SCHEDULES

SCHEDULE 4Persons who are exempt

PART 2Definitions of persons who are exempt, conditions, limitations of exemption and savings

31. Clinical investigation worker

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A person who has travelled to the United Kingdom—

a

to conduct a “clinical investigation” within the meaning of the Medical Devices Regulations 2002 M1F1and/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.