EU-MDR & MR Clinical Trials Spain

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

Authorities to Submit To

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

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 (AEMPS), coordinated with a CEIm ethics submission per the national AEMPS–CEIm memorandum.
  • When the EUDAMED CI/PS module is required in Spain, submit in EUDAMED (AEMPS provides bridging instructions until full EUDAMED availability).
  • Cover letter summarising device, investigational components (non-CE sequence/coil), sites, participants, timelines.

2. Clinical Investigation Documentation

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 Spain.
  • 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 Spanish; local site language versions may also be requested by CEIm.

5. Ethics Committee Package (CEIm)

  • PIS & ICF (Spanish language per CEIm requirements), privacy wording aligned to GDPR.
  • Recruitment materials (flyers/posters).
  • Investigator CVs & GCP certificates, site suitability, institutional permissions.

Submission Pathway

  • Competent Authority (AEMPS): submit the full MDR clinical investigation dossier via the national process for device investigations; AEMPS and CEIm coordinate their evaluations per the national memorandum. When mandated, use the EUDAMED CI/PS module; AEMPS also provides instructions for publications and reporting until EUDAMED is fully available.
  • Ethics (CEIm): submit to a recognised CEIm in line with national procedures; favourable CEIm opinion is required prior to first participant.

Note: Spain applies MDR (EU) 2017/745 alongside national provisions (e.g., Royal Decree 192/2023). Coordinate timelines; CA and Ethics reviews often run in parallel, with information-sharing mechanisms defined between AEMPS and CEIm.

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

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