🇨🇭Submissions in Switzerland under ClinO-MD
This article provides a structured overview for Swiss MR-scientists on how to prepare and where to submit the required documents for medical device clinical trials in Switzerland.
The focus is on studies involving non-CE-marked pulse sequences or
non-CE-marked RF coils.
Authorities to Submit To
In Switzerland, clinical investigations of medical devices must be approved by both:
- Swissmedic – the national Competent Authority (CA) for medical devices.
- Responsible Cantonal Ethics Committee (via BASEC) – the ethics review board for the PI’s site.
Both approvals are required before starting the investigation. Applications are submitted in parallel through the BASEC portal and the Swissmedic portal.
Key Documents Required
The required documents can be divided into 5 groups:
1. Application Forms
- Swissmedic application form (available via Swissmedic website).
- Cover letter.
2. Clinical Investigation Documentation
- Clinical Investigation Plan (CIP) – ClinO-MD Annex format.
- Investigator’s Brochure (IB).
- Risk Management File (ISO 14971).
- Technical Documentation relevant for GSPR compliance (Annex I MDR as adopted in ClinO-MD).
- Labeling and IFU drafts (“for investigational use only”).
- Device description and manufacturing information.
3. Safety and Performance Evidence
- Preclinical test reports (IEC 60601 series, IEC 62366-1, IEC 62304, etc.).
- Biocompatibility data (ISO 10993).
- MR-specific safety data (e.g., NEMA MS 8, SAR/heating tests, IEC 60601-2-33).
4. Regulatory and Legal Documents
- Insurance certificate compliant with Swiss HRA/ClinO-MD requirements (must cover subject injury).
- EU/CH legal representative (if sponsor is outside Switzerland or EU).
- GDPR/FADP compliance statement (data protection under EU GDPR and Swiss FADP).
5. Ethics Committee Package
- Patient Information Sheet (PIS) & Informed Consent Form (ICF) in German, French, or Italian (depending on site).
- Recruitment materials (flyers, posters).
- Investigator CVs and GCP certificates.
- Site suitability documentation.
Submission Pathway
- Swissmedic:
- Cantonal Ethics Committee (EC): Submission through the BASEC portal.
Note: Swissmedic and EC reviews run in parallel; both approvals are required before initiating the investigation.
Relevant References
- Human Research Act (HRA) – Federal Act on Research involving Human Beings.
- ClinO-MD (Ordinance on Clinical Trials with Medical Devices) – in force since 26 May 2021.
- EU MDR 2017/745 (as reference model – Swiss ClinO-MD harmonizes with MDR).
- ISO 14155:2020 – Clinical investigation of medical devices for human subjects.
- BASEC portal – Ethics and Swissmedic submission system.