Medical Device Regulation in Belgium
Belgium regulates medical devices under the EU Medical Device Regulation (EU MDR 2017/745). The Federal Agency for Medicines and Health Products (FAMHP/AFMPS) serves as the national competent authority. Belgium is home to several EU notified bodies and plays an active role in the EU medical device regulatory landscape.
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Device Classification
Belgium follows the EU MDR classification system. Class I devices are low risk (e.g., non-sterile bandages, reusable surgical instruments). Class IIa devices are low-moderate risk (e.g., hearing aids, diagnostic ultrasound). Class IIb devices are moderate-high risk (e.g., infusion pumps, radiotherapy equipment). Class III devices are high risk (e.g., drug-eluting stents, prosthetic heart valves). Classification follows Annex VIII of EU MDR.
Official classification guidance →Official Guidance Documents
Official guidance from Belgium's competent authority covering device registration, notification, and regulatory obligations for medical devices.
Instructions for reporting serious incidents and field safety corrective actions for medical devices in Belgium.
The EU-wide database for medical device registration, UDI assignment, and certificate management.
Standards & Key Principles
Applicable Standards
Key Principles
- Medical devices must bear the CE mark under EU MDR 2017/745 to be placed on the Belgian market.
- Manufacturers must register devices in EUDAMED and comply with UDI requirements.
- Notified body involvement is required for Class IIa, IIb, and III devices.
- Non-EU manufacturers must designate an authorized representative within the EU.
- Clinical evaluations must be conducted and maintained throughout the product lifecycle.
Pre-Market Requirements
Devices must comply with EU MDR 2017/745 and bear the CE mark. Class IIa, IIb, and III devices require involvement of an EU-notified body for conformity assessment.
Full technical documentation per EU MDR Annexes II and III is required, covering device description, design verification, risk management, biocompatibility, and clinical evidence.
A clinical evaluation must be performed for all devices per EU MDR Article 61. Class III and implantable devices typically require clinical investigations.
Manufacturers and authorized representatives must notify FAMHP of devices placed on the Belgian market, in addition to EUDAMED registration.
Post-Market Requirements
A post-market surveillance system must be established per EU MDR Article 83. PSURs are required for Class IIa, IIb, and III devices.
Serious incidents must be reported to FAMHP per EU MDR Article 87. Field safety corrective actions and field safety notices must also be communicated.
Ongoing PMCF activities are required to continuously validate the clinical safety and performance of devices throughout their intended lifetime.
International Recognition & Reliance
CE-marked devices approved under EU MDR are accepted across all EU/EEA member states, including Belgium.
CE-marked devices from EU member states are recognized in Switzerland under the MRA framework with applicable conditions.