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.