🇸🇰 Submissions in Slovakia 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 Slovakia — including studies using non-CE-marked pulse sequences and/or non-CE-marked RF coils.
Authorities to Submit To
In Slovakia, “Requests for authorisation of a clinical investigation” must be made to both:
- State Institute for Drug Control (ŠÚKL) — Medical Devices Section (Competent Authority). See also ŠÚKL’s device clinical-investigation guidance (SK): information hub and application requirements (PDF).
- Ethics Committee for Clinical Trials (Ministry of Health of the Slovak Republic) (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:
- ŠÚKL — device CI requirements (SK): MP_147-2024 (PDF) and the clinical investigation hub.
- When the EUDAMED CI/PS module is required in Slovakia, 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 Slovakia.
- EU Authorised Representative (if sponsor is outside the EU).
- Data protection: GDPR compliance statement and (where applicable) DPIA.
5. Ethics Committee Package (Ministry EC)
- PIS & ICF (languages per the Ministry’s Ethics Committee requirements), privacy wording aligned to GDPR.
- Recruitment materials (flyers/posters).
- Investigator CVs & GCP certificates, site suitability, institutional permissions.
Submission Pathway
- Competent Authority (ŠÚKL — Medical Devices Section): submit the full MDR clinical investigation dossier via the national process per ŠÚKL guidance (see device CI requirements: PDF); when mandated, use the EUDAMED CI/PS module.
- Ethics (Ministry Ethics Committee): submit the ethics dossier per the committee’s forms and instructions.
Note: In practice, CA and Ethics reviews may 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
- 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).