Team-NB welcomes a new member from Türkiye : UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. (Notified Body N° 2292).

Thanks to the work of the task force, Team-NB members approved a Position Paper “Classification of SARS Cov2” addressing the reclassification. Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf

The guidance endorsed by MDCG and platform have been made publicly available Link: European Medical Device Nomenclature (EMDN) (europa.eu)

The fourth session is fully booked, TEAM-NB set up a new date for the MDR technical documentation training for manufacturers on April 29th , 2024.   MDR Technical Documentation Training for Manufacturers   For registration, follow the link:  ManufacturerTraining

Thanks to the work of the task force, Team-NB members approved a Position Paper on “MD Lifetime” that is addressing Lifetime with the objective to consider different device types of a medical device lifetime in terms of safe and effective use. Team-NB-PositionPaper-Lifetime-Medical-Device-20231127.pdf

MDCG endorsed at their meeting of December 12th, 2023 the 2 below guidances: Qualification and classification of Annex XVI products (MDCG 2023-5) Demonstration of equivalence for Annex XVI products (MDCG 2023-6)

The press release is presenting the outcomes of the 2nd training course and the progress of the manufacturers of the 2 first sessions towards their transition to IVDR thanks to responses of the attendants. PressRelease-Training-for-IVD-manufacturers-20230907.pdf

5 laboratories designated covering the 4 categories of class D devices.   More info: MDCG-2023-2713-COMMISSION-IMPLEMENTING-REGULATIONEU.pdf

The third session is fully booked, TEAM-NB set up a new date for the MDR technical documentation training for manufacturers on March 27th , 2024.   MDR Technical Documentation Training for Manufacturers   For registration, follow the link:  ManufacturerTraining

Both 1st sessions are fully booked, TEAM-NB set up a new date for the IVDR technical documentation training for manufacturers on February 1st, 2024.   IVDR Technical Documentation Training for Manufacturers   For registration, follow the link:  ManufacturerTraining