Norway follows EU MDR and IVDR requirements under the EEA framework
| Regulatory Authority | Norwegian Medical Products Agency (NOMA) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Guidance and regulations - Norwegian Medical Products Agency | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Registration Process | Norwegian register for devices and EUDAMED | 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 Norwegian Language |
| Database | Norwegian Register for Medical Devices_ | Click Here |
| Additional Information | The registration requirement does not apply to foreign manufacturers and authorized representatives who place equipment on the Norwegian market through a Norwegian importer or distributor. Distributors and importers also have no registration obligation. |