As an EU Member State, Belgium doesn’t run its own separate rulebook for medical devices. Medical devices placed on the Belgian market fall under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) and CE marking is treated as the entry ticket. What Belgium does add is a national layer on top of that EU base. Most of it runs through FAMHP, known elsewhere as AFMPS or FAGG. Notification, economic operator registration, vigilance reporting and market surveillance all run through this agency.
In this article we’ll walk through where the EU rules end and the Belgian-specific ones begin, including the EUDAMED changes that became mandatory on 28 May 2026.
Regulatory Authorities for Medical Devices in Belgium
Two layers of authority govern medical devices in Belgium. Manufacturers who treat them as one and the same usually pay for it later.
Federal Agency for Medicines and Health Products (FAMHP / AFMPS)
Under both MDR and IVDR, FAMHP is the body Belgium designates as its competent authority for medical devices. Each EU Member State names one such body to run market surveillance and related work under the Regulations. In Belgium’s case, that’s FAMHP.
Its confirmed responsibilities include:
- Registering and processing device notifications where these still apply
- Coordinating vigilance and materiovigilance alongside manufacturers, and other EU competent authorities
- Running market surveillance, which can extend to ordering an unsafe device off the market
- Administering distributor and importer registration through its web portal
- Collecting the annual contribution and turnover tax that keep Belgian medical device oversight funded
European Commission
The European Commission owns the MDR and IVDR texts and issues Medical Device Coordination Group (MDCG) guidance that interprets them across all Member States. It does not process Belgian national registrations; that is FAMHP’s job.
Other Belgian Authorities
When devices come into Belgium from outside the EU, it’s Belgian Customs and Excise (under FPS Finance) that handles the customs paperwork and import declarations, not FAMHP.
Belgium Medical Device Classification
Belgium Medical Device Classification follows the EU system in full. There is no independent Belgian classification scheme for MDR-regulated devices. Under MDR Annex VIII, devices fall into four risk-based classes:
- Class I – lowest risk (examples: non-sterile bandages, manual wheelchairs)
- Class IIa – low-to-medium risk (examples: hearing aids, dental fillings)
- Class IIb – medium-to-high risk (examples: infusion pumps, ventilators)
- Class III – highest risk (examples: heart valves, implantable pacemakers)
Class I devices with special features (sterile “Is”, measuring “Im”, reusable surgical “Ir”) need limited Notified Body involvement even though the base class is low risk. FAMHP’s own Class I guidance confirms that, unlike Classes IIa, IIb and III, Notified Body intervention is not always required for Class I devices to be placed on the market and CE marked.
Classification drives everything downstream. Whether a Notified Body is involved, how much clinical evidence is expected, how detailed the technical documentation needs to be and what post-market obligations apply.
Authorized Representative (EC REP) Requirements in Belgium
Companies established outside the EU need an EU Authorized Representative before their device can reach the EU market, Belgium included, under MDR Article 11. This is an EU-level requirement rather than a Belgium-specific one. The EC REP doesn’t need to be located in Belgium. Any EU-established Authorized Representative satisfies Article 11.
The written mandate between manufacturer and EC REP, laid out under MDR Article 11(3), must cover at minimum:
- Verifying that the EU Declaration of Conformity and technical documentation exist and stay current
- Keeping technical documentation and Notified Body certificates available for the competent authority
- Cooperating with FAMHP and other competent authorities on corrective actions
- Forwarding requests from patients and users
- Terminating the mandate if the manufacturer fails its MDR Article 10 obligations
MDR Article 13 sets similar obligations for importers. There’s also a PRRC requirement under Article 15, and it isn’t limited to manufacturers alone, importers (when relevant) and Authorized Representatives need one too. MDCG guidance, specifically MDCG 2022-16 and MDCG 2019-7, elaborates on both roles. The EC REP’s name and address must appear on the device label under MDR Annex I.
Medical Device Regulatory Guidelines in Belgium
Getting Belgium Medical Device Regulatory Requirements straight starts here, with the reference order a manufacturer entering this market should follow.
- Regulation (EU) 2017/745 (MDR) and, where applicable, Regulation (EU) 2017/746 (IVDR)
- European Commission guidance and MDCG documents
- FAMHP/AFMPS guidance published on famhp.be
- Then there’s Belgian law itself, mainly the Law of 22 December 2020 on medical devices, its three implementing Royal Decrees from 2021 (28 April, 12 May, 18 May), and the separate Law of 15 June 2022 for IVDs.
Belgium operates inside the EU medical device system rather than running a parallel one. Where Belgian national law adds something, such as economic operator registration or language requirements, it does so within the space the MDR and IVDR leave open for Member States to legislate.
Medical Device Registration Process in Belgium
The point that trips people up most is that CE marking and Belgian registration or notification are not the same regulatory action. Medical Device CE Marking Belgium relies on demonstrating MDR conformity at EU level. FAMHP notification and EUDAMED registration are how Belgium and the EU database know that the device and company exist. In general, both are required, on separate timelines.
Step 1: Determine the device classification under MDR Annex VIII. Get this right first; it decides almost every step that follows.
Step 2: Confirm the product is in scope of the MDR (or IVDR) and identify which regulatory requirements apply to it specifically.
Step 3: Complete the applicable conformity assessment. Self-declaration is available for most Class I devices; everything else needs Notified Body involvement under MDR Annex IX, X or XI, depending on the route chosen.
Step 4: Prepare technical documentation as per MDR Annex II (general technical documentation) and Annex III (post-market surveillance documentation).
Step 5: Complete clinical evaluation under MDR Article 61 and Annex XIV, proportionate to device risk.
Step 6: Establish Quality Management System. ISO 13485 is the standard manufacturers use in practice to demonstrate MDR Article 10 QMS obligations.
Step 7: Appoint an EU Authorized Representative, if the company is established outside the EU.
Step 8: Register in EUDAMED. Two systems apply here and the date matters. Before 28 May 2026, manufacturers placing a Class I device or IVD on the Belgian market had to notify FAMHP directly. That was the rule, unless the device was already registered in EUDAMED voluntarily. From 28 May 2026 onward, that changed. Manufacturers, Authorized Representatives, importers, and system or procedure pack producers now register in EUDAMED’s Actors module instead. Devices themselves go into a separate module, the UDI/Devices module. One exception exists. IVDs already on the market get a six-month grace period before this applies to them.
Step 9: Register distributors and importers with FAMHP, where applicable. Distributors don’t register in EUDAMED at all. The Royal Decree of 15 November 2017 has them registering directly on the FAMHP web portal instead. Importers work differently. They register through EUDAMED’s Actors module, not through FAMHP. The route depends on the operator type, so it’s worth checking FAMHP’s current guidance before filing.
Step 10: Meet Belgian labelling and language requirements.
Step 11: Place the device on the Belgian market, with manufacturer, importer and distributor obligations under MDR Articles 10, 13, and 14 all active simultaneously.
Step 12: Maintain post-market surveillance and vigilance for the life of the device, reporting to FAMHP where required.
Required Documents for Medical Device Registration in Belgium
Not every document below goes to FAMHP directly. Some demonstrate MDR conformity and simply need to be retained and produced on request.
Documents that demonstrate MDR conformity (retained by the manufacturer):
- EU Declaration of Conformity (MDR Article 19)
- Technical documentation and risk management file (MDR Annex II, III)
- Clinical Evaluation Report
- QMS documentation, typically built to ISO 13485
Documents connected to Belgian/EU registration:
- EC REP written mandate (where applicable)
- Economic operator registration data submitted to EUDAMED’s Actors module or, for distributors, the FAMHP portal
- UDI and device data submitted per the applicable EUDAMED module
- FAMHP notification records, for the categories and transitional period where this still applies
Documents retained and produced to FAMHP on request:
- PMS Plan and PMS/PSUR reports under MDR Articles 83-86
- Vigilance and incident-reporting records
MDR Articles 10-16 set the economic operator obligations behind this documentation, Article 19 covers the Declaration of Conformity, and Articles 27-31 cover UDI and registration duties.
QMS Requirements for Medical Devices in Belgium
Belgium does not operate a separate Belgian Quality Management System (QMS) standard. Article 10 sets the QMS bar, and it scales with the device. Manufacturers need a system proportionate to risk class and device type, one that covers design controls, supplier management, production controls, complaint handling, CAPA, post-market surveillance and vigilance.
In practice, ISO 13485 is what manufacturers reach for to prove this. Notified Bodies tend to expect it for Class IIa devices and up, under MDR Annex IX. ISO 13485 certification itself is not automatically a Belgian legal requirement for every device.
Class I self-declared devices are not obliged to hold third-party QMS certification, though a documented QMS proportionate to risk is still expected under Article 10.
Belgium Medical Device Labelling Requirements
Belgium is trilingual. Three languages hold official status here, Dutch, French and German, and nothing shapes Belgian labelling more than that fact.
The Law of 22 December 2020 confirms this for labels and IFUs, while allowing English for devices intended solely for professional use. The Law of 22 December 2020 confirms this for labels and IFUs, while allowing English for devices intended solely for professional use.
Placement requirements for the key information:
| Information Element | Required Location |
| CE mark, UDI, manufacturer name and address | Label and packaging |
| EC REP name and address (for non-EU manufacturers) | Label |
| Warnings and required symbols | Label and/or IFU |
| Complete instructions for use | IFU, in applicable Belgian languages |
| EU Declaration of Conformity | Retained by manufacturer and produced to FAMHP on request |
Registration Timelines for Medical Devices in Belgium
Registration Timelines for Medical Devices in Belgium depend on:
- Device classification and whether a Notified Body is involved
- Notified Body queue and workload, which the MDR itself does not fix a statutory period for
- Readiness of technical documentation and clinical evidence
- Whether the applicable registration route is EUDAMED (post-28 May 2026) or the prior national FAMHP notification for transitional categories
- Completeness of the submitted registration or notification information
Belgium Medical Device Registration Fees
Belgium Medical Device Registration Fees are governed by the Law of 20 July 2006 on the creation and operation of FAMHP, Articles 14/2 to 14/6, and are published annually by FAMHP. The financing system has two components, according to FAMHP’s official fees page:
- An annual contribution for economic operators, calculated using a per-entity cost that FAMHP sets each year
- An annual turnover tax, calculated as a percentage of Belgian medical device turnover, with an exemption below an indexed turnover threshold
Distributors who register and confirm compliance with FAMHP’s self-check guide can be exempted from the economic operator contribution. Separately, FAMHP charges a fee for electronic Certificates of Free Sale.
Beyond FAMHP’s own fees, manufacturers should budget separately for Notified Body fees, testing costs, clinical evaluation, QMS certification, translation into the three Belgian languages and regulatory consulting support.
Belgium Medical Device Import Requirements
Belgium Medical Device Import Requirements combine MDR obligations with ordinary customs procedure.
On the regulatory side, MDR Article 13 sets the checklist. Importers must confirm the manufacturer is identified. They must also confirm the EC REP, if the device has one. The device needs a valid CE mark. UDI assignment has to be completed. Labelling and the IFU must meet MDR Annex I, plus Belgian language rules. All of this happens before the device reaches the Belgian market.
Relabelling or repackaging triggers a separate rule, Article 16. FAMHP’s distributor guidance is clear on this. Notify FAMHP before market placement. A Notified Body certificate confirming QMS compliance follows within 28 days, submitted through the FAMHP portal.
Customs works differently. Import declarations, tariff classification and duty treatment all fall under Belgian Customs and Excise, part of FPS Finance, not FAMHP.
Belgium Medical Device Post-Market Surveillance
Belgium Medical Device Post-Market Surveillance is an EU MDR obligation that continues after CE marking and Belgian market entry. MDR Articles 83–92 set the framework:
- A documented PMS system and PMS Plan proportionate to device risk
- A PMS Report for Class I devices and Periodic Safety Update Reports (PSURs) for Class IIa and above under MDR Article 86
- Vigilance: serious incident reporting and Field Safety Corrective Actions (FSCAs), reported to FAMHP as Belgium’s competent authority
- Trend reporting and corrective action where patterns emerge from complaint data
FAMHP registers incoming vigilance notifications and uses them for Belgian market surveillance, which can range from communicating with hospitals and healthcare professionals to ordering withdrawal of a device, according to FAMHP’s own glossary guidance. FAMHP also coordinates with other EU competent authorities and the European Commission on cross-border vigilance matters. Specific reporting deadlines for serious incidents and FSCAs are set at MDR level (Article 87) and MDCG guidance.
Conclusion
Belgium runs entirely inside the EU MDR/IVDR system. CE marking remains the foundation, and no separate Belgian classification scheme exists alongside it. What Belgium adds is a national layer, made up of FAMHP oversight, a shifting EUDAMED/FAMHP registration route and trilingual labelling that needs early planning.
If you need support with medical device registration, CE marking, technical documentation, FAMHP requirements, or Belgian market entry, reach out to the experts at info@artixio.com for guidance tailored to your product and market entry goals.
FAQs
Q1. Is medical device registration required in Belgium?
Yes. Economic operators and devices must be registered, either through FAMHP’s national portal (for distributors, and historically for certain notifications) or through EUDAMED, which became mandatory for manufacturers, Authorized Representatives, importers and system or procedure pack producers from 28 May 2026.
Q2. Does Belgium require CE marking for medical devices?
Yes. CE marking under the EU MDR, or IVDR for in vitro diagnostics, is mandatory for placing a device on the Belgian market, just as it is across the EU.
Q3. What is FAMHP Medical Device Registration and what’s FAMHP’s role?
FAMHP acts as Belgium’s competent authority under the MDR and IVDR. It handles national notification and registration for certain operators and devices, coordinates vigilance and materiovigilance, runs market surveillance, and administers the annual contribution and turnover tax system for medical device economic operators.
Q4 What are the FAMHP Notification Requirements?
Placing a Class I device or IVD on the Belgian market used to require direct FAMHP notification, unless the device was already registered voluntarily in EUDAMED. Since the 28 May 2026 transition, manufacturers, Authorized Representatives, importers and system or procedure pack producers register through EUDAMED’s Actors and UDI/Devices modules instead. Distributors still register directly with FAMHP rather than through EUDAMED, following the Royal Decree of 15 November 2017.
Q5. Do non-EU medical device manufacturers need an EC REP in Belgium?
They need an EU Authorized Representative under MDR Article 11, which is an EU-level requirement rather than a Belgium-specific one. The EC REP does not need to be based in Belgium itself. It only needs to be established somewhere in the EU.
