EU-MDR & MR Clinical Trials Luxembourg

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

Authorities to Submit To

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

• Ministry of Health and Social Security — Health Directorate (Direction de la Santé), Division de la Pharmacie et des Médicaments (DPM) (Competent Authority).
• National Research Ethics Committee (CNER) (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:
  • Use the MDCG 2021-8 application template and submit per national instructions (see CA guidance above).
• When the EUDAMED CI/PS module is required in Luxembourg, submit in EUDAMED.
• 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 Luxembourg.
• EU Authorised Representative (if sponsor is outside the EU).
• Data protection: GDPR compliance statement and (where applicable) DPIA.
• Participant-facing documents should include French and German versions (Luxembourg language expectations).

5. Ethics Committee Package (CNER)

• PIS & ICF (languages per CNER guidance; include French & German versions), privacy wording aligned to GDPR.
• Recruitment materials (flyers/posters).
• Investigator CVs & GCP certificates, site suitability, institutional permissions.

Submission Pathway

• Competent Authority (Ministry of Health & Social Security — Health Directorate / DPM): file the MDR clinical investigation dossier using the MDCG 2021-8 form; when mandated, use the EUDAMED CI/PS module.
• Ethics (CNER): submit the ethics dossier per CNER procedures; investigators present their study at a monthly CNER meeting; opinions are typically issued within 10 working days after the meeting.

Note: In Luxembourg, ministerial authorisation follows the scientific opinion of the Health Directorate and a positive ethics opinion from CNER; CA and Ethics timelines may proceed in parallel. Provide French/German participant documents and proof of insurance as specified in national guidance.

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).