EU-MDR & MR Clinical Trials in France

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Submissions in France 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 France — including studies using non-CE-marked pulse sequences and/or non-CE-marked RF coils.

Authorities to Submit To

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

• ANSM — Agence nationale de sécurité du médicament et des produits de santé (Competent Authority).
• CPP — Comités de protection des personnes via the national SI RIPH 2G portal (Ethics). See also Ministry resources for CPP/RIPH guidance here.

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:
  • ANSM submission for device investigations (catégorie 1) — see ANSM guidance.
  • CPP ethics submission via SI RIPH 2G (national portal).
• When the EUDAMED CI/PS module is required in France, submit in EUDAMED (see ANSM EUDAMED FAQ for module status).
• 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 France.
• EU Authorised Representative (if sponsor is outside the EU).
• Data protection: GDPR compliance statement and (where applicable) DPIA.
• Participant-facing documents should be provided in French.

5. Ethics Committee Package (CPP)

• PIS & ICF (French language per CPP guidance), privacy wording aligned to GDPR; name files per Ministry CPP document-naming guide (see resources), and submit via SI RIPH 2G.
• Recruitment materials (flyers/posters).
• Investigator CVs & GCP certificates, site suitability, institutional permissions.

Submission Pathway

• Competent Authority (ANSM): submit the MDR clinical investigation dossier according to ANSM requirements (catégorie 1 device investigations); when mandated, use the EUDAMED CI/PS module (see ANSM EUDAMED FAQ for module availability/status).
• Ethics (CPP): submit your CPP dossier via the national SI RIPH 2G portal; follow CPP/Ministry guidance on document structure and naming.

Note: ANSM authorisation and CPP favourable opinion are both required prior to first participant; processes may run in parallel. ANSM publishes detailed dossier content lists for device investigations.

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; see ANSM FAQ on modules).
• France-specific: ANSM device investigation authorisation page; SI RIPH 2G portal; CPP/Ministry resources; ANSM dossier checklist (Annexe 1).
• 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).