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
Official Language:
French
Classification:
Class I, IIa, IIb and III
Medical Device Registration in Belgium:
- 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