Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
February 2, 2026
Approximately 5 minutes
Regulatory Requirements for Systems and Procedure Packs in Belgium
Regulatory Requirements for Systems and Procedure Packs in Belgium
1. Definitions
Regulation (EU) 2017/745 (MDR) Article 2 defines:
- Procedure pack: a combination of products packaged together and placed on the market to be used for a specific medical purpose.
- System: a combination of products, packaged together or not, intended to be inter-connected or combined to achieve a specific medical purpose. Systems and procedure packs may include CE-marked medical devices, in vitro diagnostics, or other compliant products. Source: FAMHP Systems and Procedure Packs Guidance https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/systems_and_procedure
2. Obligations under Article 22 MDR
Natural or legal persons combining CE-marked devices (including IVDs under Regulation (EU) 2017/746 or other compliant products) must draw up a statement confirming:
- The combination is compatible with the original intended purposes.
- It respects limits of use specified by manufacturers. This applies when placing the system or procedure pack on the market. Source: FAMHP Systems and Procedure Packs Guidance https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/systems_and_procedure
3. Registration as Producer
Producers register in the Actors module of Eudamed (currently voluntary). Registration becomes mandatory 6 months after Eudamed is fully functional. FAMHP encourages early registration, as Eudamed will be the primary source for actor data. Source: FAMHP Systems and Procedure Packs Guidance https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/systems_and_procedure
4. Registration of Systems and Procedure Packs
Registration in Eudamed's Devices module is currently voluntary and becomes compulsory no later than 18 months after actor registration is mandatory (total 24 months after full Eudamed functionality). During transition, Belgian producers (or authorised representatives) notify FAMHP before or on the day of placing on the market if not using Eudamed. Voluntary Eudamed registration replaces FAMHP notification. For acknowledgement of receipt, contact FAMHP with specific details (Actor ID, SRN, Basic UDI-DI, etc.). Source: FAMHP Systems and Procedure Packs Guidance https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/systems_and_procedure
5. Transitional Notification to FAMHP
Under Royal Decree of 18 March 1999 Article 10, producers not using Eudamed must notify FAMHP using the dedicated form (available in French/Dutch), submitted no later than the day of placing on the market, separately for each system/procedure pack. Send to notifications.meddev@afmps.be. Receipt confirmation does not imply approval of qualification, classification, or conformity. Source: FAMHP Systems and Procedure Packs Guidance https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/systems_and_procedure
6. Changes and Updates
Significant changes to notification information must be reported to FAMHP within 15 days using the applicable form. Source: FAMHP Systems and Procedure Packs Guidance https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/systems_and_procedure
7. Additional Guidance
Further guidance on medical devices is available on the European Commission website. Source: FAMHP Systems and Procedure Packs Guidance https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/systems_and_procedure
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Regulatory Requirements for Class I Medical Device Manufacturers in Belgium
Manufacturers of Class I medical devices in Belgium must fully comply with the MDR (EU) 2017/745, register in Eudamed, notify FAMHP during the transition period until May 2026, issue an EU Declaration of Conformity, maintain technical documentation, and fulfil post-market surveillance obligations, with specific rules for sterile, measuring, and reusable surgical subcategories.
Approximately 5 minutes
Overview of In Vitro Diagnostic Medical Devices Regulation in Belgium
The FAMHP oversees in vitro diagnostic medical devices (IVDs) in Belgium under Regulation (EU) 2017/746 (IVDR), applicable since 26 May 2022, with transitional provisions from Directive 98/79/EC and phased Eudamed registration requirements until mandatory in 2026.
Approximately 5 minutes
Application Procedure for Free Sales Certificates in Belgium
In Belgium, Free Sales Certificates (FSCs) for medical devices and IVDs are issued by FAMHP electronically since February 2025, with applications submitted by email using specific forms, a fee of €283.66 per certificate in 2026, limits on devices per certificate, and required supporting documents including conformity declarations and transitional proofs where applicable.
Approximately 5 minutes
Procedure for Requesting Exceptional Use of Non-CE Marked Medical Devices in Belgium
In Belgium, FAMHP authorizes exceptional use of non-CE marked medical devices or IVDs under MDR Article 59 or IVDR Article 54 when justified by public health or patient safety needs, with no suitable alternatives available and significant expected benefit, via compassionate use for individual patients or national derogation.