Reporting timeframes
Reporting timeframes are in Regulations 16–22 of the UK MDR 2002 (as amended by SI 2019/791). The clock starts from the date the manufacturer becomes aware of the incident — not from the date of occurrence.
Timeframe table
| Event type | Timeframe | Clock starts |
|---|---|---|
| Serious public health threat | Immediately — no later than 2 calendar days | Date of awareness |
| Death or unanticipated serious deterioration | No later than 10 calendar days | Date of awareness |
| Other reportable serious incident | No later than 30 calendar days | Date of awareness |
| FSCA notification | No later than 10 calendar days from FSCA decision | Date FSCA decided |
| Trend report | No later than 30 calendar days after trend identified | Date trend identified |
Staged reporting: initial, progress, and final
MHRA accepts that investigations take time. Reports are staged:
Initial report — submitted within the statutory timeframe, with information known at the time. Investigations need not be complete.
Progress reports — submitted at 30-day intervals (or as agreed with MHRA) while investigations continue.
Final report — submitted when the root cause investigation is complete, describing findings and CAPAs implemented.
Do not wait for the investigation to be complete before filing the initial report. Filing late because "the investigation wasn't finished" is a reporting obligation violation.
When awareness is established
The clock starts when the manufacturer's quality/regulatory team receives and processes the complaint or event notification — not when the event occurred in the field. All incoming complaints must be date-stamped and triaged rapidly. A robust complaint intake process is essential to meeting these timeframes.
Related pages
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Regulations 16–22 | Timeframe requirements |
| MHRA: Adverse incident reporting guidance | Implementation guidance on timeframes |