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 [...]
Team-NB representative invited to give NBs point of view at the “Forum Risk Management”
Medical Devices made of substances research and innovation opportunities for a sustainable healthProgramma-DispositiviMedici-ENG
NCAs list to perform consultations
Information from HMA on which national competent authorities (NCAs) have the capabilities to perform drug-device combination product consultations. See the link on HMA website: https://www.hma.eu/57.html
EUDAMED gradual roll-out
Here is the summary of decisions taken : • the UDI/Device module will be released in Production in September 2021. Voluntary use is possible and workable. • the NBs and Certificates module will be released in Production in September 2021 with the exception of the CECP and the Mechanism for scrutiny, which will remain in [...]
Team-NB Academy organises its 1st “Remote audits training”
The aims are to help the auditors to assess in a remote way againt MDR and to harmonise practices. It appears that the practices are already reasonably harmonised; only minor differences. A second training is already planned end of August.