Medical Devices Regulations

37 No person shall sell a medical device from a lot of licensed in vitro diagnostic devices in respect of which terms and conditions were set out in the licence pursuant to section 36, unless

• (a) the results and protocol of any test performed on the device in accordance with those terms and conditions have been provided to the Minister; and

• (b) the Minister determines, on the basis of the information received under paragraph (a), that the device continues to meet the applicable requirements of sections 10 to 20.