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.