Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello All 
Where do I find the list of the EU harmonized standards under MDR? 
I can only see the list under MDD.
Thanks

Hello Anon,

Simple answer: There is none.

There are no harmonised standards under the EU MDR or EU IVDR.  There is no timeframe nor any idea when (or if) this will happen.  There are plenty of other discussions on this forum about this topic if you do a search.

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

Original Message:
Sent: 26-Feb-2021 12:53
From: Anonymous Member
Subject: EU Harmonized Standards under MDR

This message was posted by a user wishing to remain anonymous

Hello All
Where do I find the list of the EU harmonized standards under MDR?
I can only see the list under MDD.
Thanks

I'm a bit more optimistic than Richard.

Mario Gabrielli Cossellu from DG Santé and concerned with devices standardization stated on LinkedIn recently that the Commission has submitted a draft of the new request to the opinion of the members of the Committee on Standards, by a 4-week written procedure running until 12 March 2021. Once a positive opinion is delivered, the Commission will proceed to adopt the MDR/IVDR standardisation request as Commission Implementing Decision, through a fast-track procedure by the end of March 2021, to inmediately address it to the European standardisation organisations for their acceptance within 1 month from the notification.

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

Original Message:
Sent: 27-Feb-2021 05:54
From: Richard Vincins
Subject: EU Harmonized Standards under MDR

Hello Anon,

Simple answer: There is none.

There are no harmonised standards under the EU MDR or EU IVDR.  There is no timeframe nor any idea when (or if) this will happen.  There are plenty of other discussions on this forum about this topic if you do a search.

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

Original Message:
Sent: 26-Feb-2021 12:53
From: Anonymous Member
Subject: EU Harmonized Standards under MDR

This message was posted by a user wishing to remain anonymous

Hello All
Where do I find the list of the EU harmonized standards under MDR?
I can only see the list under MDD.
Thanks

This message was posted by a user wishing to remain anonymous

Thank you Richard and everyone. 
I was wondering as if you take a look at Emergo recently published article : https://www.emergobyul.com/blog/2020/06/european-commission-issues-decision-harmonized-standards-mdr-ivdr
They indicated:

• The total number of standards harmonized under the Medical Devices Directive 93/42/EC (MDD) is 264, while the total number of standards for the MDR is 63;

I wondered what is the source for this 63 standards ? 

Thank you again.
Original Message:
Sent: 27-Feb-2021 05:54
From: Richard Vincins
Subject: EU Harmonized Standards under MDR

Hello Anon,

Simple answer: There is none.

There are no harmonised standards under the EU MDR or EU IVDR.  There is no timeframe nor any idea when (or if) this will happen.  There are plenty of other discussions on this forum about this topic if you do a search.

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

Original Message:
Sent: 26-Feb-2021 12:53
From: Anonymous Member
Subject: EU Harmonized Standards under MDR

This message was posted by a user wishing to remain anonymous

Hello All
Where do I find the list of the EU harmonized standards under MDR?
I can only see the list under MDD.
Thanks

The 2 EU Commission Standardization Requests were rejected by CEN & CENELEC and so the M/565 Commission Implementing Decision that references the 63 MDR Harmonised standards have not been issued yet.  This is what was referenced in the Emergo article that they are referring to.  A 3rd Standardization Request from the EU Commission is being drafted and translated into French & German at this time for the MDRs. After translation, the request will be formally submitted to the Member States Committee on Standards (CoS) for approval.  I don't know the timing of this.

------------------------------
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: 02-Mar-2021 11:32
From: Anonymous Member
Subject: EU Harmonized Standards under MDR

This message was posted by a user wishing to remain anonymous

Thank you Richard and everyone.
I was wondering as if you take a look at Emergo recently published article : https://www.emergobyul.com/blog/2020/06/european-commission-issues-decision-harmonized-standards-mdr-ivdr
They indicated:

• The total number of standards harmonized under the Medical Devices Directive 93/42/EC (MDD) is 264, while the total number of standards for the MDR is 63;

I wondered what is the source for this 63 standards ?

Thank you again.
Original Message:
Sent: 27-Feb-2021 05:54
From: Richard Vincins
Subject: EU Harmonized Standards under MDR

Hello Anon,

Simple answer: There is none.

There are no harmonised standards under the EU MDR or EU IVDR.  There is no timeframe nor any idea when (or if) this will happen.  There are plenty of other discussions on this forum about this topic if you do a search.

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

Original Message:
Sent: 26-Feb-2021 12:53
From: Anonymous Member
Subject: EU Harmonized Standards under MDR

This message was posted by a user wishing to remain anonymous

Hello All
Where do I find the list of the EU harmonized standards under MDR?
I can only see the list under MDD.
Thanks

The reason you cannot find a list of Harmonized standards for MDR /IVDR is that there are none. The EC and the European standards bodies CEN and CENELEC have not reached an agreement on the process yet, but have been making attempts to do so. I'm sure when the agreement is reached the news will be widely distributed.

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

Original Message:
Sent: 26-Feb-2021 12:53
From: Anonymous Member
Subject: EU Harmonized Standards under MDR

This message was posted by a user wishing to remain anonymous

Hello All
Where do I find the list of the EU harmonized standards under MDR?
I can only see the list under MDD.
Thanks

Original Message:
Sent: 2/26/2021 12:53:00 PM
From: Anonymous Member
Subject: EU Harmonized Standards under MDR

This message was posted by a user wishing to remain anonymous

Hello All 
Where do I find the list of the EU harmonized standards under MDR? 
I can only see the list under MDD.
Thanks

I'm not as optimistic as Mario is that the 3rd Standardization Request from the EU Commission will have much success based on what I have heard from EU big manufacturers & SMEs involved in COCIR.  The Commission has not listened to the feedback provided and so we will have to see what happens.

So, my question is what are different Notified Bodies expecting for MDD and MDR before and after the MDR date of application for Harmonized Standards or lack thereof (in the case of MDR currently as there are none as State of the Art is not clearly defined what is expected and there is no clear Guidance as Mario even points out in his LinkedIn post that MDCG is still working on it through a committee so we are left with what each NB has come up with.). So, what is each NB doing for the expectation of State of Art Standards for MDR & also MDD as I expect that will be going on til at least the end of this year before MDCG comes out with a guidance on this issue?

Thx

------------------------------
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: 26-Feb-2021 12:53
From: Anonymous Member
Subject: EU Harmonized Standards under MDR

This message was posted by a user wishing to remain anonymous

Hello All
Where do I find the list of the EU harmonized standards under MDR?
I can only see the list under MDD.
Thanks

Dear Anon,

As per replies from other forum members and eager as it may be for MDR, we have considered quarterly checking of standards where they publish them in OJEU as best practice:

i.e. https://ec.europa.eu/growth/content/new-2020-lists-harmonised-standards-medical-devices-are-now-available_en

------------------------------
Eric Ngo
Snr Regulatory Affairs Manager
Port Melbourne VIC
Australia
------------------------------

Original Message:
Sent: 26-Feb-2021 12:53
From: Anonymous Member
Subject: EU Harmonized Standards under MDR

This message was posted by a user wishing to remain anonymous

Hello All
Where do I find the list of the EU harmonized standards under MDR?
I can only see the list under MDD.
Thanks