The Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (Scotland) Regulations 2021

Enforcement

4.—(1) Where an economic operator has made Covid PPE available in reliance on regulations 2 or 3, the economic operator will not be treated as having contravened the requirements and obligations set out in Articles 8(2), 10(2) or 11(2) of the PPE Regulation for the purposes of regulation 7(1) of the 2018 Regulations if—

(a) the applicable conformity assessment procedure has not been completed in relation to the Covid PPE, or

(b) the UK marking has not been affixed to the Covid PPE.

(2) Paragraph (3) applies where an economic operator has made Covid PPE available in reliance on regulation 3 and—

(a) the applicable conformity assessment procedure has not been completed in relation to the Covid PPE, or

(b) the Covid PPE does not bear the UK marking.

(3) Where this paragraph apples, a failure by an economic operator to take the action required under Article 41(1)(b), (c) and (d) of the PPE Regulation will not be treated as non-compliance with the PPE Regulation and the economic operator will not be guilty of an offence for the purposes of regulation 7(3) of the 2018 Regulations.

(4) Where PPE has been assessed by the HSE before IP completion day, pursuant to the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat(1), these Regulations do not affect the validity of that HSE assessment.

(1)

OJ L 79I, 16.3.2020, p.1.