The Medical Devices Coordination Group (MDCG) has published guidance discussing the health...
Articles by Alec Denniff, Medical Device Paralegal
The UK Life Sciences Council has issued a statement concerning their agreement to publish proposals...
Team Notified Body (Team-NB) – the European Association of Notified Bodies active in the medical...
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 has proposed to extend the transitional periods of the Medical Devices...
The European Commission recently adopted two implementing regulations for the MDR. The new...
The Medical Devices Coordination Group (MDCG) has issued new guidance on authorised representatives...
The European Commission has released an updated EUDAMED timeline, targeting the second quarter of...
Australia’s Therapeutic Goods Administration, the national regulator for medical devices, has...