Following legal requirements, the statutes were updated in presence of 95% of the members. The association is intending to be active in promoting harmonisation among its members and also continuing to help manufacturers to understand and meet the legislations to enhance patients safety.
TÜV SÜD Danmark is becoming a full member following is newly designation against MDR in Denmark.
All the Notified Bodies designated and the concerned stakeholders have been invited to different meetings taking place on April 9th to 11th. These meetings will take place at the NH Collection Grand Sablon.
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).
