Medical Device Registration in
Sweden
Ministry of Health
Ministry of Health and Social Affairs
Regulatory Authority
Medical Device Regulation
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