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