Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello RAPS!

I recently switched to the RA space, and have been given the responsibility to update the Quality Manual w.r.t. the EU MDR. I am searching for co-relations between the requirements of the MDR and ISO 13485:2016 throughout the respective documents, and was wondering if anyone here could point me to a resource that could potentially aid in my search. 

Thanks in advance!

Hi,

this is actually not that easy as the devil is in the details of the MDR. However, quality management system requirements are mainly stated in Article 10 of the MDR, which resembles a lot of the requirements of ISO 13485. Importantly, the MDR obligates manufacturers to some additional aspects that are currently not covered by the ISO (e.g. UDI). My recommentdation would be to update the QM in a way that it references both documents.

Hope that helps - All the Best

Markus

------------------------------
Markus Lantermann
Head of Q&R Region International
Roche Diagnostics - ENTERPRISE
Mannheim
Germany
------------------------------

Original Message:
Sent: 27-Apr-2021 12:25
From: Anonymous Member
Subject: EU MDR & ISO 13485 co-relation

This message was posted by a user wishing to remain anonymous

Hello RAPS!

I recently switched to the RA space, and have been given the responsibility to update the Quality Manual w.r.t. the EU MDR. I am searching for co-relations between the requirements of the MDR and ISO 13485:2016 throughout the respective documents, and was wondering if anyone here could point me to a resource that could potentially aid in my search.

Thanks in advance!

On short notice, check out:

CEN/TR 17223:2018 - provides guidance on the relationship between EN ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes and the requirements in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic Medical Devices. 

At the moment, draft Annexes Z are being prepared for EN ISO 13485. they are not to far out from publication.

------------------------------
Robert van Boxtel
Principal Consultant Medical Device Project B.V.
MDProject
Alphen a/d Rijn
Netherlands
------------------------------

Original Message:
Sent: 27-Apr-2021 12:25
From: Anonymous Member
Subject: EU MDR & ISO 13485 co-relation

This message was posted by a user wishing to remain anonymous

Hello RAPS!

I recently switched to the RA space, and have been given the responsibility to update the Quality Manual w.r.t. the EU MDR. I am searching for co-relations between the requirements of the MDR and ISO 13485:2016 throughout the respective documents, and was wondering if anyone here could point me to a resource that could potentially aid in my search.

Thanks in advance!

Hello Anon,

This is in fact an exercise we go through in our EU MDR courses mapping content of the regulation (mainly focusing on Article 10 as a whole) against ISO 13485 and a "standard" quality management system.  This is also something we go through during an EU MDR assessment of a company's quality management system.  It can be significant amount of work depending on the company, type of product, classification, and structure of the quality system.  As this is work usually performed by consultancy firms, I am not sure you will find an exact resource out there beyond CEN/TR 17223 as Robert pointed out.  And CEN/TR 17223 does only address Article 10, but there are many other components of the EU MDR which need to be considered for inclusion in the quality system.  A final comment, while updating your Quality Manual to EU MDR is good, there are other processes and procedures which are impacted by EU MDR requirements which should encompass an approach by defining a Transition Quality Plan to address all requirements needed based on your organisation.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
Emergo Group Inc
------------------------------

Original Message:
Sent: 28-Apr-2021 02:28
From: Robert van Boxtel
Subject: EU MDR & ISO 13485 co-relation

On short notice, check out:

CEN/TR 17223:2018 - provides guidance on the relationship between EN ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes and the requirements in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic Medical Devices. 

At the moment, draft Annexes Z are being prepared for EN ISO 13485. they are not to far out from publication.

------------------------------
Robert van Boxtel
Principal Consultant Medical Device Project B.V.
MDProject
Alphen a/d Rijn
Netherlands

Original Message:
Sent: 27-Apr-2021 12:25
From: Anonymous Member
Subject: EU MDR & ISO 13485 co-relation

This message was posted by a user wishing to remain anonymous

Hello RAPS!

I recently switched to the RA space, and have been given the responsibility to update the Quality Manual w.r.t. the EU MDR. I am searching for co-relations between the requirements of the MDR and ISO 13485:2016 throughout the respective documents, and was wondering if anyone here could point me to a resource that could potentially aid in my search.

Thanks in advance!

You are down to the wire for sure.  May 26th is quickly approaching!  I truly wish you the best!  We have been working on this project for 6+ months at our company, so no easy feat. 

I found the following references very helpful:

https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/md_manufacturers_factsheet_annex_en.pdf

This RAPS book has an entire chapter dedicated to QMS and has a correlation chart between ISO 13485 and the MDR.  This proved very helpful for me. 
https://my.raps.org/online-store/merchandise-details/?id=1a469922-2f6f-4f61-8c3b-bde7c241e9c7

BSI has many whitepapers and webinars:
https://www.bsigroup.com/en-US/medical-devices/Our-services/MDR-Revision/

Greenlight Guru and RQM+ have hosted countless webinars and written many white papers.  Both some of the best free resources out there!
https://www.greenlight.guru/medical-device-resources
https://www.rqmplus.com/resources

------------------------------
Alyssa Roelli
Regulatory Projects Manager
Diversatek Healthcare
Milwaukee WI
United States
------------------------------

Original Message:
Sent: 27-Apr-2021 12:25
From: Anonymous Member
Subject: EU MDR & ISO 13485 co-relation

This message was posted by a user wishing to remain anonymous

Hello RAPS!

I recently switched to the RA space, and have been given the responsibility to update the Quality Manual w.r.t. the EU MDR. I am searching for co-relations between the requirements of the MDR and ISO 13485:2016 throughout the respective documents, and was wondering if anyone here could point me to a resource that could potentially aid in my search.

Thanks in advance!

This message was posted by a user wishing to remain anonymous

Thank you all for your replies!

I have ordered a copy of the CEN/TR 17223:2018, and am in the process of gleaning as much information from the resources everyone has been kind enough to provide. I am grateful for this community, and look forward to more knowledge exchange.
Original Message:
Sent: 27-Apr-2021 12:25
From: Anonymous Member
Subject: EU MDR & ISO 13485 co-relation

This message was posted by a user wishing to remain anonymous

Hello RAPS!

I recently switched to the RA space, and have been given the responsibility to update the Quality Manual w.r.t. the EU MDR. I am searching for co-relations between the requirements of the MDR and ISO 13485:2016 throughout the respective documents, and was wondering if anyone here could point me to a resource that could potentially aid in my search.

Thanks in advance!