Part 4: Medical Devices Chapter 1: Regulations: General Section 18: Emergencies
Section 18 allows amending and supplementary regulations to be made under section 15(1) about the relaxation of regulatory requirements in circumstances where there is a need to protect the public from a threat of serious harm to health. The Covid-19 pandemic would be an example of such circumstances.
	By way of example, regulations made in reliance on section 18 could allow for certain devices to be supplied notwithstanding that an assessment of compliance with a requirement has not yet taken place. Subsections (2) and (3) provide that the relaxing of a regulatory requirement could be made subject to conditions. Conditions may be found in regulatory provisions or a time-limited protocol that is published by the Secretary of State. Conditions can be important safeguards and may need to be bespoke. The use of protocols may be the most effective means to communicate the applicable conditions to healthcare and other professions accustomed to operating within the comprehensive regulatory regime governing medical devices.