EU-MDR & MR Clinical Trials Italy

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

Authorities to Submit To

In Italy, “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 and Ethics:
    • For non-CE-marked devices (or CE-marked used outside intended purpose): authorisation request to the Ministry per national instructions (link).
    • For CE-marked devices within intended use (PMCF): notify per Ministry online services (PMCF start communication), or follow national instructions (PMCF guidance).
  • When the EUDAMED CI/PS module is required in Italy, submit in EUDAMED.
  • 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 Italy.
  • 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 Italian (and local site language versions where relevant).

5. Ethics Committee Package (CET/CEN)

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

Submission Pathway

  • Competent Authority (Ministero della Salute): for non-CE-marked devices or CE-marked used outside intended purpose, obtain Ministry authorisation (see guidance). For CE-marked PMCF studies within intended use, file the PMCF start communication and, when applicable, the 30-day PMCF notification via Ministry online services (start / PMCF guidance). When mandated, use the EUDAMED CI/PS module.
  • Ethics (CET/CEN): obtain a favourable opinion valid nationally from the competent ethics committee (territorial or national), per AIFA/CCNCE procedures.

Note: In Italy, Ministry validation/authorisation and Ethics review can run in parallel. Coordinate timelines and notify both bodies of any substantial modifications.

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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