PART 4

Medical devices
CHAPTER 3

Enforcement

Enforcement notices

Compliance notices
21
1
This section applies where the enforcement authority has reasonable grounds to suspect that a person involved in marketing or supplying a medical device is not complying with a medical devices provision.
1A
In this Chapter, “medical devices provision” means a provision in—
a
regulations under section 15(1),
b
the Medical Devices Regulations 2002 (
S.I. 2002/618
),
c
the Medical Devices (Northern Ireland Protocol) Regulations 2021, or
d
the EU Medical Devices Regulations.
2
The enforcement authority may serve a notice (“a compliance notice”) on the person—
a
identifying the medical devices provision with which the person is suspected not to be complying,
b
setting out the enforcement authority's grounds for suspecting that the person is not complying with the provision,
c
requiring the person to comply with the provision within a specified period,
d
requiring the person within a specified period to provide evidence to the satisfaction of the enforcement authority that the person is complying with the provision, and
e
requiring the person within a specified period to take any other measures that may be specified in order to comply with the provision.
3
A period specified in reliance on subsection (2)(c), (d) or (e) must be a period of at least 28 days beginning with the day on which the notice is served.
4
The enforcement authority may vary or revoke a compliance notice.
5
Where the person mentioned in subsection (1) is a manufacturer, a notice under subsection (2) may be served on the manufacturer or on another person who has been designated by the manufacturer to act as the manufacturer's representative (or both).
6
In this section, “
specified
” means specified in the compliance notice.
S. 21 in force at 26.5.2021 by S.I. 2021/610, reg. 2(a)
S. 21(1A) inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 28(3)
S. 21(1A)(d) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 6