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…
EUDAMED: timeline as of August 2025
This summer, the European Commission was expected to announce the functionality of five EUDAMED modules. With this announcement, Actor, UDI/Devices, notified body/certificates as well as…
New expert group under MDR
A new expert subgroup of the MDCG was established to cover Annex XVI products; therefore issues with products without an intended medical purpose but falling…
Clinical Evaluation Report: New MDR implementation tool
The results of clinical evaluation and clinical evidence on which it is based shall be documented in a clinical evaluation report (CER), which shall support…
MDCG Guidance on Basic UDI-DI
Updated guidance was just published by the MDCG to better clarify the notion of Basic UDI-DI, its usage and when a UDI-DI requires changes. The…
Official MDR & IVDR Corrigendum published!
On May 3rd 2019, the Corrigendum of both Regulations was published in the Official Journal of the European Union. MDR Corrigendum IVDR Corrigendum Apart from…