Regulation 11

the supply no later than 31st December 2011 of an unregistered Class A or B medical device —

which is not an implantable medical device;

which is not, or cannot be, licensed as a medicinal product under the Medicines Act 1975 before 10th August 2010; and

in respect of which the Authority does not at any time receive any information concerning, and does not at any time become aware of, any defect or adverse effect under section 42(2) of the Act;

the supply on or after 1st January 2012, but before 1st June 2018, of an unregistered Class A or B medical device (but not an unregistered Class A medical device supplied on or after 1st May 2012 in accordance with the requirements specified in regulation 10B) —

which is listed on the Class A or B Medical Device Transition List as published on the Authority’s website on or before 1st January 2012;

which qualifies for evaluation under an abridged evaluation process referred to in regulation 26;

which is not, or cannot be, licensed as a medicinal product under the Medicines Act 1975 before 10th August 2010;

which complies with the First Schedule as in force immediately before 1 June 2018;

in respect of which the Authority does not at any time receive any information concerning, and does not at any time become aware of, any defect or adverse effect under section 42(2) of the Act; and

in respect of which the Authority receives, before 1st December 2011, and does not at any time reject, an application for registration as a Class A or B medical device;

the supply no later than 31st July 2011 of an unregistered Class C or D medical device —

which is not an implantable medical device; and

in respect of which a licence to deal with the medical device has been granted under section 6 or 7 of the Radiation Protection Act 2007 and has not expired;

the supply at any time of an unregistered Class C or D medical device —

which is listed on the Class C or D Medical Device Transition List as published on the Authority’s website on or before 10th August 2010;

which qualifies for evaluation under an abridged evaluation process referred to in regulation 26;

which, if it is an implantable medical device, has been approved, before 1st January 2011, by at least 2 competent regulatory agencies referred to in regulation 26;

which complies with the First Schedule as in force immediately before 1 June 2018;

in respect of which the Authority does not at any time receive any information concerning, and does not at any time become aware of, any defect or adverse effect under section 42(2) of the Act; and

in respect of which the Authority receives, and does not at any time reject, an application for registration as a Class C or D medical device; (e)the retail supply, at any time, by a retail supplier of an unregistered medical device that the retail supplier has taken possession of before 10th August 2010; (f) the retail supply, at any time, by a retail supplier of an unregistered Class A or B medical device that the retail supplier has taken possession of on or after 10th August 2010 but before 5th April 2012;

the supply on or after 1st September 2012, but before 1st June 2018, of an unregistered Class A or B medical device, not being an unregistered Class A medical device supplied in accordance with the requirements in regulation 10B, which is listed on the Class A or B Medical Device Transition List as published on the Authority’s website; and

the supply on or after 1st September 2012, but before 1st June 2018, of an unregistered Class C or D medical device which is listed on the Class C or D Medical Device Transition List as published on the Authority’s website.