Regulatory Compliance Glossary

The EU Declaration of Conformity is a formal document signed by the manufacturer stating that a product complies with relevant EU legislation. It must reference applicable directives or regulations and harmonised standards where used. The declaration forms part of the product’s compliance documentation.

A conformity assessment procedure is the process of demonstrating that a product complies with applicable regulatory requirements. It may include risk assessment, testing, technical documentation, and, where required, certification by a Notified or Approved Body. The required procedure depends on the product category and risk classification.

UKCA (UK Conformity Assessed) marking is the UK’s conformity mark for products placed on the Great Britain market. It replaced CE marking in certain sectors following Brexit. Manufacturers must comply with applicable UK legislation and complete the required conformity assessment before applying the UKCA mark.

CE marking is a conformity mark showing that a product meets applicable EU safety, health, and environmental protection requirements and can be placed on the European Economic Area (EEA) market. By affixing the CE mark, the manufacturer declares compliance with the relevant EU legislation.