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Netherland

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

Want to know more about this registration process?