From 19 August 2024, the European Commission opened a public consultation on common specifications for certain vitro diagnostic medical devices. For four weeks, until 16…
Updated guidance on standardisation for medical devices
In July 2024, the Medical Device Coordination Group (MDCG) updated its guidance MDCG 2021-5 on standardisation for medical devices, first published in 2021. In the…
Annex XVI devices: MDR requirements and deadlines
To be placed on the EU market, certain products without an intended medical purpose have to comply with the Medical Devices Regulation (MDR). Annex XVI…
Annex XVI devices: Common specifications and reclassification
The official journal of the European Union now includes two Commission Implementing Regulations on Annex XVI of the Medical Devices Regulation 2017/745 (MDR). The first…