The Medical Devices (Northern Ireland Protocol) Regulations 2021

Offence of breaching certain provisions

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23.—(1) A person commits an offence if the person contravenes a prohibition or fails to comply with a requirement in a provision of the regulations listed in Table 1 or the Articles listed in Table 2 in Schedule 3 to these Regulations.

(2) A person guilty of an offence under paragraph (1) is liable on summary conviction to imprisonment for a term not exceeding 6 months, to a fine not exceeding level 5 on the standard scale or to both.

(3) In respect of an offence under this regulation, a magistrates’ court in Northern Ireland may hear and determine any complaint made before the earlier of—

(a)the end of the period of 1 year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor, and

(b)the end of the period of 3 years beginning with the day on which the offence was committed.

(4) For the purposes of paragraph (3)(a)—

(a)a certificate signed by or on behalf of the prosecutor and stating the date on which such evidence came to the prosecutor’s knowledge is conclusive evidence of that fact, and

(b)a certificate stating that matter and purporting to be so signed is to be treated as so signed until the contrary is proved.