Sponsors conducting clinical investigations under the MDR are required to submit a thorough Clinical Investigation Plan (CIP) that aligns with the latest scientific knowledge and relevant standards. While the CIP must meet the legal requirements outlined in Annex XV of the MDR, this guidance document provides detailed instructions to assist sponsors in preparing plans that fulfill regulatory expectations and streamline the assessment process by competent authorities.
The following necessary information is preferred to be contained in the CIP:

1. General introduction, e.g. the title of the clinical investigation, version and date of the CIP, Abbreviations and acronyms, an overall synopsis of the clinical investigation and so on.
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. Statements of compliance
13. Informed consent process
14. Adverse events, adverse device effects and device deficiencies
15. End, suspension, or premature termination of the clinical investigation
16. Arrangements for subjects following participation
17. Publication policy
18. Technical and functional features of the device
19. Bibliography

 

For further details, please consult the reference provided. A template for the clinical investigation plan synopsis is available in the provided reference. 

 

 

Reference: 
MDCG 2024-3 - Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices