PPE Certification after Brexit

The European Union has stopped recognising CE (Certificates, EU) marks issued by United Kingdom Notified Bodies since January 1, 2021. After being translated and amended into UK law in 2016, European PPE EU regulation 2016/425 has now become effective both in the UK and the EU.

PPE can be legally sold in the UK market only if it is first assessed and certified by a UK Approved Body to ensure compliance with the requirements of the PPE Regulation 2016/425, which then is affixed with a UKCA mark. This was the only viable way to ensure UKCA compliance in the original policy measures.

In an effort to make the transition as easy as possible for businesses, the Department of Business, Energy and Industrial Strategy (BEIS) has announced new transitional easement measures for the UKCA mark. These measures are designed to take a pragmatic approach to implementing the UKCA mark. Until EU Type Examination certificates expire (by 31st December 2027), they can be used as a basis for UKCA marking. After 1st January 2025, the goods must still carry the UKCA marking.

The manufacturer can apply the UKCA marking, and the UK importer details via a sticky label onto the product packaging or via an accompanying document (i.e., IFU (Instructions for Use)) until 31st December 2027. Following December 31, 2027, the UKCA marking must be printed directly on the packaging or product itself.

PPE must be dual certified and therefore dual marked with CE and UKCA marks as of 1st January 2025 in order to legally be sold in the European Union and the UK.