Medical Device Registration in

Sweden

Ministry of Health

Ministry of Health and Social Affairs

Regulatory Authority

Medical Products Agency (MPA)

Medical Device Regulation

Regulation (EU) 2017/745

Official Language

Swedish

Classification

Class I, IIa, IIb and III

Registration Process

  • Determine the device classification
  • Appoint an Authorized Representative and Notified Body
  • 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.
  • Once approved, prepare a Declaration of Conformity.
  • The products can now be marketed in Sweden.

Documents Required

  • CE Certificate
  • Technical File
  • Declaration of Conformity
  • Clinical Evaluation Report (CER)
  • Risk Management File
  • QMS certificate
  • Label, IFUs and 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

Special Notes

Documents, and IFUs should be submitted in Swedish

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