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

Draft Commission Implementig Regulation on Annex XVI products published for the feedback procedure until 11 February 2022. Commission Implementing Regulation-AnnexXVI

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 [...]

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 [...]

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

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 [...]

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.

All the information and contact are available on https://app.gignow.com/ey/job_postings/6a654c78d8bb442897d756e9d832b215.

Team-NB representative operates a session on the implementation of the new IVD regulation organised by SIDIV for its members