MHRA Updates Guidance on Clinical Investigations for Medical Devices
The MHRA has updated its guidance on clinical investigations for medical devices, covering notification requirements, fees, applications, assessment, amendments, reporting and Northern Ireland requirements.
Swissmedic Updates Information Sheet on IVD Performance Studies
Swissmedic has updated its information sheet on performance studies of IVDs, covering study categories, approval processes, ISO 20916, reporting duties, safety measures and sponsor obligations.
MHRA Updates Guidance on Clinical Investigations and Introduces 2026–2027 Fee Waiver Pilot
MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.