From 19 August 2024, the European Commission opened a public consultation on common specifications for…
Updated guidance on standardisation for medical devices
In July 2024, the Medical Device Coordination Group (MDCG) updated its guidance MDCG 2021-5 on…
Annex XVI devices: MDR requirements and deadlines
To be placed on the EU market, certain products without an intended medical purpose have…
Annex XVI devices: Common specifications and reclassification
The official journal of the European Union now includes two Commission Implementing Regulations on Annex…