Incident reports

Incident reports

This website contains information about reporting an incident. Before sending an incident report, please check the following:

  1. Does the observed event meet the definition of an incident?
  2. Who should be notified of the incident?
  3. What form should be used for reporting the incident?

What is an incident caused by a medical device?

‘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); IVDR: Article 2(67)


What is a serious incident?

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

  • the death of a patient, user or other person;
  • the temporary or permanent serious deterioration of a patient's, user's or other person's state of health;
  • 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(65); IVDR: Article 2(68).


Who should be notified of the incident?

  • 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.

Manufacturer’s incident reporting procedure

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.


Incident report forms

Incident report by a professional user

Professional users can report incidents to Fimea either with an electronic incident report form or sending a PDF form to: laitevaarat@fimea.fi.

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

 

Manufacturer’s incident report (MIR)

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