The International Medical Device Regulators Forum (IMDRF) has issued a number of documents on clinical evaluation for consultation:
The first of these provides general information on clinical evaluations such as what they are, when they are undertaken, why they are important, the process for carrying them out and how detailed they should be. The second provides details on clinical investigations, clinical data, clinical evaluation and clinical evidence. The third paper sets out general principles on determining the need for a clinical investigation, clinical investigation design, as well as ethical considerations. The consultation closes on Wednesday 5 June 2019.