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

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Temporary arrangements for the making available of Covid PPE

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2.—(1) This regulation applies to Covid PPE only.

(2) Notwithstanding the requirements of Articles 8(2), 10(2) and 11(2) of the PPE Regulation, where the conditions set out in paragraph (3) are met, Covid PPE may be made available on the market by a relevant economic operator before—

(a)the applicable conformity assessment procedure has been carried out, and

(b)the UK marking has been affixed.

(3) The conditions referred to in paragraph (2) are that before an economic operator makes the Covid PPE available—

(a)the Covid PPE has been submitted for conformity assessment to an approved body, and

(b)after the Covid PPE has been submitted to an approved body, the HSE—

(i)has assessed the Covid PPE as compliant with the EHSR relevant to the assessment process, and

(ii)has notified an economic operator at any time before 1 April 2021 of the assessment that the Covid PPE is compliant with the EHSR against which it has been assessed.

(4) Where an economic operator relies on regulation 2A of the 2018 Regulations and submits Covid PPE to a notified body, a reference in this regulation to—

(a)the UK marking is to be read as a reference to the CE marking,

(b)an approved body is to be read as a reference to a notified body.

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