PART 4

Medical devices
CHAPTER 3

Enforcement

Recall of medical device by enforcement authority

Recall of medical device by enforcement authority
35
1
This section applies where the enforcement authority considers that—
a
it is necessary to restrict the availability of a medical device in order to protect health or safety, and
b
the device has already been supplied or made available to members of the public.
2
The authority may take such steps as it considers necessary to organise the return of the device to the authority or to another person (whether or not it issues a safety notice under section 23 requiring another person to organise or cooperate in organising the recall of the device).
3
The authority may take steps in reliance on subsection (2) only if satisfied that no alternative steps that did not involve recalling the device would sufficiently protect health or safety as mentioned in subsection (1).
S. 35 in force at 26.5.2021 by S.I. 2021/610, reg. 2(a)