In November 2025, MedTech, AESGP, COCIR and EUROMCONTACT released a joint position paper on digital label for Authorised Representative and Importer details. The European associations…
Updated EUDAMED features: EAR to be notified of new Basic UDI
EUDAMED has recently introduced new features to their system. The database is regularly subject to improvements and updates. In the latest release, EUDAMED has several…
Guidance on EAR: obligations and responsibilities under the Regulations
In October 2022, the Medical Device Coordination Group (MDCG) published a new Guidance on obligations and responsibilities of the Authorised Representative. According to the Regulations…