| Regulatory Authority | Health and Youth Care Inspectorate |
|---|---|
| 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 |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Registration Process | Medical Device Registration | 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 Dutch Language |
| Adverse Event Reporting Form | Download |
| Additional Information | There is a registration obligation (notification obligation) for manufacturers or their authorised representatives established within the Netherlands that are placing a medical device, system or procedure pack on the market in the following class: Class I medical device Custom-made medical device In vitro diagnostic device (IVD) (all risk classes) |