On 27 November 2025, the Official Journal of the EU released Commission Decision (EU) 2025/2371. With this announcement, ‘Actors’, ‘UDI and devices’, ‘Notified bodies and…
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…
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…