Overview for MR Trials in the EU using Non-CE marked RF Coils and/or Pulse Sequences

In one minute: what you need to know

• MDR applies across the EU. If your sequence or RF coil is not CE-marked and you use it on humans, you are in investigational device territory and must follow MDR clinical investigation rules (Annex XV) and ISO 14155.
• Submissions are dual-track in every country: a Competent Authority (CA) review and an Ethics Committee (EC) opinion are both required before first use in humans.
• What varies by country: the portal you submit to, the EC setup, language requirements, insurance minimums, and timelines. (See country pages from the map for specifics.)
• Safety first, then study: preclinical evidence (IEC 60601 series, 60601-2-33, NEMA MS-8, 62366-1 usability, 62304 software if applicable) + risk management (ISO 14971) must be in place and summarized in the IB/CIP.

How we got here — a short history for MR researchers

Before MDR, MR research across Europe often ran under a patchwork of national practices rooted in the old MDD/AIMDD. Many sites treated experimental pulse sequences as “research software,” and local ethics approvals sometimes sufficed. With the EU Medical Devices Regulation (MDR 2017/745) fully applicable from 26 May 2021, the lines were clarified: software that drives or provides information for diagnosis is a medical device (typically class IIa/IIb under Rule 11), and accessories like RF coils are regulated as devices in their own right. Clinical investigations now follow a single EU framework (Annex XV + ISO 14155), while the practical submission routes remain national until EUDAMED is fully in force. The upside: clearer expectations. The trade-off: more structure and documentation than many legacy “research mode” workflows had.

Does my MR setup count as a medical device under MDR?

• Non-CE pulse marked sequences used to generate diagnostic information for clinical decision-making are medical device software. Most end up class IIa/IIb depending on intended purpose and risk.
• Non-CE marked RF coils are accessories/active devices; they are regulated devices with their own safety/performance evidence needs.
• Mix of CE and non-CE marked parts: using a CE-marked scanner with a non-CE sequence or coil still triggers MDR clinical investigation requirements for the non-CE component(s).
• Custom-made vs. investigational: most MR research tools are investigational devices (Annex XV). The “custom-made” route is rarely appropriate for generalized research use.

The dossier you’ll need (applies in every EU country)

Wherever you apply in the EU, your package has the same backbone. Expect to assemble:

• Clinical Investigation Plan (CIP) — Annex XV structure: objectives, endpoints, design, monitoring, statistics, reporting, vigilance.
• Investigator’s Brochure (IB) — device description, preclinical evidence, risk/benefit, MR-specific hazards and mitigations.
• Risk Management File (ISO 14971) — hazard analysis covering RF heating/SAR, gradient-induced currents/nerve stimulation, projectile risks, EMC, usability, software failures.
• Preclinical test evidence — typically IEC 60601-1 (electrical safety) and 60601-1-2 (EMC) as applicable; MR-specific 60601-2-33; NEMA MS-8 or equivalent SAR/heating characterization; IEC 62366-1 usability; IEC 62304 software lifecycle (for sequences or control software).
• GSPR mapping (Annex I) — a traceable checklist showing how each requirement is met or, if under investigation, how risks are controlled.
• Labeling/IFU drafts — with “for investigational use only” and all MR safety conditions and contraindications.
• Ethics materials — PIS/ICF (local language), recruitment materials, investigator CVs, GCP training, site suitability.
• Insurance — proof of subject injury coverage meeting national rules; limits and wording vary by country.
• Data protection — GDPR-compliant plan: lawful basis, consent language, minimization, pseudonymization, transfers, retention.

What differs by country (and where your time goes)

• Submission portal & forms: national CA/EC portals (e.g., BfArM/DMIDS in DE, ANSM/CPP in FR, AEMPS/CEIm in ES, CCMO/METC in NL, etc.).
• Language: EC documents usually in the local language; technical dossiers may be accepted in English, but check local rules.
• Insurance minima & contract wording: legally set in some countries (Spain, Italy, etc.).
• Timelines & fees: review clocks and fees vary; most run CA and EC reviews in parallel.

Fast path for MR teams — do this in order

1. Define the intended purpose (what the sequence/coil does and who it’s for). This drives classification, risk controls, and endpoints.
2. Lock the design and risk controls (ISO 14971) and complete the MR-specific preclinical safety set (SAR/heating, gradient safety, EMC, compatibility with scanner).
3. Draft IB and CIP (Annex XV + ISO 14155). Keep endpoints lean, monitoring pragmatic, and reporting clear.
4. Prepare GSPR mapping and gather objective evidence (test reports, analyses).
5. Finalize PIS/ICF (local language), data protection plan (GDPR), and subject insurance.
6. Select sites and get investigator CVs, GCP, and site suitability letters.
7. Submit in the target country to both CA and EC via the national portal. Track questions and plan swift, factual replies.
8. During the study: monitor per plan; report SAEs/SADEs and device deficiencies per MDR; keep deviations under control.

Shortcuts that save you weeks

• Re-use a country-agnostic core dossier (IB, CIP, risk file, GSPR table), then localize only what you must (PIS/ICF, insurance, admin forms).
• Keep an MR-focused safety annex (SAR limits/label, B₁⁺-rms, dB₀/dt, screening and emergency procedures) that ports easily to each site.
• Write your GSPR table once and link to reports by stable filenames; most countries accept the same table.

Ready to dive into a specific Regulations?

Below you will find an interactive EU map. Simply hover and click on your country of interest, and you will be directed to a dedicated page explaining how the EU MDR requirements for MR clinical investigations apply there. This way, you can quickly access the national submission pathway and documents relevant for your research.

Important: If you already have an MR scanner with a “research mode,” remember that research mode ≠ MDR compliance. As soon as the non-CE sequence or coil is used on human subjects, treat it as an investigational device and follow the Annex XV/ISO 14155 path.