European Commission Publishes MDR and IVDR Factsheet for Non-EU/EEA Countries

Elizabeth Anne Wright , Jessica Lauren Koffel and Alix Vermulst

On 12 July 2023, the European Commission published a factsheet for authorities outside the European Union (EU) and the European Economic Area (EEA) on the implications of the extended deadlines in Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

UK Government Provides Limited Extensions to Recognition of CE Marks for Medical Devices in Great Britain 

Elizabeth Anne Wright , Jessica Lauren Koffel and Alix Vermulst

On 1 August 2023, the UK government announced plans to extend recognition of CE marking ‘indefinitely’ for certain products placed on the Great Britain market (England, Wales and Scotland).

GCP Q&A Clarifies Sponsor Role in Trial-Related Tasks, Provides Other Updates

The European Medicines Agency (EMA) has updated its Q&A for good clinical practice (GCP). The update acknowledges that the sponsor may support the investigator by identifying or contracting service providers in the conduct of the clinical trial. This update reflects the leading role of sponsors in interaction with contracting service […]