Belgium Country Commercial Guide
Learn about the market conditions, opportunities, regulations, and business conditions in belgium, prepared by at U.S. Embassies worldwide by Commerce Department, State Department and other U.S. agencies’ professionals
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Medical Devices
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Overview

The $3.71 billion Belgian market for medical equipment and supplies is one of the most active and innovative in Europe. A key driver of this segment is the Belgium health care system – which is considered among the most extensive and efficient in Europe, serving the country’s entire population of 11.8 million inhabitants. Moreover, Belgium is for many companies a regional distribution center with more than two-thirds of medical device exports are sent to other countries within the European Union (EU). According to Fitch Solutions, Belgium’s market for medical devices is expected to grow by 5.8 percent between 2021 and 2026. There are excellent opportunities for companies specializing in digitization and e-health, as well as in innovative technologies and equipment that can improve quality of care and efficiency while reducing costs.   

The medical manufacturing industry in Belgium is relatively modest, with only around 50 companies producing medical devices. Few multinationals have major manufacturing operations in Belgium, while indigenous producers are on the small side or focused on niche markets. Most local manufacturers are small businesses employing less than 100 staff. Larger manufacturers include the medical imaging specialist Agfa HealthCare and Ion Beam Applications, which specializes in particle accelerator technology and cancer therapy. Aside from these two companies, medical manufacturing is focused on orthopedics and prosthetics and medical and surgical instruments and apparatus.

Since Belgium produces less than 10 percent of medical equipment consumed domestically, the market is open for heavy competition among suppliers from the U.S., Germany, France, and the U.K. According to the latest available figures in 2021, the U.S. is Belgium’s leading supplier, accounting for 21.1 percent of imports. U.S. companies supplied 37.1 percent of imported radiation apparatus, 42.4 percent of imported suturing materials, and 22 percent of orthopedics & prosthetics.

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.  elgium 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.

Over the next few years, major measures are expected to be introduced in Belgium to continue improving the quality of care and efficiency of the health system. Among them are a continuous reform of the hospital and mental health care structures, and of the integrated care projects, the development of a national health research system, the reform of the national fee schedule, and the implementation of a new law on quality practice in health care. Other prospects include innovative technologies and equipment that can help cut costs, diagnostic products to detect chronic diseases in their early stages, orthopedic products, homecare products, obesity and wound care products are in high demand.

Leading Sub-Sectors

Digitization

A recent survey done by beMedtech, a Belgian Association of medtech companies, shows that further digitalization of healthcare, the shift of care outside hospitals closer to the patient’s home setting and more value-based healthcare are considered top opportunities by the member companies. According to Belgium’s Foreign Trade Agency, industry associations including beMedtech, Agoria and ABDH (the Belgian Association of Hospital Managers) have launched an umbrella initiative called HealthTech.Belgium to spur the coordination and integration of public and private sector medical technology innovations vis-à-vis administrative automation, eHealth, mHealth, electronic patient records, and teleconsultation and telemonitoring platforms and portals.

Belgian authorities and industry recognize that artificial intelligence (AI) plays an essential role in the development of digital healthcare. Given this, AI is increasingly present in Belgian hospital infrastructures and healthcare professionals are increasingly willing to participate in AI projects with numerous potential applications including preventive medicine, diagnostic assistance, simplification of the patient pathway, patient flow prediction, and optimization of costs and resources.

E-Health

Covid 19 had a significant impact on the use of medical software, telemedicine, e-health, and m-health, especially during the first wave. 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. There is currently a strong push from the sector federation (bemedtech) to also apply the legal framework for digital therapeutics (DTx). DTx are evidence-based therapeutic interventions driven by software to prevent, manage, or treat a medical disorder or disease. They need to comply with the EU’s 2017/745 Medical Device Regulation.

Although there are several Belgian innovative companies offering DTx, there is still room for new DTx applications, such as in mental health care. There is a focus on RWD (Real World Data and Integrated care) but the landscape is very fragmented with hospitals using different internal systems. To realize the full potential of e-health and m-health, the overall healthcare ecosystem is in the process of being reformed. Swift data transfers between all stakeholders, such as hospitals, patients, public authorities, research institutes and industry, supported by an effective regulatory framework, can help the effective use of ‘big data’. A fully informed healthcare network provides for more coherent communication and efficient decision-making. Although e-Prescription and electronic records are finally implemented, there is still a need for interoperability, allowing healthcare providers to share patient information across platforms.

Doing Business in Belgium’s Medical Devices Sector

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.  As with all EU Member States, Belgium supports and implements the EU legal framework for regulating medicinal products for human use through its own set of national laws.  At a European level, medical devices are regulated by Regulation (EU) 2017/745 (the Medical Device Regulation). In Belgium, the Federal Agency for Medicines, and Health Products (FAMHP) is responsible for safeguarding the quality, safety and efficacy of medicines and pharmaceuticals for human and veterinary use, medical devices, and raw materials used for preparing and manufacturing medicines.

Belgian national measures to implement the Medical Device Regulation came into effect in May 2021, and consist of the law of 22 December 2020 on medical devices, accompanied by three royal decrees: the Royal Decree of 12 May 2021, which implements the provisions in the Belgian law of 22 December 2020; the Royal Decree of 18 May 2021, which sets out the provisions regarding clinical trials involving medical devices; and the Royal Decree of 28 April 2021, which aligns previous national rules with the Medical Device Regulation. Medical devices are classified according to risk into Classes I, IIa, IIb and III. The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device. Licenses issued in the EU are valid for five years. An authorized representative is required anywhere in the EU.

Medical devices must bear the CE marking for conformity when marketed. Custom-made implantable and non-implantable devices and devices for clinical investigation do not require CE marking. If a notified body has been involved in verifying the procedure of conformity, the CE mark must be accompanied by a four-digit number indicating the notified body. Information on CE Marking can be found here:

 https://single-market-economy.ec.europa.eu/single-market/ce-marking/manufacturers_en.

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.

Although U.S. exporters are not required to appoint a local agent or distributor to sell to Belgian companies or the Belgian government, it is strongly recommended that companies consider partnering with a local company for the purposes of monitoring business opportunities, navigating import and standard testing regulations, and identifying public sector sales and contract opportunities. The U.S. Commercial Service in Brussels can advise U.S. companies on finding local partners.  

Resources          

  • Federal Agency for Medicines, and Health Products (FAMHP) – responsible for safeguarding the quality, safety and efficacy of medicines and pharmaceuticals for human and veterinary use, medical devices, and raw materials used for preparing and manufacturing medicines
  • beMedtech – a Belgian Association of medtech companies
  • ABDH – the Belgian Association of hospital managers
  • Medica Duesseldorf, November 13-16, 2023
  • For more information, contact Commercial Specialist Danny Dumon at danny.dumon@trade.gov.