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MHRA Guidance for Medical Device Manufacturers on Vigilance

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  1. the manufacturer
  2. the UK Responsible Person
  3. the Authorised Representative based in Northern Ireland
  1. Manufacturer Incident Report (MIR)
  2. Field Safety Corrective Actions (FSCAs)
  3. Trend Reports
  4. Periodic Summary Reports (PSRs)
  5. A new web form to enable submission of Serious Adverse Events (SAEs)
  1. Manufacturers,
  2. Authorised Representatives (NI),
  3. UKRP
  4. Other importers, distributors, or submitters
  1. An event has occurred. This includes situations where testing performed on the device, examination of the information supplied with the device, or any scientific information indicates some factor that could lead or has led, to an event
  2. The manufacturer’s device is suspected to be a contributory cause of the incident
  3. The event resulted in, or might have resulted, in death or a serious deterioration in state of health of a patient, user, or other person
  1. An incident is associated with a device happened, and
  2. If it occurred again, it might lead to death or serious deterioration in health