Belgium Medical Device Regulations 2026: MDR Requirements and Market Access Guide
In Belgium, the regulation of medical devices is carried out by the Federal Agencies for Medical and Health Products (FAMHP).
Manufacturers planning to commercialize medical devices in Belgium in 2026 must comply with EU MDR 2017/745, meet EUDAMED registration requirements, and operate under the oversight of Belgium’s national competent authority. Belgium is a strategically important EU market, offering strong clinical research infrastructure and central geographic access to Europe. Regulatory expectations under MDR are significantly more rigorous than under the former Directives, and 2026 marks a critical year as EUDAMED mandatory obligations come into force.
Who Regulates Medical Devices in Belgium
Medical devices in Belgium are regulated by the Federal Agency for Medicines and Health Products (FAMHP). FAMHP is responsible for market surveillance and inspections, vigilance and incident reporting, clinical investigation approvals, and enforcement of EU MDR at the national level.
CE Marking Under EU MDR
CE marking under EU MDR is mandatory to place a medical device on the Belgian market. Devices are classified as Class I, IIa, IIb, or III based on risk. Class I devices that are non-sterile, have no measuring function, and are not reusable surgical instruments may be self-declared by the manufacturer. All other classes require Notified Body involvement in the conformity assessment process. Additional requirements include a robust Quality Management System, expanded clinical evaluation, and ongoing post-market surveillance. Once CE marked, devices may circulate freely across all EU and EEA markets.
EUDAMED Registration: A Critical 2026 Milestone
From May 28, 2026, EUDAMED registration is mandatory for four confirmed functional modules: economic operator registration, UDI and device registration, Notified Bodies and certificates, and market surveillance. Prior to this date, registration remains voluntary.
From May 28, 2026, manufacturers must register as an economic operator in EUDAMED, obtain a Single Registration Number (SRN), and upload UDI and device information as required. Non-EU manufacturers must appoint an EU Authorized Representative, who holds legally defined responsibilities under MDR.
Manufacturers should also monitor ongoing European Commission efforts to simplify the MDR and IVDR frameworks, as targeted amendments may affect compliance obligations in the coming years.
Language Requirements
Belgium has three official languages: Dutch, French, and German. Labeling and Instructions for Use must comply with the language requirements of the region where the device is marketed. Non-compliance can delay market access or trigger corrective action.
Clinical Investigations
Clinical investigations in Belgium must comply with MDR requirements. Applications are submitted to FAMHP, Ethics Committee approval is required, and sponsors must meet MDR safety reporting timelines. Belgium is a well-established clinical research environment, but all documentation must align with MDR standards.
Post-Market Surveillance and Vigilance
Post-market obligations under MDR are actively monitored by FAMHP. Manufacturers must maintain a documented Post-Market Surveillance plan, Periodic Safety Update Reports for Class IIb and III devices (Class IIa devices have separate periodic reporting requirements under MDR Article 86), UDI-based traceability, Field Safety Corrective Action procedures, and timely serious incident reporting.
Key Takeaways for 2026
To successfully commercialize a medical device in Belgium, manufacturers should confirm full EU MDR compliance, obtain valid CE marking, complete EUDAMED registration ahead of the 28 May 2026 deadline, appoint an EU Authorized Representative if located outside the EU, meet Belgian language requirements, and implement structured post-market surveillance and vigilance processes. Proactive regulatory planning and centralized compliance data management are essential for maintaining market access as MDR enforcement matures.
