you!

 stick to the requirements of Annex IV rather than be led by 'what a Notified Body wants' ... we can hope Peter ... but I doubt it ...

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

Original Message:
Sent: 23-Jul-2019 03:05
From: Peter Reijntjes
Subject: EU Declaration of Conformity-MDR

​I agree with you Richard that under the MDD it was common practice that individual Notified Bodies required to include certain standards on the DoC. A reason for that being that the MDD did not identify what was expected on the DoC, several of the Notified Bodies 'invented' their own requirements and even provided example templates. Now with the MDR I sincerely hope that this common practice will fade away and all parties involved stick to the requirements of Annex IV rather than be led by 'what a Notified Body wants'.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands

Original Message:
Sent: 23-Jul-2019 02:32
From: Richard Vincins
Subject: EU Declaration of Conformity-MDR

You are correct there is not any reference specific to having harmonised standards listed on the Declaration of Conformity (DofC) only with the requirement for CS.  However, in experience over the MDD it is common practice to include many of the main harmonised standards like IEC 60601, IEC 62366, and product specific standards/  Most requirements having standards listed actually comes from individual Notified Bodies when they expect content to contain for the DofC.  Definitely inquire or confirm with your Notified Body content of DofC under the EU MDR as there are some changes from the MDD requirements.

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

Original Message:
Sent: 22-Jul-2019 16:48
From: Anonymous Member
Subject: EU Declaration of Conformity-MDR

This message was posted by a user wishing to remain anonymous

Dear RAPS

Should EU Declaration of Conformity contain references to Harmonized standards or only to CS?

I wonder on this because MDR Annex IV asks only for CS, however Harmonized Standards are normally used  as well to declare conformity.

Thank you!

You question is "should", but I'll respond as "must".

 

Thinking only of the medical device portion of the DoC, the requirement includes a reference to any CS used as part of declaring conformity. It does not require a reference to any harmonized standard.

 

However, Article 19 requires that the DoC is a "single EU declaration of conformity". The DoC contains "all the information required for identification of the Union legislation to which the declaration relates". This could include standards harmonized to other directives used to show conformity to those other directives. For example, if the EMC directive were to the device, then the single device DoC might require the EMC harmonized standards used.

 

Because there are many ways to show conformance, my recommendation is to stick to the minimum requirements and not add extra information.

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

Original Message:
Sent: 22-Jul-2019 16:48
From: Anonymous Member
Subject: EU Declaration of Conformity-MDR

This message was posted by a user wishing to remain anonymous

Dear RAPS

Should EU Declaration of Conformity contain references to Harmonized standards or only to CS?

I wonder on this because MDR Annex IV asks only for CS, however Harmonized Standards are normally used  as well to declare conformity.

Thank you!

Harmonized Standards won't be happening any time soon.  I just wrote an article about this.  See it at https://www.meddeviceonline.com/doc/will-we-have-harmonized-standards-by-the-mdr-s-date-of-application-0001
If we are lucky there may be a whole 5 Harmonized Standards to the MDR by the date of application May 26, 2020.  But I wouldn't hold my breath for it to happen.  I am not sure that CEN and CENELEC will agree to the proposal the EU Commission asked them to reply to that I discuss in my article.
I think it will be a long time til Harmonized Standards will be available based on the information in the request and talking to some of my EU associates involved in the standards process.

------------------------------
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
------------------------------

Original Message:
Sent: 22-Jul-2019 16:48
From: Anonymous Member
Subject: EU Declaration of Conformity-MDR

This message was posted by a user wishing to remain anonymous

Dear RAPS

Should EU Declaration of Conformity contain references to Harmonized standards or only to CS?

I wonder on this because MDR Annex IV asks only for CS, however Harmonized Standards are normally used  as well to declare conformity.

Thank you!

​Is there any reason to call out standards on the declaration at all?  Most MDD DofCs I've seen did not call out standards and I see nothing in Article 19 that would require them.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
------------------------------

Original Message:
Sent: 24-Jul-2019 01:47
From: Leonard Eisner
Subject: EU Declaration of Conformity-MDR

Harmonized Standards won't be happening any time soon.  I just wrote an article about this.  See it at https://www.meddeviceonline.com/doc/will-we-have-harmonized-standards-by-the-mdr-s-date-of-application-0001
If we are lucky there may be a whole 5 Harmonized Standards to the MDR by the date of application May 26, 2020.  But I wouldn't hold my breath for it to happen.  I am not sure that CEN and CENELEC will agree to the proposal the EU Commission asked them to reply to that I discuss in my article.
I think it will be a long time til Harmonized Standards will be available based on the information in the request and talking to some of my EU associates involved in the standards process.

------------------------------
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

Original Message:
Sent: 22-Jul-2019 16:48
From: Anonymous Member
Subject: EU Declaration of Conformity-MDR

This message was posted by a user wishing to remain anonymous

Dear RAPS

Should EU Declaration of Conformity contain references to Harmonized standards or only to CS?

I wonder on this because MDR Annex IV asks only for CS, however Harmonized Standards are normally used  as well to declare conformity.

Thank you!

Read COCIRs rebuke to the EU Commission for not stepping up on Harmonized Standards for the MDR & IVDR and my recently published article on the Assessment of the EU Commissions request to the European Standards Organizations (CEN & CENELEC) in regard to Harmonization of Standards.

------------------------------
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
------------------------------

Original Message:
Sent: 25-Jul-2019 11:24
From: Al Van Houdt
Subject: EU Declaration of Conformity-MDR

​Is there any reason to call out standards on the declaration at all?  Most MDD DofCs I've seen did not call out standards and I see nothing in Article 19 that would require them.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States

Original Message:
Sent: 24-Jul-2019 01:47
From: Leonard Eisner
Subject: EU Declaration of Conformity-MDR

Harmonized Standards won't be happening any time soon.  I just wrote an article about this.  See it at https://www.meddeviceonline.com/doc/will-we-have-harmonized-standards-by-the-mdr-s-date-of-application-0001
If we are lucky there may be a whole 5 Harmonized Standards to the MDR by the date of application May 26, 2020.  But I wouldn't hold my breath for it to happen.  I am not sure that CEN and CENELEC will agree to the proposal the EU Commission asked them to reply to that I discuss in my article.
I think it will be a long time til Harmonized Standards will be available based on the information in the request and talking to some of my EU associates involved in the standards process.

------------------------------
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

Original Message:
Sent: 22-Jul-2019 16:48
From: Anonymous Member
Subject: EU Declaration of Conformity-MDR

This message was posted by a user wishing to remain anonymous

Dear RAPS

Should EU Declaration of Conformity contain references to Harmonized standards or only to CS?

I wonder on this because MDR Annex IV asks only for CS, however Harmonized Standards are normally used  as well to declare conformity.

Thank you!

No, none whatsoever, Al. This is not required by either the MDD or MDR.

The template DoC in ISO/IEC 17050-1:2004 does include this wording:
"The object of the declaration described above is in conformity with the requirements of the following documents:
Document No:                Title:                                                                           Edition/Date of issue:"

These "documents" could include standards, but equally may include Directive/Regulations refs, or specification refs.

This standard is referenced by FDA for DoCs relating to standards compliance for premarket submissions, but is not 'harmonised' in Europe, so does not provide a 'presumption of conformity' with the MDD (and likely not the MDR either).

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 25-Jul-2019 11:24
From: Al Van Houdt
Subject: EU Declaration of Conformity-MDR

​Is there any reason to call out standards on the declaration at all?  Most MDD DofCs I've seen did not call out standards and I see nothing in Article 19 that would require them.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States

Original Message:
Sent: 24-Jul-2019 01:47
From: Leonard Eisner
Subject: EU Declaration of Conformity-MDR

Harmonized Standards won't be happening any time soon.  I just wrote an article about this.  See it at https://www.meddeviceonline.com/doc/will-we-have-harmonized-standards-by-the-mdr-s-date-of-application-0001
If we are lucky there may be a whole 5 Harmonized Standards to the MDR by the date of application May 26, 2020.  But I wouldn't hold my breath for it to happen.  I am not sure that CEN and CENELEC will agree to the proposal the EU Commission asked them to reply to that I discuss in my article.
I think it will be a long time til Harmonized Standards will be available based on the information in the request and talking to some of my EU associates involved in the standards process.

------------------------------
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

Original Message:
Sent: 22-Jul-2019 16:48
From: Anonymous Member
Subject: EU Declaration of Conformity-MDR

This message was posted by a user wishing to remain anonymous

Dear RAPS

Should EU Declaration of Conformity contain references to Harmonized standards or only to CS?

I wonder on this because MDR Annex IV asks only for CS, however Harmonized Standards are normally used  as well to declare conformity.

Thank you!