SCHEDULES
SCHEDULE 4Persons who are exempt
PART 2Definitions of persons who are exempt, conditions, limitations of exemption and savings
31. Clinical investigation worker
52.
A person who has travelled to the United Kingdom—
(a)
to conduct a “clinical investigation” within the meaning of the Medical Devices Regulations 2002 M1 F1and/or Regulation (EU) 2017/745 of the European Parliament and of the Council of 5th April 2017,
(b)
to undertake such activities as are necessary or expedient to prepare for the conduct of a clinical investigation, or
(c)
to carry out any other necessary compliance activity in relation to a clinical investigation,
where none of these functions can be carried out remotely.