Belgium - Country Commercial Guide
Medical Devices

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2021-11-11


Belgium produces less than 10 percent of medical equipment consumed domestically.  This leaves the market open for heavy competition among suppliers from the United States., Germany, France, and U.K.  According to the latest available figures, the United States has a 26 percent share of total medical equipment imports into Belgium.  U.S. suppliers are dominant in the sectors of diagnostic imaging apparatus, orthopedic and implantable products, and medical and surgical instruments.

The Belgian market for medical equipment and supplies is estimated at $2.8 billion in 2020.  Over the past 5 years, this sector has seen an annual growth of approximately 4 percent.  The Belgian Social Security System, which includes the Health Care System, is considered among the most extensive and efficient in Europe.  It covers nearly 100 percent of the population of 11 million inhabitants. 

Following data are in billions of dollars:






2020 (E)


2021 (F)


Total Market Size





Total Local Production





Total Exports





Total Imports





Imports from the U.S.





Sources Fitch Solutions

Differentials can be explained by the fact that Belgium is a large transshipment hub.  Belgium is for many companies a regional distribution center and more than two-thirds of medical device exports are sent to other countries within the EU.

Sub-Sector Best Prospects

Belgium’s healthcare system is currently facing several challenges.  A growing elderly population, a growing number of chronically ill people and higher health expectations have an important impact on healthcare expenditures in the coming years.  In this context, the government is looking at various cost-saving measures. Thus, innovative technologies and equipment offering cost savings will have a strong market potential. Diagnostic products to detect chronic diseases in their early stages, orthopedic products, services and technologies for home assistance, wound care and diabetes products are in high demand.

Furthermore, there is a trend towards treating chronic diseases with new technologies allowing patients to stay home and minimizing the impact on their quality of life.  Medical software, telemedicine, e-health and m-health are as a consequence sector with a strong market potential and were used during the first wave of Covid-19.  The success of m-health resulted in a legal framework allowing the reimbursement of all mobile health applications from prevention to diagnosis and aftercare, providing they comply with certain standards such as CE mark and Privacy.


Belgium is an effective entry point and base for marketing medical equipment to the rest of Europe due to its geographical location, its effective healthcare system, and its relatively open attitude regarding procurement.  Belgium is a distribution center for many multinationals: products are imported into Belgium and exported to other European countries.  Consequently, the value of the Belgian medical imports is significantly higher than the value of the market itself.

Belgium is also home to many HealthTech start-ups.  Traditionally, the HealthTech sector has many spin-offs, but new businesses no longer have to have a research background to be successful.  Nonetheless, universities, knowledge centers, and university hospitals remain fertile ground for new entrepreneurship in health.  However, many health startups often find it difficult to develop the business model at an international level and to source risk and growth capital. 

A new financing system forced hospitals to create networks with other hospitals, allowing them to invest in the latest technologies for diagnostics and therapies.  Furthermore, personalized medicine is gaining more attention.  The Health Minister recently launched a new initiative aimed at optimizing the use of modern DNA analysis techniques (next-generation sequencing) in cancer prevention.  The launch of the “data for better health” initiative, which looks at how the enormous amount of clinical data can be used to improve the effectiveness of diagnostics and treatment, is getting more traction.

In order to enter the medical equipment market in Belgium, American suppliers should be familiar with the EU directives concerning the registration, marketing, and health/safety standards required throughout Europe as well as regulations specific to Belgium.  It is therefore advisable to work with a local partner/distributor. 

Since 26 May 2021, the new Regulation 2017/745/EU fully applies to medical devices.  The MDR replaces the existing Directives for medical devices (93/42/EEC and 90/385/EEC).  From 26 May 2022, the new Regulation 2017/746/EU will fully apply to in-vitro diagnostics.  Until this date, IVD manufacturers can choose to comply with either the Directive (98/79/EC) or the Regulation.

The European Directive 2004/18/EC on public procurement applies to all hospitals for the purchase of medicines and medical devices.  The directive requires that for purchases over the threshold of €200,000, a European tender should be released and published in the supplement of the Official Journal of the European Union.  Procurement with a threshold between €85,000 and €200,000 requires a tender in Belgium and publication in the Official Journal.

Trade Promotion Opportunities

Medica Duesseldorf – November 2022 (International Fair for Medical Equipment