MHRA Updates Guidance on Clinical Investigations for Devices
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance for device sponsors on notifying the agency about clinical investigations to support a CE Mark.
The new additions to the guidance are intended to help device manufacturers understand when clinical investigations are required for their devices. For example, the guidance directs sponsors to ask what “essential requirements” a device has for demonstrating regulatory compliance, and what data is necessary for showing it.
Devicemakers should consider what testing is needed to produce compliance data and if clinical data is actually needed for showing adherence to regulations, the agency said.