You may have heard about the introduction of the new UK Conformity Assessed (UKCA) marking - a new UK product marking system used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods that previously required the CE marking. Its arrival is both straightforward yet a little convoluted.
In this blog, we aim to share light on what this means to you from a PPE perspective.
Why Was It Introduced?
In late December 2020, at the end of the agreed transition period following the UK's departure from the EU (Brexit), any UK-based notified body that issued EU-type examination certificates ceased to be an EU notified body. The consequence of this was that any UK issued EU type-examination certificates ceased to be valid.
As a result, for EU type-examination certificates to be valid in the UK from 2021 onwards, they needed to be re-issued by an EU-based notified body. So, in the run-up to Brexit, affected manufacturers began to move their certifications to EU-27 or EEA based notified bodies to ensure that their products' CE marking remained valid across the EU-27, EEA and the UK.
But when the free trade deal between the UK government and the European Union came into force on January 1st 2021, it did not contain any 'mutual recognition agreement' for certification. It was as a result of this omission that the UK Conformity Assessment and the UKCA mark came into being.
What Does That Mean?
UK based notified bodies automatically became UK Approved Bodies for the purpose of UKCA. The requirements for UKCA are currently a direct copy of previous EU directives and regulations at this stage, but there may be divergence over time in the future.
And despite its name, the UKCA will only apply to the countries of Great Britain, namely England, Scotland and Wales. Northern Ireland remains broadly aligned with EU requirements in order to maintain a frictionless border with the Republic of Ireland and has unfettered access for qualifying Northern Ireland goods to the rest of the UK market.
BSI, the UK's national standards body, retains membership of the officially recognised European Standardisation organisations - the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (CENELEC) for 2021 and continues to develop and contribute to standards.
European standards (EN standards) will still be adopted and integrated into the UK national catalogue with identical technical content to all other European standards used by CEN and CENELEC members. UK designated standards, as they are now known, may temporarily lag behind ENs that have been updated since the beginning of 2021 while the new UK system is fully ironed out.
Having extended the initial timeframe to the end of 2022, in July 2022 the UK’s Department for Business, Energy & Industrial Strategy (BEIS) announced additional changes to the UKCA product regulation scheme which applies to the supply of PPE. Essentially, manufacturers of PPE with a valid EU type examination certificate issued before 1st January 2023 can now continue to place those products onto the UK market until the expiry date of that certificate.
Impact On PPE Markings/Labelling
A product's compliance with CE did not suddenly expire at the end of 2021 due to introducing the new UKCA requirements. In fact, CE markings will continue to be recognised in Great Britain until June 30th 2023.
Any PPE lawfully placed on the market by December 31st, 2022, with a CE marking, can continue to circulate within the Great Britain (GB) market after this date and until its certification expires. At this stage, there is no formally recognised endpoint for any PPE products already in the market in these timelines.
PPE lawfully placed on the GB market after this date (i.e., from January 1st 2023) and not already CE marked shall have to conform to UKCA requirements.
Until December 31st 2025, the UKCA marking may be affixed to a label attached to the PPE or a document accompanying the PPE rather than directly affixed to the PPE itself. This is a transitional measure to help allow manufacturers to adapt to the new requirements.
Impact On Medical Devices
As we have said, CE markings will continue to be recognised in Great Britain until June 30th 2023. But effective from January 1st 2021, all medical devices had to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). All of the Unigloves medical devices have been registered with the MHRA for a number of years already.
Unigloves Products
To ensure we are entirely in line with the latest regulations, Unigloves has completed UKCA certification for its products. You can view our medical gloves here.
