Team-NB – General Assembly meeting
The association meeting is scheduled on April 10th.
The association meeting is scheduled on April 10th.
RISE is becoming a full member following is newly designation against MDR in Sweden.
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