Belgium - Medical Devices Belgium - Medical Devices
Overview
Belgium produces less than 10 percent of medical equipment consumed domestically. This leaves the market open for heavy competition among suppliers from the U.S., Germany, France and U.K. According to the latest available figures, the U.S. has a 28 percent share of total medical equipment imports into Belgium. U.S. suppliers are particularly 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 $2.5 billion in 2018. Over the past five years, this sector has seen an annual growth of approximately four 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:
| 2016 | 2017 | 2018 (Est.) | 2019 (Est.) | |
| Total Market Size | 2.2 | 2.4 | 2.5 | 2.6 |
| Total Local Production | 4.0 | 3.6 | 5.2 | 5.2 |
| Total Exports | 13.3 | 12.5 | 13.7 | 14 |
| Total Imports | 11.5 | 11.3 | 11 | 11 |
| Imports from the U.S. | 2.9 | 2.9 | 2.9 | 3 |
1 Euro = 1.1069 1.1297 1.1810 1.14
Source BMI
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.
Leading Sub-Sectors
Belgium’s healthcare system is currently facing several challenges. A growing elderly population and higher health expectations have had and will 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, homecare products, obesity 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, ehealth and mhealth are as a consequence sectors with a strong market potential. Belgium’s current nomenclature and reimbursement system is under revision and a legal framework will be put in place so that telemonitoring, medical apps, and wearable medical technologies can be used and reimbursed in the near future.
Opportunities
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 a large number of 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.
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.
From May 26, 2020, the new Regulation 2017/745/EU will fully apply to medical devices. Until this date, medical device manufacturers can choose to comply with either the Directives (93/42/EEC for medical devices and 90/385/EEC for active implantable medical devices or the Regulation. From May 26, 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/EEC) 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.
Patient access to over-the-counter medical devices will be significantly improved under a new regulation that will allow distribution through supermarkets and other stores for the first time. From February 2019, various medical devices that were only allowed to be sold in pharmacies will become available in supermarkets and other stores. The change mainly concerns sterile consumables such as bandages and probes.
Web Resources
Belgian Ministry of Health
http://www.fagg-afmps.be/en/human_use/health_products/medical_devices_accessories/
The Belgian Association of manufacturers and importers of medical devices
EU Medical Devices Legislation
https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en
REACH Directive
WEEE and RoHS Directives
Supplement of the Official Journal of the European Union
Medica Duesseldorf – November 18-21, 2019
International Fair for Medical Equipment