SCHEDULES

SCHEDULE 2Medical devices: civil sanctions

PART 1Monetary penalties

Monetary penalties: criminal proceedings and conviction

4

1

Where a notice under paragraph 2(1) is served on a person—

a

no criminal proceedings for an F1offence under—

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,

may be instituted against the person in respect of the act or omission to which the notice relates before the end of the period within which the person’s liability may be discharged as mentioned in paragraph 2(2) (see paragraph 3(2)(a));

b

if the liability is so discharged, the person may not at any time be convicted of an offence under F2the provisions mentioned in paragraph (a) in relation to that act or omission.

2

A person on whom a monetary penalty is imposed may not at any time be convicted of an offence under F3any of the provisions mentioned in sub-paragraph (1)(a) in respect of the act or omission giving rise to the penalty.