RISE
Team-NB welcomes a new Canditate member from Sweden, as the 1st member of the new category of NB in the designation process. From now on, the association has 33 members from 19 different countries
MDCG 2022- 2021, Guidance on PSUR
The awaited Guidance on Periodic Safety Upadate Report according MDR is available on the EU website MDCG-2022-21-PSUR.pdf
Designation of notified bodies under the upcoming Artificial Intelligence Act
This position paper was prepared by the “AI & mobile app.” task force which include 16 representatives of the members. It was endorsed by electronic mechanism by a vast majority of members. The paper is underlying the importance of an update of the processes & personnel competence to align with the AI requirements, but not [...]
EPSCO meeting
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
Implementing Regulation 2022/2347 related to reclassification for certain Annex XVI active products has been published on December 1st
CIR-2022-2347-AnnexXVI-20221201.pdf
Implementing Regulation 2022/2346 related to Common Specifications for Annex XVI products has been published on December 1st
CIR-2022-2346-AnnexXVI-20221201.pdf
New-Member : SGS Fimko Ltd -NB0598
Team-NB welcomes a new member from Finland. From now on, the association has 32 members from 19 different countries
EMA meeting of Sept 26th: Industry Standing Group (ISG) meeting
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
ESC Meeting – 22 Nov 2022 – Paris – “Device innovation in CV medicine”
Team-NB representative is invited to speak on the NBs perspectives.
Team-PRRC 1st summit
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