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Exemptions from reporting

Regulatory basis

Exemptions are addressed in MHRA's adverse incident reporting guidance. They are narrowly construed — when in doubt, report.

Valid exemptions from individual reporting​

1. Expected events disclosed in IFU at documented frequency​

A known adverse event that is disclosed in the IFU as a recognised risk, occurring at a rate no higher than documented in the clinical data and IFU, may not require individual reporting. It must still be captured in PMS data for trend monitoring.

2. Malfunction with no risk of harm​

A device malfunction that did not and could not have led to death or serious deterioration is not a reportable serious incident.

3. Use error where device performed correctly and IFU was adequate​

User error that was clearly contrary to unambiguous IFU, not a foreseeable misuse, and not attributable to inadequate labelling — may not be a reportable device event.

What is never exempt​

  • Death linked to device malfunction → always report
  • Harm outside the disclosed risk profile → always report
  • Any FSCA or recall → always notify MHRA
  • Any event where reportability is uncertain → report and let MHRA assess

Documenting non-reporting decisions​

All decisions not to report must be documented in the vigilance log:

  • Event description
  • Exemption criteria applied and why they are met
  • Person who assessed reportability and their qualifications
  • Date of assessment
  • Confirmation that the event is captured in PMS for trend monitoring

Official references​

ReferenceDescription
UK MDR 2002, Regulations 16–22Basis for exemption analysis
MHRA: Adverse incident reporting guidanceExemption criteria