Medical Device Registration in
Ministry of Health:
Medical Device Regulation:
EU MDR 2017/745
EU IVDR 2017/746
Class I, IIa, IIb and III
- 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.
- CE Certificate
- Technical File
- Declaration of Conformity
- Clinical Evaluation Report (CER)
- Risk Management File
- QMS certificate
- Serious public health threats – 2 day
- Death or serious health deterioration – 10 days
- Other serious incidents – 15 days
Class I: 4-6 weeks
Others: Based on Notified Body timeline
Labels and IFUs should be in Dutch