I don't think that there will be an EN ISO 13485:20xx. Instead it appears that EN ISO 13485:2016 will stay in place, augmented by CEN/TR 17223:2018.
I have heard that it uses tables for each part of MDR Article 10 General Obligations of Manufacturers. The adjacent columns then point to other articles and to the referenced annexes. Then they lead to the clauses of ISO 13485:2016 followed by an explanation, similar to Z annexes of EN ISO 13485:2016.
As an aside, it is best, in my opinion, to cite it as CEN/TR 17223:2018. The CEN is very important, because it tells the standards body that issued it. For example, it is not an ISO standard.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 12-Feb-2018 16:40
From: Richard Vincins
Subject: CEN/TR 17223:2018
That is great Dan, thanks for the info.
I was really, really, really (is that too many really?) that they would not do the whole 'Z' annex aspect and just explain how to meet MDR against ISO 13485:2016. We have already done so many mapping between ISO 13485:2016 and the MDR, that it really just needs to be a nice bullet list. Great news to see that they might just actually have a TR to state how to meet the 'intent' of MDR against ISO 13485:2016 ... we will to see what this looks like.
p,.s. (I hope that EN ISO 13485:20xx looks like: follow ISO 13485:2016 & TR 17223:2018 ... fini.)
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Richard Vincins RAC
Vice President Regulatory Affairs
Original Message:
Sent: 11-Feb-2018 09:45
From: Dan O'Leary
Subject: CEN/TR 17223:2018
I checked the CEN website this morning and note that there is progress on CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation.
The abstract says, "This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes."
As I understand it, instead of the traditional Z Annexes for 13485 this document explains how 13485 supports (or doesn't) the QMS requirements for the EU-MDR and EU-IVDR.
The Date of Ratification is 2018-02-12.
The Date of Availability is 2018-04-04.
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Dan O'Leary
Swanzey NH
United States
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