GSPR of a non CE-marked RF-coil

GSPR documents required for a CA-application when using a non-CE-marked RF-coil

This page lists the technical documentation expected by Competent Authorities in the EU and Switzerland when your MRI clinical investigation uses an external, non-CE-marked RF-coil. It aligns with the MDR’s Annex I GSPR, EU guidance (MDCG 2024-5), and Swiss ClinO-MD.

Who you submit to (context)

  • Switzerland (CH): Ethics via BASEC + Swissmedic (ClinO-MD). The submission cites Annex I GSPR conformity for all device parts used in humans.
  • EU/EEA: National Competent Authority + Ethics per MDR & national processes; IB content per MDCG 2024-5.

Clinical investigation conduct should follow ISO 14155:2020.

Core GSPR pack (for the whole investigational setup)

Provide these items for the full setup (scanner, sequences, accessories, and the external RF-coil):

  1. Device description (intended purpose, configuration, variants; identify investigational vs CE-marked parts; UDI where applicable).
  2. Risk management file per ISO 14971:
    hazard analysis (RF heating, PNS, acoustic, burns, misuse), risk controls, verification, residual-risk/benefit-risk.
  3. GSPR checklist (Annex I matrix): each applicable requirement → evidence (test report, analysis, IFU control) and status (met/under investigation).
  4. Bench & pre-clinical evidence (where applicable):
  5. Labelling & IFU drafts (warnings/precautions, setup limits). MRI safety symbols per
    ASTM F2503-20.
  6. Investigator’s Brochure (IB) content aligned to MDCG 2024-5;
    study conduct per ISO 14155.

What the external RF-coil builder must provide

These coil-specific files/supporting documents are typically required so the sponsor can demonstrate Annex I GSPR conformity for the coil:

  1. Coil identification & configuration dossier:
    model/version, serials, channels, connectors, tuning/matching, maximum input power/voltage/current, duty-cycle limits, applicable scanner platforms/software.
  2. Engineering drawings & schematics:
    RF circuit diagrams, housing drawings, wiring, baluns/chokes, detuning/active-detune, cable routing, and connector pin-outs.
  3. Risk Management File (ISO 14971):
    hazard analysis specific to the coil (contact burns, coupling/hot-spots, cable traps, detune failure, condensers, ESD), risk controls, and verification of effectiveness.
  4. Electrical & basic safety evidence:
    tests against IEC 60601-1 (as applicable to accessories),
    leakage currents with representative scanner interfaces, insulation and creepage/clearance data.
  5. EMC/EMI statements:
    rationale or tests per IEC 60601-1-2 regarding emissions/immunity for the assembled system; cable/connector mitigation.
  6. MRI-particular evidence:
    • Verification that hardware and control logic respect IEC 60601-2-33 limits when used as intended.
    • SAR/heating evidence:
      EM simulations (loading scenarios, 10 g peak SAR, B1+ maps) and phantom heating tests;
      reference/trace to methods compatible with NEMA MS-8 where applicable.
    • Detune/fail-safe testing (active/passive detune, fuse behaviour) including worst-case duty cycle.
  7. Materials & biocompatibility (ISO 10993) for all patient-contacting surfaces:
    contact type/duration, cytotoxicity, sensitisation, irritation (and any justification for limited testing if surfaces are fully isolated).
  8. Cleaning & disinfection instructions with validation (agent compatibility, cycles, no residue/thermal damage).
  9. Label set & IFU (drafts):
    MR safety status per ASTM F2503-20 (MR Safe/Conditional/Unsafe), operating limits (power, duty, landmarks), contraindications/precautions, installation/positioning steps, and maintenance checks.
  10. Traceability & QMS statements:
    manufacturing lot/serial traceability; if available, ISO 13485 certificate or equivalent quality controls;
    change-control contact for updates during the trial.
  11. Compatibility declaration with target scanners:
    tested platforms/software (e.g., model & SW release), any required “coil file/registration” parameters for the scanner safety model, and known limitations.
  12. Transport/storage conditions & visual inspection/functional test checklist (incoming and before each use).

How to ideally structure the submission bundle 

/GSPR_Coil_Pack/
  01_Device_Description/
  02_GSPR_Checklist_AnnexI_Matrix.xlsx
  03_Risk_Management_ISO14971/
  04_Test_Reports/
      04a_IEC60601-1/
      04b_IEC60601-1-2_EMC/
      04c_IEC60601-2-33_MR/
      04d_SAR_Sims+Phantom_(NEMA_MS8_ref)/
      04e_Biocomp_ISO10993/
      04f_Usability_62366-1/
  05_Drawings_Schematics/
  06_Label_IFU_(ASTM_F2503-20)/
  07_Cleaning_Disinfection_Validation/
  08_Compatibility_Declarations/
  09_QMS_Traceability/
  10_IB_Extracts_and_CIP_Crossrefs/

References

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