🇳🇱 Submissions in the Netherlands 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 the Netherlands — including studies using non-CE-marked pulse sequences and/or non-CE-marked RF coils.
Authorities to Submit To
In the Netherlands, “Requests for authorisation of a clinical investigation” must be made to both:
- CCMO — Central Committee on Research Involving Human Subjects (Competent Authority for clinical investigations with medical devices; manages validation/registration and national guidance).
- Accredited Medical Research Ethics Committees (MRECs) / CCMO acting as reviewing committee (Ethics).
Both a positive ethics decision (MREC/CCMO) and completion of CCMO validation/authorisation steps 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 via the CCMO Research Portal (replaces ToetsingOnline). See CCMO’s Primary submission page and “Standard research file”.
- When the EUDAMED CI/PS module is required in NL, submit in EUDAMED (CCMO provides bridging instructions until full availability).
- 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 the Netherlands.
- EU Authorised Representative (if sponsor is outside the EU).
- Data protection: GDPR compliance statement and (where applicable) DPIA.
5. Ethics Committee Package (MREC/CCMO)
- PIS & ICF (languages per the responsible accredited MREC / CCMO), privacy wording aligned to GDPR; submit via the CCMO Research Portal.
- Recruitment materials (flyers/posters).
- Investigator CVs & GCP certificates, site suitability, institutional permissions.
Submission Pathway
- Competent Authority (CCMO): submit the MDR clinical investigation dossier via the Research Portal. For conformity purposes (MDR Art. 62 / 74.2), CCMO first performs a validation; after a positive validation, the file is forwarded to an accredited MREC or CCMO for review (see Primary submission).
- Ethics (Accredited MRECs / CCMO): file the ethics dossier through the Research Portal to the competent accredited MREC (or CCMO, where applicable).
Note: In NL, CCMO is the competent authority for registrations/notifications relating to device clinical investigations and manages the national Research Portal. Ethics review is performed by accredited MRECs or CCMO as per study type/risk; timelines are coordinated but independent.
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).
- CCMO — Primary submission & validation flow; Research Portal; Accredited MRECs.
- 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).