Jurisdiction: Scoland
Commencement: 1st February 2021
These Regulations introduce temporary arrangements to ease conformity requirements for PPE products that are made and supplied for use during the Coronavirus (Covid-19) crisis, to reduce the public health risks presented by Coronavirus. PPE that usually requires a conformity assessment can be provided to healthcare workers or specified frontline health and care sector workers without having completed the conformity assessment process.
Temporary arrangements applying to manufacturers, importers and distributors in relation to the conformity assessment process will continue in Scotland to speed up the supply of essential Covid-19 related personal protective equipment (PPE).
Temporary arrangements for PPE were introduced by Commission Recommendation 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. These temporary arrangements were implemented in the UK on March 2020. As Commission Recommendation 2020/403 has not been carried over into domestic UK law at the end of the Brexit transition period, new requirements are made to continue the easements for as long as they are needed. These Regulations make specific arrangements for the supply of emergency Covid-19 PPE after the end of the transition period.
These arrangements ease the regulatory requirements for conformity assessments for certain categories of PPE for a limited time, to increase the supply of essential Covid-19 related PPE on the UK market and for healthcare and specified health and care sector frontline workers.
The arrangements are time limited and require an assessment to be conducted by the Health and Safety Executive (HSE) by specified dates (see below).
PPE undergoing conformity assessment procedures that are yet to receive conformity marking (e.g. a UK or CE mark) can be made available for purchase in the UK.
To be eligible, the PPE must be needed for the protection from Coronavirus and the conformity assessment procedure must have been initiated. The HSE must have certified the PPE as compliant with the requirements laid out in Regulation 2016/425/EU on personal protective equipment.
Please note: The HSE will only undertake this assessment and certification process until 31st March 2021. After 31st March 2021 the usual conformity assessment requirements which applied before March 2020 will apply to unassessed PPE.
PPE that usually requires a conformity assessment can be provided to healthcare workers or specified frontline health and care sector workers without having completed the conformity assessment process.
The PPE must be needed for the protection from Coronavirus and it must have been purchased by, or on behalf of the Scottish Ministers or a health service body and only for the use of healthcare or specified frontline health and care sector workers.
Where PPE is made available to healthcare workers and frontline workers, the PPE must be assessed by the HSE and found to be compliant with the safety requirements specified in Annex II of Regulation 2016/425/EU on personal protective equipment.
Please note: The HSE will only undertake this assessment and certification process until 30th June 2021. After 30th June 2021, the usual conformity assessment requirements, that applied before March 2020 will apply to unassessed PPE.
Manufacturers, importers or distributors supplying PPE under these temporary arrangements, that do not complete a conformity assessment and/or attach the conformity marking will not be guilty of an offence.
PPE that has been assessed under Commission Recommendation 2020/403 does not affect the validity of any HSE assessment or conditions set by the HSE in respect of the assessment of PPE.
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