I have wondered if this might be related to the EC's proposals to keep the "dying" MDD on life support for another year, by which time, who knows, it might be the MDR that is dying. Perhaps as they proposed keeping the MDD for another year, they wanted to avoid the criticism that "the standards haven't even been harmonized"? Although I agree with Richard that everyone should be using the most current version of the standards, harmonized or not, I think the proposal drags things into the political realm, and I'm doubtful politicians understand any of this, while "those standards haven't even been harmonized" just doesn't sound good.
I have also wondered if updating the list served as an opportunity to say that these standards "
may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/745".------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 31-Mar-2020 06:17
From: Spyros Drivelos
Subject: MDD Harmonized Standards
From what i know, there was a lot of pressure to the EU to harmonize some standards, because they stopped harmonizing from 2017.
So, they just harmonized some standards that are useful for the devices which are used throughout the Covid crisis.
In my opinion, it is a stupid move and very sloppy. I do not see the point of harmonizing some standards for a "dying" directive. Are they going to harmonize this year also standards for MDR? I do not think so...
------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
Original Message:
Sent: 29-Mar-2020 12:06
From: Dan O'Leary
Subject: MDD Harmonized Standards
There is a new Commission Implementing Decision on harmonized standards for the MDD. You can download it at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2020.090.01.0001.01.ENG&toc=OJ:L:2020:090I:TOC
One important point is Article 3, "The harmonized standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annexes I and II to this Decision may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/745".
For 13485 the harmonized standard becomes EN ISO 13485:2016 with EN ISO 13485:2016/AC:2018.
For 14971, the harmonized standard remains EN ISO 14971:2012.
There is a similar list for the IVDD at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2020.090.01.0033.01.ENG&toc=OJ:L:2020:090I:TOC
------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------