PART 4

Medical devices
CHAPTER 1

Regulations: general

Fees, information, offences
17
1
Regulations under section 15(1) may make provision—
a
about the charging of fees in connection with the exercise of a function conferred by a medical devices provision, including the charging of fees by a person appointed under provision made in reliance on section 16(1)(c),
b
about the recording of information regarding the safety and performance, including the clinical effectiveness, of medical devices, including the extent to which relevant requirements that apply in relation to the devices are met,
c
permitting or requiring such information to be disclosed to the Secretary of State or to a person appointed under provision made in reliance on section 16(1)(c), or
d
amending the Schedule to the Medical Devices Regulations 2002 (S.I. 2002/618) inserted by Schedule 3 to this Act (list of regulations breach of which is an offence under regulation 60A).
2
In this Chapter, “medical devices provision” means a provision in—
a
regulations under section 15(1), or
b
the Medical Devices Regulations 2002.
S. 17(2) in force at 11.2.2021 see s. 50(1)(g)
Words in s. 17(2) substituted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 28(2)