Introduction to AI-aided proposal generation

🇨🇭🇪🇺 Introduction to AI-Aided Document Creation for Single-Center MRI Trials with Non CE-marked Devices and/or Pulse-Sequences

The specialized GPT-s below focuses on preparing documents exclusively for single-center MRI/MRS clinical investigations that involve non CE-marked pulse sequences (like WIP or IDEA sequences) and/or non CE-marked hardware (like site-built RF coils). This includes trials typically requiring Category C2 approvals under Swiss ClinO-MD and Annex XV MDR submissions in the EU.

1. Documents for Competent Authorities (CA)

1.1 European Union 🇪🇺 (single-center)

In the EU under MDR 2017/745, single-center clinical investigations with non CE-marked software or hardware must still meet strict Annex XV documentation.
This GPT-s help create:

• MDR Annex XV Application Dossier (single site data, device info, investigator data)
• General Safety and Performance Requirements (GSPR) Checklist (Annex I)
• Risk Management Files: Plan, Analysis (FMEA/FTA), and Report (ISO 14971)
• Investigator’s Brochure (IB)
• Clinical Evaluation Plan (CEP) and Report (CER)

1.2 Switzerland🇨🇭(single-center)

For single-center trials involving non CE-marked devices (category C2), Switzerland requires simultaneous applications to Swissmedic and the cantonal ethics committee under ClinO-MD. Relevant information you find on the Swissmedic website. Swissmedic requires applications to be submitted in the eDoc format.

These GPT-s helps create:

• Swissmedic application (forms and eDok structure, including risk management & IB)
• CIP (Clinical Investigation Plan) explicitly disclosing non CE-mark status
• Risk-adapted recruitment & interim safety analysis plans as per Article 16
• Device Deficiency, SAE and materiovigilance reporting templates.

For details on preparing your submission files according to the required electronic structure, see
Swissmedic eDok structure for clinical investigations.

2. Documents for Ethics Committees (CIP)

Single-center ethics proposals are essential. This GPT generates:

• Clinical Investigation Plan (CIP / Protocol) with subject protections, stopping rules, on-site supervision (ISO 14155)
• Investigator’s Brochure (IB) clearly indicating investigational, non CE-marked nature
• Risk Management summary tailored to subject safety (per ISO 14155, ISO 14971, ClinO-MD, MDR)
• Patient Information Sheet & Informed Consent (PIS/ICF), with clear cautions for non CE-marked use

3. Documents this GPT generates for these trials

The following GPT-s may help you to automate first drafts of the following documents:

• ✅ Clinical Investigation Plan (CIP)
• ✅ Investigator’s Brochure (IB)
• ✅ Risk Management Plan, Analysis (FMEA/FTA), and Report (ISO 14971)
• ✅ GSPR Checklist (MDR Annex I)
• ✅ Clinical Evaluation Plan & Report (CEP/CER)
• ✅ SAE & Device Deficiency Reporting Templates (per ClinO-MD Articles 33–34)
• ✅ Full Swissmedic + Ethics submission bundles (category C2)

4. Comparison of Requirements: Switzerland vs EU (Single‑Center MRI Trials)

Requirement	Switzerland	EU Member States (examples with ePortals)
Regulation	ClinO‑MD HRA & TPA	EU MDR 2017/745 (Annex XV & I) MDCG Q&A
CA Application	Swissmedic (C2) via eDok/eMessage	Germany (DIMDI/BfArM Portal) France (ANSM Vigilance & CI) Italy (AIFA CTR Portal) Spain (AEMPS MDR Guidance) Belgium (FAMHP Portal) Portugal (Infarmed MD FAQ) Other countries follow MDR via their national CA websites
Ethics Submission	Cantonal EC via BASEC	National/local EC; Netherlands via CCMO/MREC; others aligned to MDR + local GCP
Core Docs	CIP, IB, ISO 14971 risk files, SAE/device deficiency (ClinO‑MD Art. 33)	CIP, IB (MDR Annex XV), GSPR (Annex I), CEP/CER, ISO 14971
Safety Oversight	Risk mgmt Art. 16 + SAE reporting Art. 33	MDR Annex I, ISO 14155, ISO 14971; local vigilance rules
Submission Format	eDok folder via eMessage	Country portals: DIMDI (DE), ANSM (FR), AIFA (IT), AEMPS (ES), FAMHP (BE), Infarmed (PT)

References ensuring compliance

• Swiss ClinO-MD Arts. 6, 16–20, Annex 1 (category C2)
• EU MDR 2017/745 Annex XV & I
• ISO 14971 (Risk Management) &
  ISO 14155 (Clinical investigations)
• IEC 60601-2-33 (MRI SAR & PNS safety)
• ISMRM RF hardware safety recommendations

Conclusion

This system is currently optimized for single-center MRI/MRS trials with investigational non CE-marked pulse sequences and hardware. In future, we plan to expand to multi-center submissions.
Contact us to see how this GPT can speed up preparation of your Swissmedic  [or local responsible EU-CA]  C2 or EU MDR Annex XV files.