Team-NB General Assembly
The association meeting is scheduled on October 5th
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)
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
The annual Team-NB sector press release is available via the blue Team-NB Documents button below the picture