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Category: EU-MDR-CA
Format and instructions of an Investigators’ Brochure (IB)
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How to use the IB-creator GPT
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Build a regulator-ready Clinical Investitor Plan for MRI/MRS trials
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The CIP-creator GPT input yaml file
Detailed Description of CIP-Intake YAML This page explains the CIP-Intake YAML used by the MR-clinical-trial-CIP-Creator GPT to validate your inputs and generate a regulator-aligned Clinical Investigation Plan (CIP) skeleton for CH and/or EU submissions. Download YAML Empty example.yaml file What the YAML is for File rules & formatting Minimal valid example Full scaffold… Continue reading The CIP-creator GPT input yaml file
Competent Agencies for Medical Device Trials in EU-Memberstates
Overview in MDR Article 82 Context Interventional clinical investigations of non–CE-marked MRI and MR spectroscopy devices (e.g. novel RF coils, pulse sequences) are governed by the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745). Specifically, if these trials are not undertaken to support CE-marking of the device (i.e. they are “other” clinical investigations under MDR… Continue reading Competent Agencies for Medical Device Trials in EU-Memberstates
How to apply for a CA Approval in the EU
🇪🇺 How to apply for a Competent Agency (CA) Approval in the EU for your MR-research When planning a magnetic resonance (MR) research study in the EU using non-CE-marked RF hardware or novel pulse sequences, you must obtain approval from the national Competent Authority (CA) in each country where the study will run. This CA… Continue reading How to apply for a CA Approval in the EU
Ethics proposal — The Clinical Investigation Plan (CIP)
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Developing a Risk Management Report for MR Medical Device Trials
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Investigator Brochure Builder-GPT
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