The REGULATION (EU) 2024/1860 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices is published [...]
TEAM-NB set up a new date for the MDR technical documentation training for manufacturers on November 06th , 2024. MDR Technical Documentation Training for Manufacturers For registration, follow the link: ManufacturerTraining
MDCG 2021-5 Guidance on standardisation for medical devices – revised version published on the Commission’s webpage. md_mdcg_2021_5_en.pdf
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-v02-20240702-with-instructions.pdf
AFNOR is becoming a full member following is newly designation against MDR in France.
The press release and the graphs with all data from the 35 members at end 2023 are available now. They are both available in the Team-NB Documents
Team-NB welcomes a new member from Italy : ICIM Spa (Notified Body N° 0425).
The European Society of Minimally Invasive Neurological Therapy issues a call for experts in neurointerventions to work with notified bodies in the certification process of medical devices within the European Union (EU). See more info in the press release. Call-for-Experts-Press-Release_240423.docx
TEAM-NB set up a new date for the IVDR technical documentation training for manufacturers on July 3rd , 2024. IVDR Technical Documentation Training for Manufacturers For registration, follow the link: ManufacturerTraining
Relaxing time after election and before 2 years of intensive work at the service of the members to ease implementation of the legislative framework for the well-being of all patients.
