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
The press release is presenting the outcomes of the course and the progress of the manufacturers towards their transition to MDR thanks to responses of the attendants. Info on the 1st MDR training session : PressRelease-Training-for-MD-manufacturers-20231123
