MDCG Guidance on Clinical Investigation Plan

The Medical Devices Coordination Group (MDCG) released in March 2024 a new guidance on the content of the clinical investigation plan for clinical investigations of medical devices (MDCG 2024-3). This guidance follows the footsteps of other MDCG documents such as a Q&A on clinical investigation, a MDCG guidance on safety reporting in clinical investigation and an MDCG guidance on the content and structure of the clinical investigation report.

The MDCG 2024-3 guidance focuses on the clinical investigation plan, the document that sets out the rationale, objectives, design methodology, monitoring, record-keeping, and method of analysis for carrying out the clinical investigation. The clinical investigation plan allows competent authorities and ethics committees to assess whether the clinical investigation has been designed in a way where potential residual risks are justified.

This guidance sets the content of the clinical investigation plan covering, among others:

1. A general introduction
2. Identification and description of the investigational device
3. Benefits and risks of the investigational device, clinical procedures and clinical investigation
4. Relevance of the clinical investigation
5. Objectives and hypotheses
6. Design of the clinical investigation
7. Statistical design and analysis
8. Data management
9. Modifications of the CIP
10. Deviations from the CIP
11. Device accountability
12. Statement of compliance
13. Informed consent process
14. Adverse events, adverse device effects and device deficiencies
15. Etc.

Finally, the MDCG document includes a summary template for manufacturers to use.

Do you wish to know more about MDCG guidances? You can find these and other MDCG guidances in our MDCG – MDR section!