Conditions for permission to conduct of clinical performance evaluation After grant of permission referred to in sub-rule (5) of rule 59, the following conditions shall be complied with by the applicant, — (i) clinical performance evaluation shall be conducted in accordance with the approved clinical performance evaluation plan and Good Clinical Practices Guidelines; (ii) clinical performance eva ...

As part of design and development validation, the manufacturer shall perform clinical evaluations and/or evaluation of performance of the medical device or in vitro diagnostic medical devices. Note 1 : If a medical device or in vitro diagnostic medical devices can only be validated following assembly and installation at point of use, delivery is not