| Regulatory Authority | Federal Agency for Medicines, and Health Products (FAMHP) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | EUMDR-2017/745 | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Registration Process | Registration of distribution and import activities | 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 French and Dutch and German Language |
| Database | EUDAMED | Click Here |
| Adverse Event Reporting Form | Download |
| Additional Information | For low-risk classes, no prior notified body approval is needed, except for sterile devices and reusable surgical instruments. Custom-made devices, systems, and procedure packs do not need CE marking, but must be approved by a notified body if they are not compatible or if the manufacturer wants to extend the use of their device to other indications. |