FEATURE
MARK TO PROVE IT
Now that the United Kingdom has left the European Union, there are new requirements for the marking of PPE for sale in the UK. Here, SATRA outlines the latest information regarding these legal changes.
The UK left the EU on 31 January 2020, entering a transition phase where EU legislation still applied until the end of December 2020. Since that time, the UK has adopted its own legislation with regard to placing personal protective equipment (PPE) goods onto the UK market.
The European PPE Regulation (EU) 2016/425 has been brought into UK law to become the UK PPE Regulation (EU) 2016/425 (as retained in UK law and amended). For category II and III PPE, third-party certification is required and all categories of PPE need to be marked with a new UKCA (United Kingdom Conformity Assessed) mark.
The process is similar to that currently used for CE marking, requiring the manufacturer to work with a UK ‘Approved Body’ for categories II and III. While the UK PPE Regulation (EU) 2016/425 (as retained in UK law and amended) is a copy of EU law, it is expected that, over time, there will be a gradual divergence away from such rulings.
SATRA received Approved Body status in the UK on 1 January 2021 (reference AB0321) and can now carry out conformity assessment work in support of UKCA marking. Manufacturers of PPE can certify their products for sale in the EU with a CE mark by working with our subsidiary SATRA Technology Europe Limited (number 2777) in Ireland, an EU27 state. SATRA is also able to conduct conformity assessment work for EU manufacturers who want to UKCA mark their products for sale in the UK.
To sell category II and III PPE in both the UK and EU 27 member states, a manufacturer will need an EU type-examination certificate under Regulation (EU) 2016/425 from an EU Notified Body such as SATRA Technology Europe Limited, plus a UKCA certificate
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from a UK Approved Body – for instance, SATRA Technology Centre Limited.
SATRA is well placed to provide both certifications and our staff in both Ireland and the UK will be able to organise this for our customers. Although it is part of the UK, products being sold into Northern Ireland will still require CE marking, and not the new UKCA mark.
The UKCA mark and CE mark will coexist briefly, with UKCA and CE marked products both eligible for sale in the UK in 2021. However, products CE marked by a UK Notified Body are no longer eligible for sale in Europe and will need to be remarked by an EU based Notified Body. In 2022, the UKCA mark can be affixed to the outside/packaging of a product and still be placed on the UK market. In 2023, this rule is tightened to only allow the UKCA mark to be affixed where otherwise impossible.
It is important to note that the UK’s withdrawal from the EU did not affect the validity of existing or future test reports issued by SATRA’s testing facilities in the UK. These will continue to be accepted for certification purposes by SATRA Technology Europe Limited and other PPE Notified Bodies. This is because testing that supports PPE certification does not need to be carried out in the EU.
The testing laboratories at SATRA are accredited by the United Kingdom Accreditation Service (UKAS) to the internationally-recognised standard ISO/IEC 17025:2017 – ‘General requirements for the competence of testing and calibration laboratories.’ UKAS, along with other European Accreditation Bodies, is a signatory of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement.
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