Commission Implementing Decision (EU) 2024/817 of 6 March 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products and packaging for terminally sterilised medical devices OJ L, 2024/817, 08.03.2024

Commission Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products. OJ L, 2024/815, 08.03.2024  

CORE-MD organises a webinar on March 25th from 17.00 CET on the Notified Body Role & The Conformity Assessment Process  

The fifth session is fully booked, TEAM-NB set up a new date for the MDR technical documentation training for manufacturers on June 12th , 2024.   MDR Technical Documentation Training for Manufacturers   For registration, follow the link:  ManufacturerTraining

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)