Field safety notices (FSNs)
Regulatory basis - MDR Art. 89(3) / IVDR Art. 84(3). A field safety notice (FSN) is the communication issued by a manufacturer to inform customers, distributors, and users of an FSCA and what action they need to take. MDCG 2023-3 provides a template.
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.
What is a field safety notice?
A field safety notice (FSN) is the formal written communication from a manufacturer (or EU REP on their behalf) to all affected customers and users, notifying them of:
- The safety issue that has been identified
- The FSCA being taken
- The specific action required from the recipient
The FSN is issued concurrently with or immediately after notifying the NCA(s) of the FSCA. It is the primary tool for communicating safety information to the field.
Who receives the FSN?
The manufacturer must send the FSN to all direct customers who received the affected devices — typically:
- Hospitals, clinics, and healthcare institutions
- Distributors and importers
- In some cases: individual patients (for home-use or patient-held devices)
Distributors and importers who receive the FSN must pass it on to their own customers if they have further distributed the affected devices. The FSN must reach all entities in the distribution chain down to the actual user.
Required content of an FSN
MDCG 2023-3 provides a recommended FSN template. An FSN must contain:
| Element | Content |
|---|---|
| Identifier | Unique FSN reference number; issue date |
| Urgency | "Field Safety Notice — urgent" designation where applicable |
| Device identification | Trade name, model numbers, UDI-DI, affected lot/serial numbers or date ranges |
| Description of the problem | Plain-language explanation of the safety issue |
| Risk to patients/users | What harm could result if no action is taken |
| Action required | Precisely what the recipient must do (return device, stop use, apply update, inspect, etc.) |
| Timeline | When the required action must be completed |
| How to proceed | Contact details for returns, replacements, software updates, etc. |
| Manufacturer contact | Name, address, phone, email for queries |
| Regulatory awareness | Statement that NCAs have been notified; NCA reference number(s) if available |
| Acknowledgement request | Request for recipient to confirm receipt and compliance (where applicable) |
Language requirements
FSNs must be issued in the official language(s) of each member state where the affected device is marketed. A single English-only FSN is generally not sufficient for distribution to French, German, Spanish, Italian, or other-language markets.
For urgent FSCAs, an initial English-language notice may be issued first (with immediate NCA notification) while translations are being completed, provided translated versions follow rapidly.
FSN review by NCAs
NCAs may review draft FSNs before distribution, particularly for:
- Major product recalls
- Situations involving significant patient safety risk
- Cases where the NCA has questions about the scope or adequacy of the FSCA
If the NCA requests changes to the FSN, the manufacturer should incorporate these before final distribution. The NCA may withhold acknowledgement of the FSCA notification until satisfied with the FSN content.
Tracking FSN distribution and compliance
Manufacturers must track:
- Who received the FSN: maintain a record of all distribution channels and recipients
- Acknowledgement of receipt: request confirmation from recipients (especially for high-risk FSCAs)
- Compliance rates: what percentage of affected devices have been accounted for, returned, or modified
- Non-responsive recipients: follow up with customers who have not acknowledged or complied
NCA vigilance reports and EUDAMED updates should reflect the progress of FSN distribution and FSCA compliance.
EUDAMED — FSN upload
The FSN document is uploaded to EUDAMED as part of the FSCA notification. It becomes accessible to NCAs across the EU, supporting coordinated multi-country oversight of FSCAs affecting the EU market.
Related pages
- When an FSCA is required
- Recalls — classification & coordination
- Competent authority-initiated actions
- EUDAMED vigilance module
Official references
| Reference | Description |
|---|---|
| MDR Art. 89(3) | FSN requirement |
| IVDR Art. 84(3) | IVDR equivalent |
| MDCG 2023-3 | FSN template and guidance |
| MDR Art. 11(5) | Importer obligation to pass on FSNs |
| MDR Art. 14(5) | Distributor obligation to pass on FSNs |