The 2nd session of this training dedicated to manufacturers is fully booked since June. It will take place 1st week of September. A 3rd session date will be communicated shortly.

Team-NB members adopted a template agreement specifying the terms of the transfer of the surveillance according to Regulation 2017/7451 for legacy devices. Team-NB-PositionPaper-TransferAgreement-V1-20230811

Team-NB members specify in this paper their views on the amended timelines with regards to benefits for the European patients and as the continuity in the availability of essential medical devices in the European market.Team-NB-PositionPaper-MDRTransitionTimelines-NotifiedBodyCapacity-V1

The attached press release is presenting the outputs of the 1st training session.PressRelease-Training-for-IVD-manufcaturers-20230706

The summary of references of harmonised European standards is published in the Official Journal of the European Union in reference to Regulation (EU) 2017/745 on medical devices.Summary hENs MDR 7-2023

Team-NB welcomes a new Canditate member from Poland, as the 5th member of the new category of NB in the designation process. From now on, the association has 42 members from 20 different countries

The act is applicable from today and has been published on the Official Journal of the European Union.

The 2nd session scheduled for September 7th is also complete. The requests for participation received from now on will be registered pending the setting of a new date for a 3rd session.

The Commission published the « Template notified body confirmation letter » on the Public Health - Medical Devices web page. For more info, see following link: https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/overview_en

After some updates taking into consideration some remarks and in an aim of harmonisation, the version 2 of this position paper is available. Team-NB-PositionPaper-HybridAudits-V2-20230516.docx