Ministry of Health

Ministry of Social Affairs and Health

Regulatory Authority

Finnish Medicines Agency (Fimea)

Medical Device Regulation

EU MDR 2017/745

Official Language

Finnish and Swedish

Classification

Class I, IIa, IIb and III

Registration Process

• 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 

Documents Required

• CE Certificate
• Technical File
• Declaration of Conformity
• Clinical Evaluation Report (CER)
• Risk Management File
• QMS certificate
• Label, IFU or User Manual

Post-market Requirements

• Serious public health threats – 2 day
• Death or serious health deterioration – 10 days
• Other serious incidents – 15 days

Applicable QMS

ISO 13485

Registration Timeline

Class I: 4-6 weeks

Others: Based on Notified Body timeline

Authorized Representative

Yes 

License Validity

5 years