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February 4, 2026
Approximately 5 minutes
Overview of In Vitro Diagnostic Medical Devices Regulation in Belgium
Overview of In Vitro Diagnostic Medical Devices Regulation in Belgium
1. Applicable Regulation and Transitional Provisions
The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) has been applicable since 26 May 2022. Transitional periods allow certain IVDs compliant with Directive 98/79/EC (IVDD) to remain on the market, with extensions and amendments to deadlines under Article 110 IVDR. Source: FAMHP IVD Page https://www.famhp.be/en/ivd
2. General Obligations for Manufacturers
Manufacturers must comply with general obligations under Article 10 IVDR, subject to applicability during transitional periods for legacy devices. Source: FAMHP IVD Page https://www.famhp.be/en/ivd
3. Registration as an IVD Manufacturer
Registration in Eudamed's Actors module is required under IVDR. It is voluntary until 28 May 2026 and mandatory thereafter (Decision (EU) 2025/2371). FAMHP encourages early registration. After obtaining a Single Registration Number (SRN), complete details via the FAMHP web portal. Source: FAMHP IVD Page https://www.famhp.be/en/ivd
4. Registration of IVDs
IVDs must be registered in Eudamed's Devices module. Registration is currently voluntary and becomes mandatory from 28 May 2026, with a six-month transitional encoding period. During transition, if not using Eudamed, Belgian manufacturers or authorised representatives notify FAMHP under national legislation transposed from IVDD. Voluntary Eudamed registration replaces FAMHP notification. For acknowledgement of receipt, contact FAMHP with specific details (SRN, Basic UDI-DI, etc.). After 28 May 2026, only Eudamed applies, and national notifications cease. Source: FAMHP IVD Page https://www.famhp.be/en/ivd
5. Notification to FAMHP (Transitional)
Until mandatory Eudamed use, notify FAMHP before or on the day of placing on the market using dedicated forms (IVDR or IVDD versions). Submit to notifications.meddev@afmps.be. Receipt confirmation does not imply approval of qualification, classification, or conformity. Significant changes must be reported within 15 days. Transition from IVDD to IVDR notification is treated as a new notification. Source: FAMHP IVD Page https://www.famhp.be/en/ivd
6. Transitional Period Details
Certain IVDs qualify as legacy devices under Article 110 IVDR, with extended periods via amendments in 2022, 2023, and 2024, including certificate validity to 26 May 2025 and removal of sell-off deadlines. Source: FAMHP IVD Page https://www.famhp.be/en/ivd
7. Guidance and Resources
European Commission guidance on UDI, Eudamed, nomenclature, and other topics is available. FAMHP provides an FAQ for IVD manufacturers and authorised representatives. Source: FAMHP IVD Page https://www.famhp.be/en/ivd
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