Market surveillance & enforcement
Regulatory basis - MDR Art. 93–97 / IVDR Art. 88–92. Market surveillance is the system of NCA activities that ensures devices on the EU market comply with MDR/IVDR requirements. It is distinct from — but complementary to — the manufacturer's own post-market surveillance system.
Disclaimer - This site provides general information only and does not constitute legal or regulatory advice.
Market surveillance vs. post-market surveillance
These are two distinct but complementary systems:
| System | Who runs it | Purpose |
|---|---|---|
| Post-market surveillance (PMS) | Manufacturer | Proactively collect and analyse data on device performance |
| Market surveillance | National Competent Authorities | Verify that devices on the market comply with MDR/IVDR; investigate non-compliance; take enforcement action |
NCAs conduct market surveillance through their own initiative and in response to vigilance reports, complaints, and signals from other NCAs or the MDCG.
NCA roles by member state
Each EU member state designates a national competent authority responsible for medical device market surveillance. All NCAs have equivalent powers under MDR/IVDR but may have different national enforcement approaches and resources.
| Country | NCA |
|---|---|
| Germany | BfArM |
| France | ANSM |
| Italy | Ministero della Salute |
| Spain | AEMPS |
| Netherlands | IGJ |
| Sweden | MPA |
| Ireland | HPRA |
| Belgium | FAMHP |
| Poland | URPL |
A full list is maintained on the European Commission DG SANTE website.
Market surveillance activities
NCAs conduct market surveillance through:
Proactive surveillance
- Documentary inspections: reviewing CE marking documentation, technical files, labelling, and Declaration of Conformity — without physically inspecting the device
- Device sampling and testing: purchasing devices from the market and testing against their specifications
- Unannounced inspections: attending manufacturer or distributor premises without advance notice
- EUDAMED monitoring: reviewing vigilance reports, FSCA notifications, and device registration data
Reactive surveillance
- Investigating complaints: following up on complaints from users, healthcare institutions, or other economic operators
- Responding to vigilance reports: investigating serious incidents reported by manufacturers
- Acting on FSCA notifications: verifying that manufacturers implement FSCAs effectively
- Cross-border coordination: sharing information with other NCAs through EUDAMED and direct communication
Safeguard procedures — Art. 95–97 MDR
When an NCA determines that a device presents an unacceptable risk, it may take restrictive measures and must notify other NCAs and the Commission through EUDAMED.
| Procedure | Trigger | Outcome |
|---|---|---|
| Art. 95 | Device presents unacceptable risk or is non-compliant | NCA orders corrective action, restriction, or withdrawal |
| Art. 96 | Formal objection process where manufacturer contests NCA action | NCA reconsiders; Commission may arbitrate |
| Art. 97 | NCA measure is contested or needs EU-wide application | Commission reviews; may impose EU-wide restrictive measure |
Non-compliant device actions
Where a device is found to be non-compliant or to present unacceptable risk, NCAs may:
- Issue a warning or non-compliance notice to the manufacturer or economic operator
- Order the device removed from the market (recall)
- Prohibit placement on the market
- Suspend clinical investigations using the device
- Refer the case to national enforcement or criminal authorities (for serious non-compliance)
NCAs also communicate non-compliant device findings to other NCAs and the MDCG, enabling coordinated EU-wide responses.
Cross-border coordination — SCENIHR and MDCG
Where a safety issue has implications across multiple member states, coordination occurs through:
- EUDAMED: shared vigilance and market surveillance data
- MDCG: strategic coordination on significant cross-border issues
- Bilateral NCA communication: direct information sharing between NCAs
Exporting non-CE-marked devices
A device without CE marking generally cannot be placed on the EU market, but may be exported to non-EU markets where it has been approved under local requirements. Manufacturers must comply with the importing country's requirements and must not use the absence of EU market authorisation to circumvent safety standards.
Related pages
- Competent authority-initiated actions
- What must be reported
- Regulatory framework overview
- Non-EU & third-country access
Official references
| Reference | Description |
|---|---|
| MDR Art. 93–97 | Market surveillance powers and procedures |
| IVDR Art. 88–92 | IVDR equivalent |
| MDR Art. 10(12) | Manufacturer duty to cooperate |
| EC Blue Guide 2022 | Market surveillance principles for EU products |