PART 4

Medical devices
CHAPTER 1

Regulations: general

Power to make regulations about medical devices
15
1
The Secretary of State may by regulations make provision specified in sections 16 to 18 amending or supplementing the Medical Devices Regulations 2002 (S.I. 2002/618).
2
In making regulations under subsection (1), the Secretary of State's overarching objective must be safeguarding public health.
3
In considering whether regulations under subsection (1) would contribute to this objective, the Secretary of State must have regard to—
a
the safety of medical devices;
b
the availability of medical devices;
c
the likelihood of the United Kingdom being seen as a favourable place in which to—
i
carry out research relating to medical devices,
ii
develop medical devices, or
iii
manufacture or supply medical devices.
4
Where regulations under subsection (1) may have an impact on the safety of medical devices, the Secretary of State may make the regulations only if the Secretary of State considers that the benefits of doing so outweigh the risks.