SCHEDULES

Prospective

SCHEDULE 2U.K.Medical devices: civil sanctions

PART 2 U.K.Enforcement undertakings

5(1)This paragraph applies where—U.K.

(a)the Secretary of State has reasonable grounds to suspect that a person has committed an [F1offence under— section 28 or regulation 60A of the Medical Devices Regulations 2002,

(i)section 28,

(ii)regulation 60A of the Medical Devices Regulations 2002, or

(iii)regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021,]

(b)the person offers an undertaking (an “enforcement undertaking”) to take specified action within a specified period,

(c)the action specified is—

(i)action to secure that the offence does not continue or recur, or

(ii)action of a description set out in supplementary regulations (see Part 4 of this Schedule), and

(d)the Secretary of State accepts the undertaking.

(2)Unless the person fails to comply with the undertaking or any part of it—

(a)the person may not at any time be convicted of an offence under [F2any of the provisions mentioned in sub-paragraph (1)(a) in respect of the act or omission to which the undertaking relates;]

(b)the Secretary of State may not impose on the person any monetary penalty that the Secretary of State would otherwise have power to impose by virtue of paragraph 1 in respect of that act or omission.

Textual Amendments