Medical Device Registration in
Ministry of Health
Medical Device Regulation
Class I, IIa, IIb and III
- 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.
- CE Certificate
- Technical File
- Declaration of Conformity
- Clinical Evaluation Report (CER)
- Risk Management File
- QMS certificate
- Label, IFUs and 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
Documents, and IFUs should be submitted in Swedish