Medical Device Registration in
Netherland
Ministry of Health:
Ministry of Health, Welfare and Sport
Regulatory Authority:
Health and Youth Care Inspectorate
Medical Device Regulation:
EU MDR 2017/745
EU IVDR 2017/746
Official Language:
Dutch
Classification:
Class I, IIa, IIb and III
Registration Process:
- Appoint Authorized Representative.
- Determine the class of the device.
- 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 files should be submitted to the Notified Body.
- Notified body audits manufacturer for Conformity Assessment and sends the report to the Competent Authority
- Once approved, the device can be marketed.
Documents Required:
- CE Certificate
- Technical File
- Declaration of Conformity
- Clinical Evaluation Report (CER)
- Risk Management File
- QMS certificate
- Labelling
Post-market Requirements:
- Serious public health threats – 2 day
- Death or serious health deterioration – 10 days
- Other serious incidents – 15 days
Applicable QMS:
ISO 13485
Registration Timeline:
Class I: 4-6 weeks
Others: Based on Notified Body timeline
Authorized Representative:
Yes
License Validity:
5 years
Special Notes:
Labels and IFUs should be in Dutch