Lots of prior discussions on European medical device harmonized standards in this Forum. I'll kick this round off:
1. Is it a requirement under EU MDD to list all the applicable harmonized standards on the Declaration of Conformity (DoC)? The outgoing MDD (Directive 93/42/EEC) itself makes no specific provisions for the content of the DoC. Instead, Notified Bodies (NBs) would typically apply EN ISO/IEC 17050-1 as amended. That standard requires the DoC to contain (among other things), "...a complete and clear list of standards or other specified requirements, as well as the selected options, if any...". But see also my further narrative below about harmonized standards.
2. Does Article 120 (transitional provision) of MDR change anything to the above requirement? When a legacy MDD device with a valid MDD certificate the term of which extends up to as long as the EU MDR Article 120 transitional date, then that marketing authorization is based on the conformity assessment that was done against the standards (or other solutions) that were applied at the time the certificate was issued. And those same conformity solutions remain valid for the duration of the certificate's validity unless the NB pushes for updated conformity to a latest state of the art under MDD Annex I.I.2 in the event an applied standard is updated. Different NBs might approach that threshold differently, so it will depend on your particular NB and your contractual arrangement with that NB. The ultimate MDD legislative requirement on that is that the manufacturer must be "taking account" of the generally acknowledged state of the art. It is currently understood that this does NOT mean that conformity with the state of the art is mandatory. Accordingly, if the manufacturer can legitimately (i.e., scientifically) justify in a given case that conformity with an updated standard isn't necessary for assuring compliance with the MDD's Essential Requirements (or the EU MDR's GSPR), then such an approach isn't legislatively prohibited.
3. Under MDD + Article 120 of MDR, are we currently required to comply to the latest version of harmonized standards, or can we list obsolete previous version of the standard on the DoC till we have done the gap assessment? See my preceding response regarding conformity with the latest (i.e., with the state of the art) version of a standard in general. In addition, remember that use of harmonized standards isn't required; it is optional. Both the MDD and the EU MDR make this clear. Much has been spoken of European harmonized standards in this Forum previously, so I'll forego further reiteration of that concept unless further requested. Check out MDCG 2021-5 for additional insights on that.------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------
Original Message:
Sent: 22-Jul-2022 11:26
From: Anonymous Member
Subject: Applicable harmonized standards under EU MDD
This message was posted by a user wishing to remain anonymous
Hi RAPS community,
1. Is it a requirement under EU MDD to list all the applicable harmonized standards on the Declaration of Conformity (DoC)?
2. Does Article 120 (transitional provision) of MDR change anything to the above requirement?
3. Under MDD + Article 120 of MDR, are we currently required to comply to the latest version of harmonized standards, or can we list obsolete previous version of the standard on the DoC till we have done the gap assessment?
Thank you for your insight on this!