Part 5: Regulations under Parts 1, 2, 3 and 4 Section 45: Consultation
This section sets out the consultation requirements that must be met before regulations are made under Parts 1, 2, 3 and 4 of the Act.
	Subsection (1) creates a duty to carry out a public consultation. It provides that before regulations are made under Parts 1, 2, 3 and 4, public consultation must take place. The duty is placed on the "relevant authority" which is defined in subsection (6).
	Subsection (2) creates a duty to consult the Welsh Ministers, the Scottish Ministers, the Department of Health in Northern Ireland, and any other persons as the Secretary of State considers appropriate before making regulations under section 19(1) about the establishment and operation of information systems in relation to medical devices. Section 19(1) provides a power to make UK-wide regulations establishing UK-wide information systems. Given those information systems will use information from healthcare providers throughout the UK for purposes that relate to both devolved and reserved matters, it is appropriate in this particular situation that the Secretary of State consults the devolved administrations when making regulations under this section.
	Subsection (3) provides that a summary of the relevant authority’s assessment of the matters mentioned in sections 2, 11 and 17 must be included in the consultation document ahead of making any regulations under sections 2(1), 11(1) or 17(1). For example, this means that if the Secretary of State proposed policy changes that would require regulations under section 2, the consultation document must include a summary of the Secretary of State’s assessment of the matters in section 2, which includes whether proposed regulatory changes would contribute to the objective of safeguarding public health and if proposed changes may have an impact on the safety of medicines, an initial assessment of whether the benefits of those regulations would outweigh the risks.
	Subsection (4) provides that the consultation duty does not apply in relation to regulations made in reliance on section 7 or section 18 (which can dis-apply provisions relating to human medicines and medical devices respectively where there is a risk of serious harm to health), provided the regulations contain a declaration that they are required urgently due to an imminent risk of serious harm to health.
	Subsection (5) provides that consultation carried out before the Act is passed may satisfy the duty to consult.
	Subsection (6) provides a definition for the term "relevant authority" as used in section 45.