(xiv) Other active medical devices An active medical device to which provisions of sub-paragraphs (xii) and (xiii) do not apply shall be assigned to Class A. (xv) Medical devices incorporating medicinal products (a) Subject to clause (b), a medical device shall be assigned to Class D, if it incorporates as an integral part a substance which, — (1) if used separately, may be considered to be a medi ...

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

Records of validation shall be maintained. 7.5.2.2 Particular requirements for sterile medical devices The manufacturer shall establish documented procedures for the validation of sterilization processes. Sterilization processes shall be validated prior to initial use. The records of validation of each sterilization process shall be maintained. 7.5.3 Identification and traceability: