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
MCDG-Med meetings
All the Notified Bodies designated and the concerned stakeholders have been invited to different meetings taking place remotely on April 5 to 7th.
SNITEM Symposium
The French MD association is organising a symposium on March 14th and requested Team-NB representative to inform the audience on the NBs views regarding new regulations implementation
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
Commission’s sectoral website on medical devices
From now on, a new specific webpage on Harmonised standards is availaible here: https://ec.europa.eu/health/medical-devices-topics-interest/harmonised-standards_en
Common specifications on Annex XVI products
Draft Commission Implementig Regulation on Annex XVI products published for the feedback procedure until 11 February 2022. Commission Implementing Regulation-AnnexXVI
Harmonised standards published
The Commission implementing decision (EU) 2022/15 has been published. It concers harmonised standards for sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer and requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and [...]
Harmonised standards published
The Commission implementing decision (EU) 2022/6 has been published. It concers harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment [...]