In MHRA’s Great Britain guidance, a post-market surveillance report (PMSR), a periodic safety update report (PSUR) and vigilance reporting serve different tasks. PMSR and PSUR updates summarise surveillance information; vigilance addresses specified incidents, trends and corrective actions. A report’s update cycle, an MHRA request deadline and a serious-incident notification are different clocks. Manufacturer-system guidance; vigilance guidance
What the guidance says about geographical scope
MHRA’s scope page says the requirements apply to devices placed on the market or put into service in Great Britain from 16 June 2025, including CE- and UKCA-marked devices. Great Britain means England, Scotland and Wales; it should not be used interchangeably with the whole UK. Requirements vary with the device and its conformity-assessment basis. Introduction and scope
The page describes itself as guidance and directs readers to legislation for the authoritative position. We checked the original, as-made SI 2024/1368, which inserts the post-market surveillance provisions into the Medical Devices Regulations 2002. That original text is separate from a consolidated account of current law or later amendments. Original instrument, regulations 1–4
PMSR and PSUR summarise different device groups
A post-market surveillance report (PMSR) and a periodic safety update report (PSUR) are reports arising from the manufacturer’s surveillance system. The table compares selected device groups and recurring update frequencies described in MHRA’s guidance and the original instrument.
| Report or device group | Minimum update frequency in MHRA’s guidance |
|---|---|
| PMSR: Class I general devices; general legacy IVDs and IVD classes A/B | Every 3 years |
| PSUR: Class IIa general devices | Every 2 years |
| PSUR: Class IIb and III general devices; active implantable devices | Every year |
| PSUR: legacy Annex II list A/B IVDs and IVD classes C/D | Every year |
Sources: MHRA report tables, original regulations 44ZL and 44ZM.
IVD means in vitro diagnostic device. The guidance distinguishes modern IVD classes from legacy Annex II lists; it should not be reduced to a single classification scheme. Custom-made devices and certain system or procedure packs have separate provisions outside this summary.
The original instrument also sets first-report deadlines from placement on the market or putting into service, whichever is sooner: 3 years for a PMSR, 2 years for a Class IIa PSUR and 1 year for other PSURs. The table summarises recurring updates; it does not determine an individual model’s first reporting date. Regulations 44ZL(3) and 44ZM(6)–(8), inserted by regulation 4
MHRA says the latest PMSR or PSUR must be supplied on request within 3 working days; there is no routine submission requirement to MHRA for those reports unless requested. This is a response period, separate from the report’s update cycle. Report types, exceptions and update tables
Submission to an approved body is a separate requirement: regulation 44ZM(9) says manufacturers must send the PSUR and its updates to the device’s approved body, if there is one. Regulation 44ZR also allows the Secretary of State to extend a three-working-day request period where considered reasonable. Approved-body submission and request extensions
Serious incidents have a different clock
MHRA’s vigilance guidance calls for immediate notification when a manufacturer becomes aware that its device may have caused or contributed to a reportable incident. The original regulation links immediate submission to establishing a causal or reasonably possible causal relationship. It also sets maximum periods after awareness of the relevant incident or threat. MHRA reporting timescales, regulation 44ZH(3)–(5)
| Serious-incident category | Maximum period stated in the guidance |
|---|---|
| Serious public-health threat | 2 calendar days |
| Death or unanticipated serious deterioration in health | 10 calendar days |
| Other serious incidents | 15 calendar days |
These are maximum periods, not instructions to wait. The guidance says uncertainty or incomplete information should not delay the initial report beyond the relevant timeframe. A universal “15-day reporting rule” would omit the shorter periods. Incident reporting timescales
Periodic safety reporting and a report about a serious incident therefore answer different questions: one reviews accumulated surveillance evidence, while the other concerns a specified event or signal.
A report is not a finding of compliance
MHRA’s scope guidance notes that its explanation does not address every requirement. The tables here organise selected documented distinctions; they do not classify an individual device or decide whether a manufacturer has met its obligations. Scope and guidance limits
The vigilance page also distinguishes GB incident forms from the EU form used for incidents in Northern Ireland. That geographical distinction remains relevant even though MHRA receives both through its reporting environment. Reporting routes
Our FDA guidance-priorities reporting covers a different jurisdiction and regulatory task. US guidance plans do not establish Great Britain’s surveillance requirements.