Explanatory note

These Regulations are made under section 45C, 45F(2) and 45(P) of the Public Health (Control of Disease) Act 1984 implementing temporary arrangements to facilitate the production and supply of PPE during the Covid-19 crisis. These arrangements are similar to the proposals in the European Commission’s Recommendation 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat ((OJ L 79I, 16.3.20 p. 1-5), but the arrangements in these Regulations are specific to Wales and may only be relied on if the HSE has authorised them by a specified date and come into force on IP completion day.

Regulation 2 permits PPE to be placed on the market while it is undergoing conformity assessment procedures but before these have been completed and any conformity marking has been affixed. Regulation 3 permits PPE to be procured without undergoing conformity assessment procedures and conformity marking being affixed but this must only be made available to healthcare and frontline workers. In both cases, the PPE must have been assessed by the HSE and found to be compliant with the essential health and safety requirements in Annex II of Regulation 2016/425/EU of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (as amended and retained in UK law). Where the conditions are met, the obligations in Regulation 2016/425 will be treated as satisfied for the purposes of the Personal Protective Equipment (Enforcement) Regulations 2018 (S.I. 2018/390) and in respect of PPE for healthcare workers and other frontline workers, the market surveillance authority will not require the non-compliance to be brought to an end. This is solely in cases where the conformity assessment procedure has not been completed and the conformity mark has not been affixed due to reliance on regulation 2 or 3 of these Regulations.

The Welsh Ministers’ Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result, a regulatory impact assessment has not been prepared as to the likely cost and benefit of complying with these Regulations.