How to report — national competent authorities
Regulatory basis - MDR Art. 87 / IVDR Art. 82 require reports to be submitted to the NCA of the member state(s) where the incident occurred. EUDAMED is the primary reporting platform; some NCAs also accept or require national-format reports.
Disclaimer - 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.
EUDAMED — the primary reporting platform
The EUDAMED vigilance module is the central electronic platform for EU vigilance reporting. It enables:
- Submission of serious incident reports to one or multiple NCAs simultaneously
- Submission of FSCA notifications and field safety notices
- Tracking of report status and NCA responses
- Data sharing between NCAs across member states
Manufacturers must register in EUDAMED (obtain an SRN) before using the vigilance module. See EUDAMED vigilance module.
Which NCA(s) to report to
For serious incidents
Report to the NCA of each member state where the incident occurred. If it is unclear which member state(s) are affected, report to the NCA of the member state where the device is predominantly marketed or where the manufacturer's EU REP is based, and clarify jurisdiction in the report.
For FSCAs
Report to the NCA of each member state where the affected device is on the market — not only where incidents occurred. The FSCA typically spans all markets where the device is distributed.
Non-EU manufacturers
Non-EU manufacturers report through their EU authorised representative. The EU REP submits reports to the relevant NCA(s) on the manufacturer's behalf. Internally, the EU REP must be informed of any serious incident or FSCA as soon as the manufacturer becomes aware.
National competent authorities — key contacts
| Country | NCA | Website |
|---|---|---|
| Germany | BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) | bfarm.de |
| France | ANSM (Agence nationale de sécurité du médicament) | ansm.sante.fr |
| Italy | Ministero della Salute | salute.gov.it |
| Spain | AEMPS (Agencia Española de Medicamentos) | aemps.es |
| Netherlands | IGJ (Inspectie Gezondheidszorg en Jeugd) | igj.nl |
| Sweden | MPA (Läkemedelsverket) | lakemedelsverket.se |
| Poland | URPL (Urząd Rejestracji Produktów Leczniczych) | urpl.gov.pl |
| Ireland | HPRA | hpra.ie |
| Belgium | FAMHP (Federal Agency for Medicines and Health Products) | famhp.be |
| Austria | BASG / AGES | basg.gv.at |
A full list of all EU NCAs is maintained on the European Commission DG SANTE website.
Report content — structured fields in EUDAMED
EUDAMED vigilance reports use structured data fields. Key fields include:
Device identification
- Basic UDI-DI / UDI-DI
- Lot or serial number of the affected unit(s)
- Manufacturer name and SRN
Incident description
- Date of incident
- Date manufacturer became aware
- Location (member state, healthcare institution type)
- Description of the incident — what happened
- Patient outcome (death / serious deterioration / near-miss / unknown)
- Number of patients/users affected or potentially affected
Device involvement assessment
- Is the device the primary cause? Contributing factor? Unknown?
- Was the device returned for analysis?
Actions taken
- Immediate actions (device removal, patient notification)
- Any FSCA triggered by this incident
Bilateral reporting obligations — some member states
Certain member states have additional national reporting requirements that run in parallel with EUDAMED reporting. Before the EUDAMED vigilance module was fully operational, many NCAs had national web portals or email systems. Manufacturers should check with each relevant NCA whether national-format reports are also required.
Acknowledgement and follow-up by NCAs
After a report is submitted:
- The NCA acknowledges receipt (within EUDAMED or by direct communication)
- The NCA may request additional information, clarification, or supporting documentation
- For FSCA notifications, the NCA may request changes to the field safety notice before it is distributed to users
Manufacturers should maintain an internal log of all vigilance communications with NCAs, including report submission confirmations, NCA queries, and manufacturer responses.
Coordinated reporting for multi-country incidents
For incidents or FSCAs affecting multiple member states:
- EUDAMED allows a single report to be flagged as relevant to multiple member states
- The NCAs involved may coordinate their review through EUDAMED or bilaterally
- The manufacturer should be prepared to respond to queries from multiple NCAs
- One NCA may take a coordinating role (often the NCA of the member state where the manufacturer or EU REP is based)
Related pages
Official references
| Reference | Description |
|---|---|
| MDR Art. 87 | Reporting obligation — NCA |
| IVDR Art. 82 | IVDR equivalent |
| MDR Art. 101 | EUDAMED as the reporting platform |
| MDCG 2023-3 | Serious incident reporting guidance |
| EC DG SANTE | NCA directory |