4C. Import of medical device for use in clinical research

A person may import, without holding an importer’s licence as required under section 13(1) of the Act, any medical device if —

the planned use for the medical device is a clinical purpose in any clinical research; and

the person imports the device —

after the person has given notice to the Authority of the import in accordance with regulation 51; or

in accordance with a permission given by the licensing authority under the Medicines Act 1975 before 1 November 2016 for the import on or after that date.