All the Notified Bodies designated and the concerned stakeholders have been invited to different meetings taking place on October 17th to 19th. These meetings will take place remotely.

Following the November 7th session is fully booked, TEAM-NB set up a new date for the MDR technical documentation training for manufacturers on December 14th. MDR Technical Documentation Training for Manufacturers   For registration, follow the link:  ManufacturerTraining

The Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR is available on the Commission website on Medical Devices md_new-reg_annex-xvi_q-n-a_transition-prov

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

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