How to Apply for a Swissmedic Approval for your MR-research

Desperate Swiss MR-scientist

🇨🇭 How to Apply for a Swissmedic Approval of your MR-Research in Switzerland

This guide explains the process to obtain authorization from Swissmedic for conducting research involving MR systems (such as high-field MRI) classified as medical devices (MD) in Switzerland.

A similar framework also applies within the EU under the Medical Device Regulation (MDR).

🇪🇺🇨🇭 Before you start in EU & CH

If you are a typical MR-scientist, or person who would like to do an MR-study with non-CE-marked components (like pulse sequences, and/or RF-hardware) than first identify your competent authorities, and try to get statements from them on which procedure you should follow with your project. This can save you a lot of annoyance, stress and time. Even when the EU-MDR and ClinMD-O seem to be unambiguous, there are differences in how the legislation is interpreted amongst countries, and even within Switzerland.

🇨🇭 Legal and Regulatory Framework

🇨🇭 Swissmedic Official Resources

You can find all official Swissmedic guidance for clinical investigations with medical devices on their dedicated page: Clinical Investigations of Medical Devices.

🇨🇭 eDoc Structure & Guidance

Swissmedic mandates applications be submitted in a structured eDoc format (electronic dossier), which ensures clear organization of all documentation (akin to CTD modules in pharma).
The official guidance is here:

👉 Guidance Document on eDoc (PDF, German)

🇨🇭When to Use the BW610_10_021e_FO Form?

If you plan to use non-CE-marked pulse sequences and/or non-CE-marked RF coils or other scanner hardware in your MR study, you must complete the specific Swissmedic application form:

👉 BW610_10_021e_FO – Application for Clinical Investigation with Medical Devices

This ensures compliance with Swiss law when investigating investigational devices or device components that have not yet been CE-marked for safety and performance.

🇨🇭 Typical Entries in the eDoc Application

Key parts of your application will include:

  1. Cover letter and summary – overview of the investigation, purpose, device, sponsor details.
  2. Administrative documents – sponsor declaration, investigator agreements, insurance policies.
  3. Device description – technical files, CE certificates (if applicable), risk classification.
  4. Clinical investigation plan – objectives, methodology, inclusion/exclusion criteria.
  5. Risk assessment – hazards, mitigation measures, justification of safety.
  6. Investigator’s Brochure (IB) – device-specific info for clinical investigators.
  7. Data management & statistics – analysis plans, data integrity safeguards.
  8. Informed consent forms (ICF) and patient information sheets.

More details you will find below.

🇨🇭 Submitting Your Application

Your eDoc is submitted simultaneously to Swissmedic and the responsible Cantonal Ethics Committee. Swissmedic provides a special electronic submission portal where applicants submit the eDoc formatted application for a medical device study.

Example: eDoc Folder Structure for a Swissmedic Medical Device Trial

Below is an example of a typical Swissmedic eDoc folder structure for a clinical investigation involving non-CE-marked pulse sequences and/or MR hardware (such as RF coils).

This rigorous directory layout ensures all required documents — from approval application forms, cover letters, CE marking statements (or lack thereof), CRFs, ICFs, ISO 14155 compliance files, MRI-specific checklists, ionising radiation safety information, to periodic reports — are consistently organized under predefined numbered folders.

Each folder name and position is critical, closely following Swissmedic’s official eDoc Guidance Document (PDF). This structure facilitates the review by both Swissmedic and the Ethics Committees. 

The following entries in bold need to have content:

🇨🇭 Swissmedic eDoc Folder Structure (for MR trial with non-CE-marked components)

This shows your eDoc directory tree, now annotated with placeholders explaining typical content and are marked in bold. Blue are indicated the file names which were uploaded for the SIGNATURES2023 trial:

  • OS000_00_008dfe_VZ_KlinV
    • 00.00_Swissmedic_Forms
      • 00.1.0_Approval_application_form
        • BW610_10_021e_FO_Authorisation_clinical_investigation_MD.pdf
      • 00.2.0_Approved_trial_forms
        • {empty}
      • 00.3.0_Swiss_SAE-forms
        • SAE_Form_SIGNATURES2023_Swissmedic_v2_clean.pdf
      • 00.4.0_Simplified_review_forms
        • {empty}: Note: inquire with your ethics commission whether your MR-study fulfills the criteria for a simplified procedure, can save you a lot of unnecessary work under circumstances!)
    • 01.00_Cover_letter
      • e.g. Coverletter-Swissmedic–SIGNATURES2023-Amendment1-07-2025-Signed.pdf
    • 02.00_Ethics_committees_decisions
      • e.g. b2023-d0060-slotboomj-s3-verfugung-amend-anderungen-entscheid-von-swissmedic-bew.pdf
    • 03.00_Foreign_Competent_Authority_decisions
      • Add decisions of foreign CA’s if applicable.
    • 04.00_CIP_or_CPSP
      • See what document you need in the section below. In the SIGNATURES2023 trial the required document was a CIP. For a detailed approved CIP for the ethics commission in Bern, please visit this blog post. 
    • 05.00_CRF
      • CRF stands for case report form. These forms contain (clinical) data that is collected of patients/healthy controls in the trial. These forms are binding, in the sense that once approved by the ethics committee and CA they must be amended if changes are necessary for the study. For example:
      • CRF_HGCS_SIGNATURES2023_V4_06092024-clean.pdf
      • CRF-MCI-AD-SIGNATURES2023-V4-06092024-clean.pdf
      • CRF_DM_SIGNATURES2023_V4_06092024-clean.pdf
      • CRF_MRSI_HC_Patients_SIGNATURES2023_V4_06092024-clean.pdf  
    • 06.00_PI_ICF
      • 🔎 What does PI_ICF mean?When you start preparing your first submission, these abbreviations can be confusing.
        PI stands for Patient Information — a document that explains in plain language
        what the study is about, the procedures, possible risks, benefits, and the rights of participants.
        ICF stands for Informed Consent Form — the actual legal document that participants (or their legal representatives) sign to confirm that they understand the study and voluntarily agree to take part. These two documents together ensure ethical transparency and compliance with Swiss HRA/ClinO-MD and EU MDR requirements.
    • In the SIGNATURES2023 trial this contained multiple combined PI_ICF documents:
      • Flyer_Gesunde_Probanden_SIGNATURES2023_v4_clean.pdf
      • Studieninformation-DMT2-SIGNATURES2023-v4-clean.pdf
      • Studieninformation-Gesunde-Kontrollen-SIGNATURES2023-version-4-clean.pdf
      • Studieninformation-HGCS-SIGNATURES2023-v4-clean.pdf
      • Studieninformation-MCI-AD-SIGNATURES2023-v4-clean.pdf
    • 07.00 Compliance EN ISO14155_ISO20916
      • 📑 What does “Compliance EN ISO14155_ISO20916” mean? This section of your eDoc structure holds documentation showing that your study
        and devices conform to internationally recognized standards for clinical investigations:

        • ISO 14155: This standard specifies requirements for the design, conduct, recording, and reporting of clinical investigations of medical devices involving human subjects. It ensures that your MR study is performed ethically and scientifically, with rigorous risk management, monitoring, and data quality — essentially the Good Clinical Practice (GCP) standard for medical device trials.
        • ISO 20916: This standard applies exclusively to in vitro diagnostic (IVD) medical devices, describing requirements for clinical performance studies where samples (blood, tissue, etc.) are tested outside the body.
          ✅ For in vivo MR research trials, ISO 20916 is not applicable, since it does not govern human imaging studies.

        ✅ Typically, in this folder you include compliance or conformance statements from the MR scanner manufacturer and from your non-CE-marked dual-tuned head coil supplier, demonstrating adherence to ISO 14155. This helps show your commitment to internationally accepted clinical quality standards, making the Swissmedic and ethics committee review smoother. You can also include a statement on your pulse sequence to inform that conformance to ISO 14155 is given.

      • Scanner_Manufacturer_Conformity_With_Standards_yyy_xxxxx_Research.pdf
      • RF-coil-manufacturer_ISO_13485_2016_Certificate.pdf
    • 08.00_General_device_information
      • 08.1.1_IB
        • Investigator’s Brochure (IB)
        • 📘 What is an Investigator’s Brochure (IB)? The IB is a comprehensive document prepared to provide investigators, ethics committees, and regulatory authorities with a thorough summary of all relevant clinical and non-clinical data on the investigational medical device. It enables investigators to understand the device’s design, prior experience, risk profile, and safe use in the clinical study. Both Swissmedic (under ClinO-MD and the Swiss HRA) and EU Competent Authorities (under MDR 2017/745) require an IB for device trials. There is no significant difference between Swiss and EU expectations — the IB ensures your study is ethically justified, scientifically sound, and that investigators can safely inform participants. It serves as the equivalent of an “Investigator’s Brochure” in pharmaceutical trials under ICH GCP, but tailored to medical devices.

          🔎 Typical contents of an IB

          • Device description & intended use – explains how the device functions and what indication it targets.
          • Design features & technical specifications – schematics, materials, electromagnetic parameters (like gradient or SAR limits for MRI), etc.
          • Pre-clinical testing & performance data – evidence from bench or animal studies to show safety and performance.
          • Known risks & mitigation measures – identified hazards and how risks are controlled or monitored.
          • Instructions for use (IFU) during the study – how the device will be handled, operated, calibrated, or adjusted.
          • Available clinical data – data from prior clinical investigations or published studies, if applicable.
          • Storage & handling requirements – special conditions for parts or consumables.
          • Emergency procedures & troubleshooting – investigator guidance if problems arise.

          📂 Mapping to eDoc structure

          IB content Typical eDoc folder location
          Device description, intended use, technical details 08.1.1_IB, also cross-referenced by 08.1.2_IFU
          Pre-clinical / bench testing 08.1.1_IB, or as attachments under 08.1.3_additional_device_information
          Known risks & mitigations 08.1.1_IB plus referenced risk analyses often in 08.1.3
          Instructions for use (IFU) 08.1.2_IFU (but key points often summarized in IB)
          Prior clinical data 08.1.1_IB, sometimes also included in 08.1.5_IB_information_on_off-label_use
          Emergency / troubleshooting guidance 08.1.1_IB

          ✅ This structured approach ensures investigators and ethics reviewers can easily find essential information on the investigational device, fully aligned with both Swissmedic ClinO-MD requirements and EU MDR Annex XV.

        • e.g. in the SIGNATURES2023 trial the following IB was uploaded:
          • Investigator Brochure-v6.0-SIGNATURES2023-clean.pdf
        • A more detailed description of how to write a detailed IB you find (here..)
      • 08.1.2_IFU
        • IFU – Instructions for Use (IFU)
        • 📄 What is an IFU exactly?
          The Instructions for Use (IFU) is a formal document provided by the device manufacturer that explains how to correctly and safely use the device under investigation. It is a critical regulatory and ethical requirement for all clinical investigations, as it ensures that investigators and clinical staff are fully informed on proper installation, operation, limitations, and maintenance procedures.In your MR trial, this section typically holds two distinct types of IFUs:

          • IFU for the non-CE-marked RF coil:
            • Provided by the RF coil manufacturer (e.g. for a dual-tuned 1H/31P head coil).
            • Details how to install the coil, position it on the subject, connect it to the MR system, and interpret safety checks (like coil tuning & matching).
            • Outlines any limitations (e.g. maximum B1+, SAR contributions, head geometry constraints etc.) to ensure safe operation.
          • IFU or user documentation for the pulse sequence development environment:
            • Provided by the MR scanner manufacturer (e.g. Siemens IDEA or similar).
            • Explains how users can create, modify, and test pulse sequences on the MR system.
            • Includes safeguards (such as SAR monitoring, gradient checks) and instructions to validate compliance with IEC 60601-2-33 and local safety thresholds.
            • Own IFUs for pulse sequences.
      • 08.1.3_additional_device_information
        • 📂 What goes into into this additional device information section?This section gathers all supplementary documents provided by the MR scanner manufacturer that support the safety, technical conformance, and proper operation of the scanner in the context of your trial. It often includes specific safety statements, SAR and gradient performance documentation, hardware compliance confirmations, and internal manufacturer risk assessments. In your study, this folder also contains the research contract or collaboration agreement with the scanner manufacturer, which can be essential to demonstrate mutual responsibilities, maintenance provisions, and support for operating non-CE-marked RF coils or investigational pulse sequences. The following files were uploaded for the SIGNATURES2023 trial:
        • {scanner_manufacturer}_01_User_Sequenz_Entwicklung_Stellungnahme.pdf
        • {scanner_manufacturer}_02_WIP_Sequenzen_Safety_Stellungnahme.pdf
        • {scanner_manufacturer}_03_Stellungnahme_Research_License_Mode.pdf
        • {scanner_manufacturer}_04_System_Owner_Manuel_Safety_Part.pdf
        • {scanner_manufacturer}_05_{scanner_model}_Operator_Manuals.pdf
        • {scanner_manufacturer}_06_Master_Research_Agreement_{your_institution}.pdf
        • {scanner_manufacturer}_07_Conformity_Standards_{scanner_model}_Research.pdf
        • {scanner_manufacturer}_08_Safety_Statement_3rd_Party_Coils_2023_05_23.pdf
        • {scanner_manufacturer}_09_Terra1Tx+pTx_SystemFlowChart.pdf
        • {scanner_manufacturer}_10_ConformityWithStandards__for_Research.pdf
        • {scanner_manufacturer}_11_1Tx+pTx_IEC60601-1_Excerpt.pdf
      • 08.1.4_CE_marking_information
        • {no documents uploaded in this section} The MR-trial used a non CE-marked RF-coil and non CE-marked pulse sequences. (C2 trial).
      • 08.1.5_IB_information_on_off-label_use
        • {no documents uploaded in this section} The MR-trial used a non CE-marked RF-coil and non CE-marked pulse sequences. (C2 trial).
      • 08.2.0_Applicable_standards_list
        • {rf-coil-manufacturer}_01_ISO_13485_2016_Certificate.pdf
        • {rf-coil-manufacturer}_02_Risk_Management_File_DHF_BRN00002_RMF.pdf
        • {rf-coil-manufacturer}_03_Gen_Safety_Perf_Reqs_BRN00002_GSPR.pdf
        • {rf-coil-manufacturer}_04_Instructions_For_Use_BRN00002.pdf
        • {rf-coil-manufacturer}_05_Safety_Report_BRN00002.pdf
        • {rf-coil-manufacturer}_06_Compliance_Declarations.pdf
        • ThermoFischer-Scientific-Security-Information-alpha-D-glucose.pdf
        • {scanner-manufacturer}_ConformityWithStandards_TerraResearch.pdf
        • {scanner-manufacturer}_Stellungnahme_researchlicensemode.pdf
        • {scanner-manufacturer}_Insel_IPA_27_sitem-insel_projects_signed.pdf
        • {scanner-manufacturer}_1Tx+pTx_IEC60601-1_Excerpt.pdf
        • {scanner-manufacturer}_1Tx+pTx_SystemFlowChart.pdf
        • CambridgeIsotope17025CertScope_V008.pdf (deuterated glucose)
        • CambridgeIsotope17034CertScope_V009.pdf (deuterated glucose)
        • UFAG-AG-Toxicologic-Test-Report-Glukose-21-24696.pdf
      • 08.3.0_Manufacturer_statement
        • {rf-coil-manufacturer}_Compliance_Declarations.pdf
        • {scanner-manufacturer}_ConformityWithStandards_10882763_Research.pdf
      • 08.4.0_Documentation_access_confirmation
        • INSEL_Spital_ManufacturerDocumentationAccesConfirmation_V2.pdf
          • Statement of PI on developed pulse sequences.
    • 09.00_Animal_origin_information
      • {no documents uploaded in this section}
    • 11.00_MRI _checklist
      • {no documents uploaded in this section}
    • 13.00_Contract_with_manufacturer
      • {rf-coil-manufacturer}-vs-Inselspital-Research-Contract.pdf
      • {scanner-manufacturer}_Master_Research_Agreement_Insel_Bern.pdf
    • 12.00_Ionising_radiation_information
      • {no documents uploaded in this section}
    • 14.00_Trial_centres_list
      • Trial_Center_List_V1.pdf
    • 15.00_Other_documents
      • Risk_Analysis_v2_SIGNATURES2023.pdf
      • Risk_Management_Plan_v2_SIGNATURES2023.pdf
      • Risk_Management_Report_v2_SIGNATURES2023.pdf
      • Financial_Support_Application_Project_SIGNATURES2023_SNF-Applicatio.pdf
      • Financial_Support_Application_SISF_Funding.pdf
      • Financial_Support_Application_VCCI_MIP.pdf
      • Financial_Compensation_of_Testpersons_SIGNATURES2023_v2.pdf
      • Previous_Related_Project_SIGNATURES2023_SNF_EPSI_proposal.pdf
      • CV_of_PI.pdf
      • GCP_Course_&_Advanced_GPC_Course_of_PI_Cirtification.pdf’
      • GCP-Basec_Course_of_PI_Certification.pdf
      • QualifikationPruefort_SIGNATURES2023_v2.pdf
      • Project_SIGNATURES2023-Monitoring-Plan-V2.pdf
      • Project_SIGNATURES2023_Staff_list_v2.pdf
    • 16.00_Continued_use_predecessor_model
      • {no documents uploaded in this section}
    • 17.00_Reports_notifications
      • 17.1.0_Summary_safety_report_forms
        • {to be filled during MD-trial}
      • 17.2.0_Interim_reports
        • {to be filled during MD-trial}
      • 17.3.0_Annual_reports
        • {to be filled during MD-trial}
      • 17.4.0_Final_report
        • {to be filled at end of MD-trial}
      • 17.5.0_Halt_premature-termination_completion
        • {contains a document if the MD-trial is terminated prematurely}

🇪🇺🇨🇭 What is the difference between a CIP and a CPSP?

In the context of clinical trials involving medical devices, the documents Clinical Investigation Plan (CIP) and Clinical Performance Study Plan (CPSP) serve as the core protocols that define how the study will be conducted. Although they look similar, they apply to different categories of devices and regulatory pathways.

Aspect CIP CPSP
Full term Clinical Investigation Plan Clinical Performance Study Plan
Applies to Medical devices (including MRI scanners, RF coils, pulse sequences) In vitro diagnostic medical devices (IVDs)
Swissmedic🇨🇭  (Switzerland) Governed by ClinO-MD; submitted for clinical investigations under Swiss HRA and TPA Governed by IvDO (Ordinance on IVDs); requires CPSP for performance studies
CA (EU) 🇪🇺 Governed by MDR (EU) 2017/745; CIP required for device trials Governed by IVDR (EU) 2017/746; CPSP required for performance studies
Main purpose To demonstrate the safety & performance of a medical device (especially if non-CE-marked or new indication) To demonstrate the clinical performance of an IVD test (sensitivity, specificity, etc.)
Typical contents Study objectives, endpoints, risk analysis, patient selection, monitoring, statistical plan Performance objectives, analytical & clinical performance parameters, specimen handling, evaluation criteria

✅ In your MR device research project with non-CE-marked sequences or hardware, you will prepare a CIP. The 04.00_CIP_or_CPSP folder in the eDoc structure is there to accommodate either document type depending on the nature of the device.

 

⚠️🇨🇭 Important pitfalls you should avoid:

  • Do not add any subdirectories inside these eDoc folder structure — even if you think it helps to further organize files. Your upload gets (very treacherous) rejected after 5-10 minutes. This cost me a month of delay in the application process.
    The directory tree must exactly match Swissmedic’s specification, with no extra nesting.
  • Do not delete any of the provided directories, even if you believe they do not apply to your study.
    They must remain present (possibly empty) to pass validation.
  • Include only allowed file types. While it’s common to use PDFs and other approved formats,
    you cannot upload unapproved or exotic file types. Zip archives themselves must strictly follow Swissmedic’s rules. our upload gets (very treacherous) rejected after 5-10 minutes.

🗳️🇨🇭 After upload — why you must carefully check the confirmation email

Once you upload your zipped eDoc file to Swissmedic’s server, it undergoes an automated technical check of the folder and file structure. Swissmedic will send you a technical confirmation email — but do not mistake this for a formal acknowledgment of your application’s regulatory completeness.

For example, one of my submissions passed the technical upload but I misread the email as a formal acceptance. This mistake cost me nearly a month waiting for a reply that would never come, as the file had never entered the actual review pipeline. Likewise, a minor directory structure violation in another case cost me two additional weeks.

✅ Therefore, always open and carefully read the confirmation email to understand whether your upload merely passed the file system check or was actually queued for regulatory review.

By following these lessons learned, you can avoid unnecessary delays and extreme frustration in getting your Swissmedic authorization for your MR research.

🇨🇭Submission at Swissmedic

Before you submit to Swissmedic you may also consult the video with instructions:

Videoanleitung – Einreichung Gesuche und Meldungen von klinischen Versuchen Medizinprodukte

🇪🇺 Similar Procedures in the EU

For the EU, the process is governed by the Medical Device Regulation (EU) 2017/745 (MDR),
with equivalent GSPR (General Safety and Performance Requirements), risk assessments, and clinical evaluation. In the post Regulatory Requirements for Interventional MRI/MRS Device Trials in the EU you find country specific references to the local competent agencies like Swissmedic of EU-member states. A more detailed text you find in this post.

 

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