A key aspect of MDCG 2021-5 that I've found refreshing is the reiteration of the longstanding principle that harmonized standards, and even standards that are considered to represent the "state of the art", are fundamentally voluntary. This tends to provide another official negotiating tool available to manufacturers when a notified body demands compliance with a certain standard. That said, in practice, it has typically been, and I think will continue to be, very useful for manufacturers to apply a preexisting standardized paradigm rather than reinventing the wheel and having to argue its conformity invention with the notified body. Indeed, oftentimes, making and supporting the argument costs more than applying a standardized preexisting paradigm.
Regarding the HAS consultants response to EN ISO 14971:2019, I believe a number of their more substantive objections are based on subjective unsustainable opinions, bias, and/or demonization of manufacturers (maybe intentional, maybe not) and, in at least one instance, apparent misinterpretation and consequent misuse of supporting background.
Regarding conflicts between standards and legislation, remember that the Annex Z aspect of the European standard harmonization process is fundamentally intended to act as a bridge where a standard's normative contents conflict with an applicable regulatory requirement. Case in point, the content deviations published in the Z Annexes of EN ISO 14971:2012 (more about that in a moment). Accordingly, it is neither expected, nor realistic to expect, that the normative content of a standard like ISO 14971:2007 (the normative heart of EN ISO 14971:2012) or like ISO 14971:2019 (the normative heart of EN ISO 14971:2019) be in full alignment with applicable legislation. Thus, the intended beauty of the Annexes Z.
That said, the EN ISO 14971:2012 Annexes Z created quite a kerfuffle. Yet, the kerfuffle was effectively and rightfully clarified (in my opinion) by the Consensus Paper from the Notified Bodies Recommendation Group (NBRG). For example, NBRG clarified that IFU can in fact be used as a risk control. I have been practicing and applying the NBRG's reinterpretations for years now without problem.
In any case, these unavoidable dynamics and challenges are rendered quite manageable (in my opinion) by the fundamentally voluntary nature of harmonized standards along with the flexibility in the "state of the art" concept intended by legislation like the EU MDR.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 14-May-2021 11:45
From: Anonymous Member
Subject: MDCG 2021-5 and state of the art and standards
This message was posted by a user wishing to remain anonymous
What do folks think of the new MDCG guidance and its impact on standards and state of the art?
I ask as our Notified Body questioned our use of harmonised standards rather than most recently published standards. While the new guidance doesn't explicitly state that harmonised standards are by definition state of the art, it feels like that is the implication.
What do others think about this new guidance?