Medical Device Distributors in Belgium

Belgium — market overview

Belgium is approximately €3 billion in annual medical device sales. Despite the small geography, the country presents a distinct medical device market characterized by language fragmentation (Dutch in Flanders, French in Wallonia, German in the eastern cantons) and a strong public-private hospital split. Belgian medical device distribution is generally sophisticated — many pan-European manufacturers headquarter their Benelux operations in Belgium, and Brussels-based distributors often cover Luxembourg and into Northern France. Manufacturers entering Belgium typically use either a Benelux-wide partner or a Belgium-specific distributor with language coverage.

Regulatory framework

Medical devices in Belgium are regulated by FAMHP (Federal Agency for Medicines and Health Products / AFMPS / FAGG). EU MDR and IVDR apply. Belgian-specific reporting through the Mevro database is required for distributors.

Reimbursement decisions for hospital-administered devices are made by RIZIV/INAMI (National Institute for Health and Disability Insurance). Outpatient devices may require listing on specific reimbursement schedules.

Hospital procurement: Mercurhosp and regional groups

Mercurhosp is the major hospital purchasing organization covering a network of Belgian hospitals. Regional purchasing groups operate in both Flanders and Wallonia. University hospitals (UZ Brussel, UZ Leuven, UZ Gent, Cliniques Saint-Luc, CHU Liège) tend to run their own procurement.