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

The revision 1 of the MDCG 2020-3 regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD May 2023 and taking into consideration Regulation 2023/607 has been published. More info: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en  

The draft implementing regulation is published for consultation until 5 June 2023 on the Commission website. See attachment CIR-Provision-AnnexXVI-2023.pdf

Team-NB members mobilized and within 1 week they approved the confirmation letter to be issued under Regulation 2023/607. Team-NB-PositionPaper-NB-ConfirmationLetterEU2023-607-20230503.docx