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

A reception took place in Brussels representatives of the Commission, CAMD, Industry, and Notified Bodies. Read more in the attached press release concerning the exchanges of views during the panel. TEAM-NB-22Anniversary-PressRelease-20230420.docx

Team-NB welcomes a new Canditate member from Denmark, as the 4th member of the new category of NB in the designation process. From now on, the association has 40 members from 20 different countries  

Team-NB welcomes a new member from Finland Eurofins (Notified Body N° 0537) . From now on, the association has 39 members.