SCHEDULES
SCHEDULE 2

Medical devices: civil sanctions
PART 4

Power to make supplementary provision etc by regulations

Enforcement undertakings
11
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.