Regulatory Requirements for Class I Medical Device Manufacturers in Belgium

1. General Obligations

Class I medical devices are the lowest risk class and generally do not require notified body intervention for CE marking. However, subcategories sterile (Is), measuring (Im), and reusable surgical instruments (Ir) require limited notified body assessment for specific aspects such as sterility, measurement function, or reprocessing. Manufacturers bear full responsibility for compliance with Regulation (EU) 2017/745 (MDR), effective since 26 May 2021. They must issue an EU Declaration of Conformity (Article 19 MDR) and fulfil general obligations under Article 10 MDR, including maintaining complete technical documentation. Non-EU manufacturers must appoint an EU authorised representative. Source: FAMHP Class I Medical Devices Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/class_i_medical

2. Registration in Eudamed

Manufacturers must register in the Actors module of Eudamed. Registration is voluntary until 28 May 2026 and mandatory thereafter (Decision (EU) 2025/2371). After obtaining a Single Registration Number (SRN), complete registration via the FAMHP web portal, specifying device risk classes and establishment units. Source: FAMHP Class I Medical Devices Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/class_i_medical

3. Device Registration and Notification

Class I devices must be registered in Eudamed's Devices module (voluntary until 28 May 2026, mandatory thereafter). During transition, Belgian manufacturers or authorised representatives must notify FAMHP no later than the day of placing on the market, using dedicated forms sent to notifications.meddev@fagg-afmps.be. From 28 May 2026, only Eudamed registration applies, and national notifications cease. Source: FAMHP Class I Medical Devices Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/class_i_medical

4. Subcategories Requiring Notified Body Involvement

For Class Is (sterile), Im (measuring), and Ir (reusable surgical instruments), a notified body assesses the relevant aspects (sterility, measurement, or reprocessing). Standard Class I devices do not require notified body intervention. Source: FAMHP Class I Medical Devices Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/class_i_medical

5. Post-Market Surveillance and Vigilance

During transition for devices under Directive 93/42/EEC, only MDR requirements for post-market surveillance, vigilance, and registration apply (Article 120(3) MDR; MDCG 2021-25). Source: FAMHP Class I Medical Devices Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/class_i_medical

6. Notification of Changes

Significant changes must be notified to FAMHP within 15 days using the notification form. Transition from MDD to MDR notification is treated as a new notification. Source: FAMHP Class I Medical Devices Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/class_i_medical

7. Transitional Provisions

Certain MDD-compliant Class I devices benefit from transitional arrangements under Article 120(3) MDR, allowing continued placement on the market with only specified MDR requirements applied. Source: FAMHP Class I Medical Devices Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/class_i_medical