Our Blog

Never miss a thing! The latest regulatory news and updates are always on our feed.

Slider
COVID-19: EC Recommendations and Assessment
The European Commission (EC), the European authority responsible for medical device regulations, issued recommendations on conformity assessment and market surveillance procedures within the context of the threat...
Implant Cards: Further MDCG Guidance
The Medical Device Coordination Group (MDCG), the advisory body of the European Commission composed of representatives of all member states, issued a guidance document dedicated to the Implant Card (IC) to advise the...
UDI and Changes to UDI’s: MDCG Guidance
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI)...
MDCG Guidance on Significant Changes
The Medical Devices Coordination Group (MDCG), an advisory body of the European Commission, issued a guidance document dedicated to the significant changes to medical devices subject to regulation under the Medical...