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UKCA marking of PPE products – the current position
SATRA offers CE and UKCA conformity assessment for PPE being placed on the EU and UK markets.
Image © iStockPhoto.com | kadmy
The United Kingdom (UK) left the European Union (EU) on 31st January 2020, and was in 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) onto the market in Great Britain (GB – consisting of England, Scotland and Wales). The European Union PPE Regulation (EU) 2016/425 was brought into UK law to become ‘Regulation 2016/425 on personal protective equipment, as amended to apply in GB’. This required the UKCA mark (shown in figure 1) to be affixed as a means of showing conformity with all applicable UK legislation.
Like the EU PPE Regulation, this UK legislation requires a network of Conformity Assessment Bodies (CABs) to carry out certain defined tasks. These CABs are termed ‘Approved Bodies’ by the Regulation and operate in exactly the same way as Notified Bodies in the EU.
Initially, it was required that any PPE to be placed on the GB market after 2021 carry the UKCA mark, albeit with a one-year transition where the UKCA mark could be affixed to the accompanying documentation rather than on the product itself. This gave manufacturers and Approved Bodies one year to get everything certified. However, it quickly became apparent that this was insufficient time, so the deadline was put back by 12 months. Also, during this extended time additional legislative easements were introduced which allowed manufacturers, under certain conditions, to affix a UKCA mark based on an EU type-examination (CE) certificate issued by a Notified Body. The deadline for making the UKCA mark a mandatory requirement was then put back to 2025 with the easement dates adjusted accordingly.
Then finally (and quite unexpectedly) on 1st August 2023, the UK government announced that the CE mark would be accepted ‘indefinitely’ for PPE placed on the GB market. The term ‘indefinitely’ has been criticised as is slightly ambiguous and therefore unhelpful to stakeholders and the industry with regard to making future plans. Further information and detailed guidance are still awaited. Hence, areas such as whether the previously announced easements will still apply and how the ‘indefinite’ approach adopted for PPE will integrate with other UKCA legislation for products such as medical devices where an introduction date is still in place are all unclear. From what we understand, further consultations, both within the UK and internationally, will continue over the coming months and then the text of the statutory instruments will be finalised so that it can be laid before the UK parliament and on the statute books by the end of 2024.
Without sight of detailed text, it is difficult to know what will eventually be required. Therefore, at this stage the safest approach for products being placed on the GB market is probably to just apply the CE mark. If for some reason you want to additionally or alternatively affix a UKCA mark, then we would recommend that you only do this if you have the required certification from a UK Approved Body.
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 test reports 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.
SATRA is world-renowned for its testing and certification services in the field of personal protective equipment. Manufacturers of PPE can certify their products for sale in the European Union by working with SATRA’s Notified Body in Ireland (an EU 27 member state), thus enabling affixation of the CE mark. SATRA is also able to conduct conformity assessment work and issue UKCA certifications from its Approved Body in the UK.
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