SCHEDULES

Prospective

SCHEDULE 2 U.K. Medical devices: civil sanctions

PART 4 U.K. Power to make supplementary provision etc by regulations

Enforcement undertakings U.K.

11 U.K. Supplementary regulations may make provision of any of the following sorts in relation to an enforcement undertaking—

(a) provision as to the procedure for entering into an undertaking;

(b) provision as to the terms of an undertaking;

(c) provision as to publication of an undertaking by the Secretary of State;

(d) provision as to variation of an undertaking;

(e) provision as to circumstances in which a person may be regarded as having complied with an undertaking;

(f) provision as to monitoring by the Secretary of State of compliance with an undertaking;

(g) provision as to certification by the Secretary of State that an undertaking has been complied with;

(h) provision for appeals against refusal to give such certification;

(i) in a case where a person has given inaccurate, misleading or incomplete information in relation to an undertaking, provision for the person to be regarded as not having complied with it;

(j) in a case where a person has complied partly but not fully with an undertaking, provision for that part-compliance to be taken into account in the imposition of any criminal or other sanction on the person.