Incident reports

‘Incident’ means 

• any malfunction or deterioration in the characteristics or performance of a medical device, including use-error due to ergonomic features; 
• any inadequacy in the information supplied by the manufacturer; and 
• any undesirable side-effect.

See the definition of an incident in the Regulations:

MDR: Article 2(64) (EUR-Lex);

IVDR: Article 2(67) (EUR-Lex)

Medical Devices Act (719/2021) 33§ (EUR-Lex).

‘Serious incident’ means an incident that directly or indirectly led, might have led or might lead to any of the following:

1. the death of a patient, user or other person;
2. the temporary or permanent serious deterioration of a patient's, user's or other person's state of health;
3. a serious public health threat.

It should be noted that the situation caused by the device did not have to actually occur, it is enough that it could have happened. 

See the definition of a serious incident in the Regulations:

MDR: Article 2(64) (EUR-Lex);

IVDR: Article 2(67) (EUR-Lex).

Professional user:

Report the incident to Fimea and the manufacturer/authorised representative/importer/distributor.

See “Vaaratilanteista ilmoittaminen” (Reporting of incidents) for more information.

Manufacturer:

The procedure depends on the incident and the legislation applied to the device.

See “Manufacturer's incident reporting procedure” for more information.

Importer:

Report the incident to the manufacturer and the manufacturer’s authorised representative.

Distributor:

Report the incident to the manufacturer and, where appropriate, to the manufacturer’s authorised representative and the importer.

Authorised representative:

Report the incident to the manufacturer.

The procedure depends on the incident and the legislation applied to the device. 
Incidents concerning devices under the Directive and the Regulation are reported to Fimea using the MIR form.
Similar serious incidents concerning the same device or device type can be reported as a periodic summary report (PSR) instead of reporting individual serious incidents, provided that the root cause has been identified or a field safety corrective action implemented or the incidents are common and well documented. Incidents and expected undesirable side effects (MD) or expected erroneous results (IVD) must be reported as a trend report. 

See “Manufacturer's incident reporting procedure” for more information.

Professional users can report incidents to Fimea either with through the Fimea electronic interface used by the organization or sending a PDF form below to: [email protected].

Medical Device Professional User’s Incident Report (pdf)

Finnish Medicines Agency
Medical Devices
Mannerheimintie 166, 00300 Helsinki
P.O. Box 55, FI-00034 FIMEA, FINLAND

In urgent cases, the notification can first be made by phone (029 522 3341). However, the notification must also be submitted in a written format without delay.

Further information: Social and health care devices – Reporting of incidents

The requirements of the incident reporting procedure for medical devices depend on the type of the medical device concerned and the regulatory basis on which the device was placed on the market. Incidents related to MDD/IVDD devices and the serious incidents related to MDR/IVDR devices are reported to FIMEA via MIR form.

• Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD), Comission webpage
• Instructions for filling the form: Helptext
• Hint: if the form does not open in your browser, download it on your computer and open it with a PDF reader.

MIR form 7.3.1
The MIR form is being updated to version 7.3.1, but its mandatory implementation has been postponed. For now, the use of version 7.3.1 is voluntary. The form will still undergo updates and revisions before the final version is published on the European Commission’s website, which is expected during 2025. Mandatory implementation will begin after a four-month transition period following the publication date.

Fimea recommends that manufacturers monitor the Commission’s website to prepare for implementation. The site will publish schedules, different file formats of the form, and guidance.

Other incident reports for manufacturers can be found under “Manufacturer's incident reporting procedure”.