All the Notified Bodies designated and the concerned stakeholders have been invited to different meetings taking place on October 4th to 6th. (These meetings will take place remotely)

Health Care Without Harm (HCWH) Europe invited Team-NB representative at a webinar they organise on 27 September to discuss MDR implementation. More information : https://noharm-europe.org/

The association meeting is scheduled on October 5th

The MDCG endorsed document advised actions such as hybrid audits, organize structured dialogues with manufacturers to improve the efficiency of the conformity assessment process, and so on see more information: 14 mdcg 2022-14 position paper_actions transition mdr-ivdr    

Published for 4 weeks consultation (document accessible to https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en

The Commission published Frequently asked questions on medecines and medical devices concerning sanctions adopted following Russia’s military aggression against Ukraine and Belarus'faqs-sanctions-russia-medical_en

Team-NB-PositionPaper-ConfAssessment-Multiplexassays-V1 Thanks to the work of the IVD working group, Team-NB came with a Position Paper on “Conformity assessment of multiplex assays” The paper has been approved by a large majority of members designated in the IVD sector.  

The “Notice to manufacturers to ensure timely compliance with MDR requirements has been published MDCG-2022-11-PositionPaper

The draft published today in the “Notification system” of European standardisation is open for feedback until 30 June 2022 https://ec.europa.eu/growth/single-market/european-standards/notification-system_en#future

In the absence of an update of the MRA to include Regulation (EU) 2017/746, the part of the MRA chapter covering in vitro diagnostic medical devices ceases to apply as of 26 May 2022. Standardized confirmation letter rev 1 IVDDApr22(1)