Medical Device Regulatory Requirements in Sweden
| Regulatory Authority |
Swedish Medical Products Agency |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Medical Devices Regulation
| Click Here
|
| IVD Classification |
A,B,C,D |
| Registration Process |
Registration of operators and devices
| Click Here
|
| Registration Timeline |
For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Swedish Language |
| Adverse Event Reporting Form |
Download |
| Additional Information |
Until Eudamed is in place, registration of economic operators established in Sweden and their devices must take place with the Swedish Medical Products Agency (Swedish MPA). |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025