EU-MDR & MR Clinical Trials Belgium

🇧🇪Submissions in Belgium under MDR

This article provides a structured overview for MR-scientists on how to prepare and where to submit the required documents for a medical-device clinical investigation in Belgium — including studies using non-CE-marked pulse sequences and/or non-CE-marked RF coils.

Authorities to Submit To

In Belgium, “Requests for authorisation of a clinical investigation” must be made to both:

• Federal Agency for Medicines and Health Products (FAMHP/AFMPS) — Medical Devices (Competent Authority).
• Recognised Ethics Committees (ECs) (Ethics).

Both approvals are required before starting the investigation.

Key Documents Required

The required documents can be divided in 5 groups:

1. Application Forms

• MDR Clinical Investigation application to the Competent Authority and Ethics:
  • Follow FAMHP’s national guidance: Guideline on Submission Processes of Clinical Investigations according to MDR (v11.0, 2025).
  • Use the EU MDCG 2021-8 application template where applicable.
• While the national route remains in use, submit electronically via the CESP channel as instructed by FAMHP; an EUDAMED CIV-ID is assigned/confirmed by FAMHP (see v11.0 guidance). When mandated in Belgium, use the EUDAMED CI/PS module.
• Cover letter summarising device, investigational components (non-CE sequence/coil), sites, participants, timelines.

2. Clinical Investigation Documentation

• Clinical Investigation Plan (CIP) — MDR Annex XV format.
• Investigator’s Brochure (IB) — device/system description (scanner + software + coil + sequences), risk profile, MR-specific precautions.
• Risk Management File (ISO 14971), Monitoring Plan, CRFs, AE/SAE reporting procedures.

3. Safety and Performance Evidence (MR-specific)

• IEC 60601-2-33 rationale for MR environments (SAR/local-SAR limits; simulations and phantom measurements).
• RF coil dossier (manufacturer ISO 13485 certificate, coil-file, FDTD/Sim4Life B1+/SAR simulations, phantom thermometry, safety report).
• Sequence safety (vendor statements that scanner safety controls remain active; watchdogs/limits; access controls to prevent accidental use).
• Best practices (e.g., ISMRM recommendations for experimental RF hardware) referenced in IB/annexes.

4. Regulatory and Legal Documents

• Insurance certificate covering participants in Belgium.
• EU Authorised Representative (if sponsor is outside the EU).
• Data protection: GDPR compliance statement and (where applicable) DPIA.
• Consider Belgium’s recognised EC templates (e.g., model ICF coordinated by BAREC) where applicable.

5. Ethics Committee Package (Recognised ECs)

• PIS & ICF (languages per the responsible recognised EC), privacy wording aligned to GDPR; use local templates where available.
• Recruitment materials (flyers/posters).
• Investigator CVs & GCP certificates, site suitability, institutional permissions.

Submission Pathway

• Competent Authority (FAMHP): Belgium applies full assessment of all MDR clinical investigation applications regardless of device class and uses distinct pathways (e.g., consolidated FAMHP+EC opinion; separate FAMHP and EC opinions) depending on device status and study type; see v11.0 guidance. Until EUDAMED CI is fully mandatory, submit via CESP; an EUDAMED CIV-ID is issued/confirmed by FAMHP. When mandated, use the EUDAMED CI/PS module.
• Ethics (Recognised ECs): submit per the EC’s procedures. Depending on the pathway, you may file in parallel or seek a consolidated opinion (see FAMHP v11.0).

Note: Coordinate timelines for EC and FAMHP. Belgium’s v11.0 guidance includes decision trees to select the correct pathway (e.g., PMCF with additional burdensome procedures; CE-marked in-scope “EC only”; custom-made/in-house separate opinions).

MR-specific notes for studies using non-CE sequences and/or non-CE RF coils

• Define the investigational device system clearly (CE-marked scanner/software + investigational coil/sequence package) and state risk class in CIP/IB.
• Evidence package: B1+ maps, SAR/local-SAR analyses, worst-case duty-cycle temperature estimates, phantom thermometry at hotspot locations (e.g., eye and cortical regions).
• Operational controls: show that scanner SAR/gradient watchdogs remain active with investigational components; document password-protected access and prevention of accidental use.
• Standards mapping: cross-reference IB/CIP evidence to IEC 60601-2-33 and your applicable standards list; cite ISMRM RF-hardware safety recommendations.

Relevant References

• EU MDR 2017/745 (esp. Articles 62–82, Annex XV).
• EUDAMED CI/PS submission (when applicable).
• MDCG guidance and MDCG 2021-8 application template.
• IEC Webstore — download/purchase IEC standards (e.g., IEC 60601-2-33 and the IEC 60601 series).
• ISO Standards Catalogue — download/purchase ISO standards (e.g., ISO 14971 and the ISO 10993 series).