MHRA Updates Guidance on Clinical Investigations for Devices

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance titled ‘Notify MHRA about a clinical investigation for a medical device‘ for study sponsors on notifying the agency about clinical investigations to support a CE Mark.

The guidance covers the following topics:

• How to notify MHRA of your clinical investigation
• In Vitro Diagnostic Medical Devices (IVDs)
• Special circumstances for healthcare establishments
• Heath Research Authority (HRA) approval
• More information