The manufacturer shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. To the extent required for traceability, the manufacturer shall maintain documents and records of relevant purchasing information. 7.4.3 Verification of purchased product: The manufacturer shall establish and implement the inspection or other activities necessary for ensuring ...

(2) to be life supporting or life sustaining; (3) to be an active medical device; (4) to be wholly or mainly absorbed by the human body; (5) for the administration of any medicinal product; or (6) to be a breast implant. (d) Subject to clause (b), a long term use medical device shall be assigned to Class D, if it is intended to undergo chemical change in the body.