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MHRA Updates Guidance on Clinical Investigations for Devices

  • Posted by: inetika
  • Category: GLOBAL NEWS

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