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

This Position Paper is going to be revised by a task force to be formed. As a 1st step, it has been put in the list as “under revision“. See list in https://www.team-nb.org/team-nb-documents/

See attached a group photograph of the participants to the Leuven event on April 17h CORE-MD_ConsortiumPhotograph.jpg

Team-NB welcomes a new member from Poland CeCert (Notified Body N° 2934).

During Team-NB General Assembly Meeting on April 19th, all the members presents voted to approve the version 2 of this Best Practice Guidance. Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V2-20230419