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Belgium

Medical Device Registration in Belgium

Ministry of Health: 

Federal Public Service, Health, Food Chain Safety and Environment 

Regulatory Authority:         

Federal Agency for Medicines and Health Products (FAMHP)

Medical Device Regulation:

EU MDR 2017/745

Royal Decree

Official Language:   

French 

Classification:          

Class I, IIa, IIb and III

Registration Process:          

  • Appoint Authorized Representative and Notified Body.
  • Determine 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 File should be audited by Notified Body.
  • Once approved, prepare a Declaration of Conformity.

Documents Required:        

  • CE Certificate
  • Technical File
  • Declaration of Conformity
  • Clinical Evaluation Report (CER)
  • Risk Management File
  • QMS certificate
  • Labelling

Post-market Requirements:        

Adverse event report,

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:          

IFUs or Labels to be in French

Want to know more about this registration process?