The guidance aims to assist sponsors in anticipating questions from competent authorities during the assessment of clinical investigation applications and emphasizes the importance of a well-prepared CIP for the successful conduct of the investigation. It aligns with the legally mandated content outlined in Section 3 of Chapter II of Annex XV of the MDR, as well as other relevant sections of the regulation emphasizing adherence to good clinical practice.
The guidance adopts the numbering system of the MDR for easy cross-referencing with legal requirements.