MDCG 2022-11 – Position Paper
The “Notice to manufacturers to ensure timely compliance with MDR requirements has been published MDCG-2022-11-PositionPaper
Draft “Commission Implementing Decision on a standardisation request”
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
IVD in Swiss in absence of MRA
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)
List of references
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
Team-NB MD Sector Survey PressRelease
The annual Team-NB sector press release is available via the blue Team-NB Documents button below the picture
List of references
Harmonised European standards in support of the In VitroDiagnostic Medical Devices (IVDR) have been adopted on 11 May 2022 to be published on 12 May in the Official Journal of the European Union CELEX 32022D0729 EN TXT
The European Commission published a “Recommendation to the Notified Bodies established in a Member State of the EU in the context of the situation in Ukraine”
More info in the attached document (COM-NB)_ZB_gc_Ukraine recommandations_1909181
Team-NB General Assembly
The association meeting is scheduled on April 6th.
Virtual 6th EAAR Annual Conference on New Medical Device Regulations
Team-NB has been invited to address the NBs point of view on the new regulations implementation.
IVDR amending Regulation
This amending regulation as regards transitional provisions for certain IVDs has been published. Here is the document.COM-2022-112