The summary of references of harmonised European standards is published in the Official Journal of the European Union in reference to Regulation (EU) 2017/746 on in vitro medical devices.Summary hENs IVDR 7-2023
On December 9th, at the draft agenda under AOB is the Implementation of the Medical Device Regulation (MDR). More info, in the document attached. CM-5507-2022-INIT_en.pdf
CIR-2022-2347-AnnexXVI-20221201.pdf
CIR-2022-2346-AnnexXVI-20221201.pdf
Sheila Walsh from BSI gave an overview of the Notified Bodies’ (NB) initial experience with the medical device expert panel consultation process Link : https://www.ema.europa.eu/en/events/second-industry-standing-group-isg-meeting
Team-NB representative is invited to speak on the NBs perspectives.
The summit gathered representatives from different parties – Commission, NBs, ARs, Manufacturers, consultants, lawyers – from more than 10 European countries, UK and US to exchange on PRRC. photo-PRRC.jpg
The new “Candidate Member” category, approved during the October General Assembly, is to allow organisations (not yet NB neither against the Directives, nor the Regulations) to join the association when they applied to become NB.
A Team-NB representative is going to present the Notified Bodies perspectives on the Regulations implementation. More info: https://www.team-prrc.eu/articles/67843-team-prrc-annual-summit-1st-edition?header=%2Fpage%2F911804-news
Harmonised European standards in support of the Medical Devices Regulation (EU) 2017/745 (MDR) have been adopted on 17 May 2022 to be published in the Official Journal of the European Union (OJEU): https://ec.europa.eu/transparency/documents-register/detail?ref=C(2022)3003
