Post-market — overview & ongoing obligations
Both MDR 2017/745 and IVDR 2017/746. Post-market obligations begin the moment a device is placed on the market and continue until the device is withdrawn from service.
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
CE marking is the beginning, not the end
A common misconception is that CE marking concludes a manufacturer's regulatory obligations. Under MDR and IVDR, CE marking is the start of the post-market phase — a lifecycle of ongoing obligations that must be actively managed.
The EU post-market framework reflects a fundamental principle: real-world performance may differ from what was established in pre-market studies, and the regulatory system must capture and act on those differences.
The five post-market obligation areas
| Area | Key obligation | Relevant section |
|---|---|---|
| Post-market surveillance | Proactively collect and analyse data on device performance | PMS |
| Vigilance | Report serious incidents and field safety corrective actions | Adverse event reporting |
| Field safety | Implement corrective actions where devices pose unacceptable risk | FSCAs |
| EUDAMED | Register and maintain device and operator information | EUDAMED |
| Labelling | Maintain compliant labelling and advertising | Labelling |
Who bears post-market obligations?
Manufacturers
Manufacturers bear the primary and fullest set of post-market obligations. These include all five areas above and are non-delegable in terms of accountability — even if specific activities are contracted to third parties, the manufacturer remains legally responsible.
Authorised representatives (EU REPs)
EU REPs of non-EU manufacturers:
- Are jointly and severally liable with the manufacturer for defective devices
- Must register in EUDAMED
- Must maintain a copy of the technical documentation and EU Declaration of Conformity
- Must cooperate with competent authorities in post-market activities
- Must immediately inform the manufacturer and competent authorities of safety concerns
Importers
Importers must:
- Verify CE marking before placing on the market
- Maintain records of complaints and non-conformities
- Cooperate with recalls and field safety corrective actions
- Inform the manufacturer and competent authorities of safety issues
- Not place a device on the market if they have reason to believe it is unsafe
Distributors
Distributors must:
- Verify CE marking before making available
- Maintain distribution records (enabling traceability for recall)
- Cooperate with recalls and FSCAs
- Inform the manufacturer, importer, and competent authority of safety concerns
- Not make available a device if they have reason to believe it is unsafe
Healthcare institutions
Healthcare institutions have specific obligations relating to:
- Storing UDI data for implanted devices
- Issuing implant cards to patients
- Reporting serious incidents they become aware of to competent authorities (in most member states)
- Reprocessing of single-use devices (Art. 17, where nationally permitted)
The post-market feedback loop
MDR and IVDR create a mandatory feedback loop between post-market experience and the technical documentation:
Post-market data collected (PMS)
↓
Analysed in PMS report / PSUR
↓
Evaluated in PMCF / PMPF evaluation report
↓
Fed back into Clinical Evaluation Report / Performance Evaluation Report
↓
Risk management file updated if new hazards or risk estimates change
↓
Notified body informed at surveillance audit
↓
CE certificate maintained, updated, or suspended
This loop means the technical documentation must be treated as a living set of documents, not a static archive produced once at CE marking.
Serious incident reporting — the immediate obligation
While PMS is a proactive, ongoing process, the vigilance system triggers specific immediate obligations when things go wrong. Manufacturers must report:
- Serious incidents to the relevant national competent authority within defined timeframes (15 or 30 days depending on urgency)
- Field safety corrective actions (FSCAs) to NCAs before implementation where possible
- Trend reports where statistically significant increases in non-serious incidents are detected (MDR Art. 88)
See Adverse event reporting for full detail.
Key regulatory references
| Obligation | MDR reference | IVDR reference |
|---|---|---|
| PMS system | Art. 83 | Art. 78 |
| PMS plan | Art. 84 | Art. 79 |
| PSUR | Art. 85 | Art. 80 |
| PMCF/PMPF | Art. 61(11), Annex XIV Part B | Art. 56, Annex XIII Part B |
| Serious incident reporting | Art. 87 | Art. 82 |
| FSCAs | Art. 89 | Art. 84 |
| Trend reporting | Art. 88 | Art. 83 |
| EUDAMED registration | Art. 28–31 | Art. 25–28 |
| Labelling | Annex I §23 | Annex I §20 |
Related pages
- PMS requirements
- What must be reported
- When an FSCA is required
- EUDAMED registration overview
- Labelling requirements
Official references
| Reference | Description |
|---|---|
| MDR Art. 83–92 | Post-market surveillance and vigilance chapter |
| IVDR Art. 78–87 | IVDR equivalent |
| MDR Art. 10 | General manufacturer obligations |
| MDR Art. 11–14 | EU REP, importer, distributor obligations |
| MDCG 2023-3 | Guidance on serious incident reporting |