Medical Device Registration in
Ministry of Health
Ministry of Social Affairs and Health
Finnish Medicines Agency (Fimea)
Medical Device Regulation
EU MDR 2017/745
Finnish and Swedish
Class I, IIa, IIb and III
- Obtain CE Marking certificate.
- Appoint Authorized Representative.
- Determine class of the device.
- Class I device can be Self-Certified. QMS necessary but Notified Body intervention is not required.
- For other classes, prepare a CE Technical File
- Obtain and register UDI in EUDAMED.
- Technical File should be audited by Notified Body.
- Prepare a Declaration of Conformity.
- Once approved, the device can be marketed in Finland
- CE Certificate
- Technical File
- Declaration of Conformity
- Clinical Evaluation Report (CER)
- Risk Management File
- QMS certificate
- Label, IFU or User Manual
- Serious public health threats – 2 day
- Death or serious health deterioration – 10 days
- Other serious incidents – 15 days
Class I: 4-6 weeks
Others: Based on Notified Body timeline