Team Notified Body (Team-NB) – the European Association of Notified Bodies active in the medical...
Medical Device Regulations Blog
Last month QMD Services GmbH was designated a Notified Body under Regulation 2017/746 on in-vitro...
The Medical Device Coordination Group (MDCG) – a working group of the European Commission – has...
The European Commission’s Medical Device Coordination Group (MDCG) has published guidance on...
The European Commission has proposed to extend the transitional periods of the Medical Devices...
The European Commission recently adopted two implementing regulations for the MDR. The new...
Essential requirements are a common feature of medical device regulations around the world. At the...
Back in September, the European Commission published its proposal for a new Cyber Resilience Act...
Mutual recognition agreements (MRAs) are arrangements between two or more countries to recognise...