FAMHP · Europe

Belgium medical device regulatory resources

Every Belgium dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources23/25 topics with recordsAug 2026 fees reviewed

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Medical device regulation news

Follow recent Federal Agency for Medicines and Health Products (FAMHP) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary FAMHP risk class with official rule references.

Government registration fees

Review current FAMHP application, review, and renewal fees.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Belgium requirements.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 39 source-linked facts →

23 of 25 research dimensions currently covered · 31 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified

Competent authority: The Federal Agency for Medicines and Health Products (FAMHP / AFMPS) is designated by national law as the competent authority for medical devices within the meaning of Article 101 of Regula…
Authority responsible for notified bodies: FAMHP is also designated as the authority responsible for notified bodies under Article 35 of Regulation (EU) 2017/745 (and Article 31 of Regulation (EU) 2017/746).

2 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

National implementation framework for MDR/IVDR: Belgium implemented the MDR nationally through the Law of 22 December 2020 on medical devices, with the Royal Decrees of 28 April 2021 (modifying/withdrawing provisions), 12 May 2021 (imple…
National penalties for device-law infringements: The Law of 22 December 2020 provides five sanction levels for infringements; level 5 is a criminal fine of EUR 2,000 to 200,000 plus imprisonment of two to five years. Level is raised one n…

2 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

In-house devices: national implementation of MDR Art. 5(5): Belgium implements the in house exemption (MDR Art. 5(5)) through the Royal Decree of 12 May 2021 (medical devices) and the Royal Decree of 14 September 2022 (IVDs), which specify the decla…

1 source-linked fact

Checked 2026-08-25

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D04

Classification rules

Verified

EU MDR classes I, Is, Im, Ir, IIa, IIb and III: Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III

1 maintained scheme

Checked 2026-08-26

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D05

Registration pathways

Verified

National distributor registration on the FAMHP web portal: Distributors of medical devices must register on the FAMHP web portal under Article 4 of the Royal Decree of 15 November 2017 on the notification of a materiovigilance contact point within…
In-house device declaration: mandatory dates: Registration of in house devices via the FAMHP web portal (declaration of manufacture) is mandatory since 26 May 2021 for in house medical devices and since 26 May 2024 for in house in vitr…

3 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

NMPA certificate does not replace EU conformity assessment: statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce…
EU CE under MDR/IVDR — single market validity: target: geo:bel · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…

2 source-linked facts

Checked 2026-09-15

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D07

Economic-operator roles

Verified

Relabelling/repackaging importers and distributors: FAMHP information duty: Importers and distributors that relabel or repackage devices (MDR/IVDR Art. 16(2)(a) and (b)) and intend to make them available on the Belgian market must inform the FAMHP and submit a cert…

1 source-linked fact

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Importers: EUDAMED Actors registration replaces national registration: Since 28 May 2026, importers of medical devices must register in EUDAMED in the 'Actors' module. EUDAMED is the sole authentic source for actor data of manufacturers, authorised representat…

1 source-linked fact

Checked 2026-08-25

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D09

Dossier requirements

Verified

Free Sale Certificate: required supporting documents: An application for a Belgian Free Sale Certificate must be supported by the manufacturer's EU declaration(s) of conformity and ISO 9000 / EN ISO 13485 certificates; for devices still under…

1 source-linked fact

Checked 2026-08-25

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D10

Official forms & portals

Verified

Clinical investigation: national application forms and templates: Initial clinical investigation applications under the MDR use the national form EUMDRFORM v1 (with Annexes A/B/C and a prescribed folder structure) plus a GSPR/list of standards template; a…
Official form or portal surface: The national submission surface is the FAMHP web portal (webmedseip, vas.ehealth.fgov.be): registration of activities (distributor, manufacturer, authorised representative, etc.), electroni…

3 source-linked facts

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

EU declaration of conformity: translation requirement: The EU declaration of conformity must be translated into one of the three national languages or into English.
Implant card language: patient's choice: The implant card and the information for the patient are provided in one of the three national languages or in English, at the choice of the patient or their representative.

3 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

Manufacturer quality management system (Art. 10(9)): Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effe…

1 source-linked fact

Checked 2026-08-29

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D13

Standards, testing & ancillary approvals

Unresolved

MDR electrical safety in place of the Low Voltage Directive: Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive: EMC
Arrêté royal du 25 mars 2016 radio equipment conformity: Wireless / radio

7 maintained overlays

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D14

Fees

Verified

Annual fee per device-sector entity (manufacturer, importer, distributor, AR): EUR 424.54
Free-sale certificate: EUR 297.85

2 maintained fee lines · 2 related facts

Checked 2026-08-25

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D15

Review clocks

Unresolved

Class I · Self-declaration (no notified body): 0 days

1 maintained pathway · 1 related fact

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Certificate validity and renewal (Art. 56(2)): EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be…

1 source-linked fact

Checked 2026-08-29

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Lifecycle & post-market

D17

Change control

Verified

Clinical investigation: substantial modifications require opinion/approval: Modifications likely to have a substantial impact on the safety, health or rights of participants may not be implemented without a positive (possibly conditional) opinion from the full agre…

1 source-linked fact

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

Central Traceability Register for implants (RCT): Belgium operates a Central Traceability Register under the Royal Decree of 27 September 2020: notification of the insertion or removal of implants listed in the decree's annex is compulsory…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical investigation: FAMHP validation and single consolidated report: FAMHP is responsible for validation of clinical investigation authorisation applications evaluated at national level and under the coordinated procedure; it consolidates its own assessment…
Clinical investigation dossier: language rules: Application dossiers and post market clinical follow up (PMCF) notifications may be submitted in one of the three national languages or in English; documents addressed to participants must…

3 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Exceptional use: derogation for non-CE-marked devices: Under Article 59 MDR / Article 54 IVDR the FAMHP can authorise the placing on the market / putting into service on Belgian territory of a non CE marked device where duly justified and in th…
Reprocessing of single-use devices: national regime: Under the Law of 22 December 2020 (implementing MDR Art. 17(3) and Implementing Regulation 2020/1207) health institutions may reprocess single use devices for further use; at the institutio…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

PMS/vigilance reports: national language rule: Reports under Articles 86 to 89 of Regulation (EU) 2017/745 (periodic safety update report, post market surveillance report, trend reporting) submitted to the Belgian authority are drafted…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Hospitals: internal materiovigilance contact point: Hospitals must create an internal materiovigilance contact point, notify its details to FAMHP, and FAMHP publishes the list of materiovigilance contact points on its website. The obligation…
National incident-reporting forms and channel: FAMHP operates national notification forms: users outside care settings and care settings (hospitals, rest homes) complete the national notification form (French PDF), routing principally v…

3 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Field safety notices: three-language rule and FAMHP weekly list: Field safety notices must be drafted in the three national languages under Article 65 of the Law of 22 December 2020 on medical devices (Article 64 of the Law of 15 June 2022 for IVDs); whe…
Suspension of a non-compliant economic operator's activities: The federal minister or their delegate may suspend the activities of an economic operator that does not comply with its obligations (including Article 31(5) of Regulation 2017/745) until th…

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Misleading claims prohibition (Art. 7): In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other…

1 source-linked fact

Checked 2026-08-29

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D25

Submission communications & appeal

Verified

Appeal against refusal of a clinical investigation authorisation: A sponsor may lodge a gracious appeal (recours gracieux) with the minister or their delegate against refusal of a clinical investigation authorisation, within thirty days of publication of…

1 source-linked fact

Checked 2026-08-25

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