Post-market overview & ongoing responsibilities
Post-market obligations under the UK MDR 2002 derive from multiple provisions of the Regulations, including Schedule 1 (Essential Requirements for PMS and clinical follow-up), Schedule 3 (conformity assessment surveillance obligations), and the specific vigilance reporting requirements. MHRA enforces post-market obligations actively through market surveillance and inspection.
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official legislation and MHRA guidance before making regulatory decisions.
Post-market compliance is not optional
Placing a device on the GB market is not the end of the manufacturer's regulatory obligations — it is the beginning of a new phase. Post-market compliance under UK MDR 2002 is a continuous, lifecycle-long obligation.
Manufacturers, UKRPs, importers, and distributors all have ongoing responsibilities once a device is on the market. Failure to meet post-market obligations can result in:
- MHRA enforcement action
- Mandatory recall
- Suspension or cancellation of UKAB certificates
- Criminal prosecution
- Reputational damage and civil liability
The post-market obligation landscape
Post-market obligations cluster into six areas:
| Area | Who is primarily responsible | Key obligation |
|---|---|---|
| Post-market surveillance (PMS) | Manufacturer | Proactive monitoring of real-world device performance |
| Vigilance reporting | Manufacturer / UKRP | Reporting serious incidents and trend data to MHRA |
| Field Safety Corrective Actions (FSCAs) | Manufacturer / UKRP | Taking corrective action in the field when safety issues arise |
| MHRA registration maintenance | Manufacturer / UKRP | Keeping registration current as devices and company details change |
| Labelling and advertising compliance | Manufacturer / distributor | Ensuring ongoing compliance with labelling and promotional rules |
| UKAB surveillance | Manufacturer | Participating in annual UKAB surveillance audits; maintaining certification |
Who bears post-market responsibilities
Manufacturers
Manufacturers bear the primary post-market obligations — PMS, vigilance reporting, FSCAs, technical file maintenance, and UKAB surveillance cooperation.
UK Responsible Persons (UKRPs)
UKRPs share post-market responsibilities with manufacturers for the GB market:
- Must transmit serious incident and FSCA reports to MHRA (on behalf of or alongside the manufacturer)
- Must maintain records and cooperate with MHRA investigations
- Must notify the manufacturer of any complaints or field reports received in GB
Importers
Importers must:
- Report devices presenting a serious risk to MHRA and to the manufacturer/UKRP
- Maintain records of imports (minimum 5 years, 15 years for implantables)
- Not continue to supply a device they know to be non-compliant
Distributors
Distributors must:
- Report devices suspected of presenting a serious risk to MHRA and to the manufacturer/UKRP
- Cooperate with any recall or FSCA
- Maintain traceability records
The feedback loop: post-market to pre-market
Post-market data does not exist in isolation — it must feed back into the pre-market evidence base:
Post-market surveillance data
Adverse event reports
PMCF study results
PSUR conclusions
│
▼
Risk management file update
(new hazards? changed risk estimates?)
│
▼
Clinical Evaluation Report update
(new clinical evidence? changed benefit-risk?)
│
▼
Technical file update
(revised ERs checklist, new test data if needed)
│
▼
UKAB notification if significant design change
A manufacturer who treats post-market surveillance as a compliance formality — rather than a genuine source of safety intelligence — is failing both their patients and their regulatory obligations.
MHRA's post-market enforcement tools
MHRA has a range of tools to enforce post-market compliance:
| Tool | Description |
|---|---|
| Market surveillance | MHRA can inspect devices on the market, request technical files and DoCs, and test devices |
| Manufacturer inspection | MHRA can inspect manufacturing premises and QMS records |
| Vigilance follow-up | MHRA investigates serious incident reports and may require corrective action |
| Recall powers | MHRA can mandate recall of devices presenting a serious risk |
| Enforcement notices | MHRA can issue notices requiring a manufacturer to take specific action |
| Prohibition notices | MHRA can prohibit the supply of a non-compliant device |
| Criminal prosecution | MHRA can prosecute for serious violations of the UK MDR 2002 |
| UKAB certificate suspension | MHRA can instruct a UKAB to suspend or withdraw a certificate |
Related pages
- Vigilance — what must be reported
- Vigilance — reporting timeframes
- Field Safety Corrective Actions
- Post-market surveillance by class
- Labelling requirements
- MHRA registration maintenance
Official references
| Reference | Description |
|---|---|
| UK MDR 2002 (SI 2002/618 as amended) | Post-market obligations throughout the Regulations |
| MHRA: Post-market surveillance guidance | MHRA's PMS guidance |
| MHRA: Adverse incident reporting | Vigilance reporting requirements |
| ISO 13485:2016, Clause 8 | Measurement, analysis, and improvement — post-market QMS |
| ISO 14971:2019 | Risk management — post-market risk monitoring |