Part 1 Monetary Penalties

SCHEDULE 2 Medical Devices: Civil Sanctions

Section 31

Part 1 Monetary Penalties

Imposition of monetary penalty

1

(1)     The Secretary of State may impose a monetary penalty on a person if satisfied beyond reasonable doubt that the person has committed an offence under—

(a)     section 28 (offence of breaching enforcement notice), . . .

(b)     regulation 60A of the Medical Devices Regulations 2002 (SI 2002/618) (offence of breaching certain provisions in the Regulations)[, or

(c)     regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021 (offence of breaching certain provisions)].

(2)     In this Schedule “monetary penalty†means a requirement to pay to the Secretary of State a penalty of an amount determined by the Secretary of State.

Notices, representations and appeals etc

2

(1)     Where the Secretary of State proposes to impose a monetary penalty on a person, the Secretary of State must serve on the person a notice of what is proposed.

(2)     A notice under sub-paragraph (1) must offer the person the opportunity to avoid liability in relation to a monetary

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