Hi Karen, in March 2018 a Technical Report (CEN/TR 17223:2018) was published which acts as guidance on the relationship between EN ISO 13485: 2016 and EU MDR & IVDR. I consider this as a good starting point to find the gaps, but also experienced it to be incomplete. It covers mainly the gaps regarding art. 10 General obligations of manufacturers. All kinds of detailed requirements regarding PRRC (art.15), PMS (art.83 onwards), Vigilance (art.87 onwards), etc., etc. are not identified as gap in this Technical Report. It requires working through the requirements of the MDR and implementing the applicable requirements in a suitable place in the QMS. Advantage of this approach is that you also gain extensive knowledge on the contents of the MDR itself.
Whenever you want to start placing your products on the EU market, your QMS must be MDR ready beforehand and in many cases certified by a Notified Body depending on the conformity assessment route chosen.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
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Original Message:
Sent: 13-Feb-2020 12:33
From: Karen Zhou
Subject: Gap Between ISO 13485 and EU MDR
Hi everyone,
For a company that is moving directly from ISO 13485:2016 to EU MDR, does anyone know if there is a gap analysis out there between an ISO 13485 QMS and and an EU MDR QMS? I am in a situation where we are building a QMS from scratch based on ISO 13485:2016 and MDSAP, and there are plans in the near future to move to the EU and it's not clear when in the future. When is the best time to switch to the EU MDR QMS? How different is the ISO 13485:2016 QMS from a QMS based on EU MDR? I appreciate any insight.
Thanks.
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Karen Zhou
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