Under the EU Medical Device Regulation (MDR), vigilance plays a key role in patient safety and transparency in the MedTech industry. EUDAMED serves as the central platform for submitting these reports. This article provides an overview of the different types of vigilance reports that manufacturers must be aware of and comply with.
Vigilance is a reactive system within a manufacturer’s Post-Market Surveillance (PMS). It defines how the company handles incidents and corrective actions, aiming to minimize risks and prevent recurrence.
Once the vigilance module becomes mandatory, all reports must be submitted via EUDAMED, regardless of risk class or product type. The reporting obligation is defined in MDR Articles 87 to 92 and includes six types of reports.
MIR – Manufacturer Incident Report
Manufacturers must report serious, unexpected incidents, including side effects that are previously unknown, undocumented, and not covered in trend reports.
Reporting deadlines:
- General serious incident: within 15 days
- Incident causing death or serious deterioration of health: within 10 days
- Public health threat: within 2 days
Reports may be submitted incomplete to meet deadlines and updated later. If unsure whether an incident is reportable, it is recommended to report it proactively. MIRs are submitted only to the Competent Authorities (CAs).
If a manufacturer deems an incident not significant enough for an MIR or already expected it, they may omit the report but must justify this to the CA. If the CA disagrees, an MIR is still required.
Legal basis: MDR Art. 87 & 89(5)
FSCA – Field Safety Corrective Action
An FSCA report usually follows an MIR and must be submitted before implementing corrective actions, unless urgent action is needed.
Contents:
- Risk assessment
- Description of planned corrective actions
The CA evaluates the report based on:
- Public health protection
- Causality and recurrence probability
- Frequency of product use
- Severity and detectability of harm
- Clinical benefit and affected user groups
Legal basis: MDR Art. 87 & 89(5)
FSN – Field Safety Notice
The FSN is a public notice to users of the affected product. It informs about the FSCA and must be approved by the CA unless urgent.
Required information:
- Clear product identification (incl. UDI)
- Manufacturer’s SRN
- Description of the risk and malfunction
- Actions users must take
FSNs are submitted either as preliminary (to the CA) or final (publicly released).
Legal basis: MDR Art. 89(8)
PSR & PSRP – Periodic Summary Report & PSR Update Analysis Report
A PSR can replace multiple MIRs if:
- Incidents are similar and
- The cause is known or
- Incidents are frequent and well-documented or
- An FSCA has already been implemented
Use of a PSR must be agreed upon with the CA. Updates are submitted via the PSRP.
Legal basis: MDR Art. 87(9)
MTR – Manufacturer Trend Report
MTRs address statistically significant increases in non-serious incidents or expected side effects. Unexpected serious incidents still require an MIR.
Contents:
- Strategy for handling incidents
- Methodology for detecting statistical trends
- Observation period (as per PMS plan)
The CA may conduct its own assessments and request actions from the manufacturer. Results are shared with the EU Commission, other CAs, and the Notified Body.
Legal basis: MDR Art. 88
Summary
Vigilance reporting is not only a regulatory obligation but also a key element of product safety and trust in medical technology. Manufacturers who understand the different report types and their requirements can ensure timely and compliant submissions via EUDAMED—contributing to patient safety and quality assurance in the EU.
For more on PSUR, PMS, and Market Surveillance, see our article on vigilance under the MDR.
| Report Type | Abbreviation | Summary |
|---|---|---|
| Manufacturer Incident Report | MIR | Report serious incidents within 2/10/15 days. |
| Field Safety Corrective Action & Field Safety Notice | FSCA & FSN | Describe corrective actions and inform users. |
| Periodic Summary Report & PSR Update Analysis Report | PSR & PSRP | Bundle incidents instead of submitting individual MIRs. |
| Manufacturer Trend Report | MTR | Report statistically significant increases in incidents. |
| Periodic Safety Update Report | PSUR | Annual/semi-annual benefit-risk assessment. |