Medical device manufacturer's incident report
- Permit or other obligation
- Nationwide
- Public service
Incident reporting procedure according to the MD and IVD Regulation
The incident reporting procedure pursuant to Medical Devices Regulation (EU) 2017/745 (MD Regulation) is applied to medical devices in compliance the Regulation and to devices placed on the market pursuant to Article 120(3) (‘legacy devices’, MDCG 2021-25).
The incident reporting procedure pursuant to In Vitro Diagnostic Med ...
Do the following
The notice shall be sent by e-mail to meddev.vigilance@fimea.fi. The notice can also be sent by fax at +358 29 522 3002 or by post.
An incident report shall be submitted using the address:
Finnish Medicines Agency (Fimea)
Medical devices
Mannerheimintie 166
PO Box 55
FI-00034 Helsinki, Finland
In urgent cases, the reporting may be made by telephone at +358 29 522 3341, but a written report shall also always be filed without delay.
To whom and on what terms
The service is intended for medical device manufacturers.
Deadline
### Incident reporting for devices under the Directive: * Serious public health threat: within 2 days from receipt of information * Death or unexpected serious deterioration in health: within 10 days * Other cases: within 30 days from receipt of information ### For MDR/IVDR devices: * Serious threat: immediately, no later than 2 days from receipt of information * Death or unexpected serious deterioration in health: within 10 days * Other serious cases: within 15 days from receipt of information