The manufacturer shall establish and maintain a record for each batch of medical device or in vitro diagnostic medical devices that provides traceability and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved. 7.5.1.2 Control of production and service provision—Specific requirements 7.5.1.2.1 Cleanliness of product and contamin ...

(xii) Active therapeutic medica I devices for administering or exchanging energy (a) Subject to clause (b), an active therapeutic medical device shall be assigned to Class B, if it is intended for the administration or exchange of energy to or with a human body. (b) An active therapeutic medical device referred to in (a) shall be assigned to Class C, if the administration or exchange of energy may ...