Skip to main content
NL
FR
EN
Other information and services:
www.belgium.be
Your medicine and health products
About the FAMHP
Jobs
Publications
Press
Contact
Complaints
Webportal
Search
Home
Human use
Veterinary use
Information for the public
Information for professionals
Home
Human use
Health Products
Current Page:
Medical devices and their accessories
Medical devices and their accessories
Generalities
What is a device
Legislation
Regulation 2017/745 + 2017/746
CE marking
Procedures scientific and technical-advice
Borderline products
Advertising, premiums, advantages and samples
Eudamed
Materiovigilance
Definition
What shall be notify?
Who should notify?
When must incidents be notified?
How should incidents be notified?
FSN
Clinical investigations and performance studies
Medical devices and active implantable medical devices
In vitro diagnostic medical devices (IVD) )
Manufacturers
Class I medical devices
Custom Made Devices
Systems and Procedure Packs
Devices class IIa, IIb, III
In vitro diagnostic medical devices (IVD)
Clinical Investigations and performance studies
Certificates of free sale
Request for exceptional use
Fees based on the turnover made in Belgium and payments
Health Applications
Self-checking guides
Distributors, importers and exporters
Free SalesCertificates (FSC)
Good Distribution Practice
Registration of distribution and import activities
Fees based on the turnover made in Belgium and payments
Health Applications
Self-checking guides
Health institutions and healthcare professionals
Devices manufactured and used only within health institutions ('in-house' devices)
Request for exceptional use
Reprocessing single-use medical devices
Sterilisation, cleaning and disinfection
Patients and users of devices
Advice on the proper use of devices
Device traceability
Meaning of symbols (device and packaging)
Medical device packaging
Informed consent
Glossary
Notified bodies
Consultation procedures for notified bodies
Last updated on 10/07/2023
For full functionality of this site it is necessary to enable JavaScript.
Here are the
instructions how to enable JavaScript in your web browser
.