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What must be reported to MHRA

Regulatory basis

Vigilance reporting requirements are in Regulations 16–22 of the UK MDR 2002 (Part I), updated by SI 2019/791. MHRA's adverse incident reporting guidance provides detailed implementation guidance.

Three categories of reportable event​

1. Serious incidents​

A serious incident is any malfunction or deterioration in the characteristics or performance of a device — including use-error attributable to inadequate IFU — that has led to, or could have led to:

  • The death of a patient, user, or other person, or
  • A serious deterioration in the state of health of a patient, user, or other person

"Serious deterioration" includes: life-threatening illness or injury; permanent impairment of body structure or function; hospitalisation or prolongation of existing hospitalisation; medical or surgical intervention to prevent permanent impairment; chronic disease; foetal distress, foetal death, or congenital impairment.

2. Field Safety Corrective Actions (FSCAs)​

All FSCAs — whether or not prompted by a specific incident — must be notified to MHRA. See When an FSCA is required.

3. Trend reports​

A statistically significant increase in the rate of non-individually-reportable events triggers a trend report. See Trend reporting.

The "could lead to" standard​

Reporting covers not only events that caused harm but events that could have caused serious harm. Near-misses where harm was avoided are reportable if the device malfunction could have caused death or serious deterioration had circumstances been slightly different.

Determining reportability: step-by-step​

  1. Did the device malfunction or underperform? If yes → proceed
  2. Could the malfunction be causally related to harm? If yes or possible → proceed
  3. Did it or could it lead to death or serious deterioration? If yes → report
  4. Does a valid exemption apply? See Exemptions from reporting
  5. Determine timeframe → See Reporting timeframes

When in doubt: report.

Who must report​

The manufacturer (or UKRP for non-UK manufacturers) bears the primary reporting obligation. Healthcare professionals and patients can report directly via the MHRA Yellow Card scheme.

Official references​

ReferenceDescription
UK MDR 2002, Regulations 16–22Vigilance reporting requirements
MHRA: Adverse incident reportingMHRA's primary vigilance guidance
MHRA: Yellow Cardyellowcard.mhra.gov.uk