2024-03

This guidance document is not legally binding. It has been developed following contribution from national competent authorities, industry and relevant stakeholders and it should therefore be recognised as best practice. It has been written to support sponsors developing their CIP by describing in greater detail what type of information is expected in the respective CIP sections, to pre-empt questions from the competent authorities during the assessment of the clinical investigation application. Moreover, a CIP with the appropriate content will be instrumental in the conduct of the clinical investigation.

The document and appendix can be downloaded in our library

Source: European Commission