European Regulation: CE Marking

CE marking is required on products which are traded on the extended European Economic Area (EEA) single market, which includes all EU countries alongside Iceland, Liechtenstein and Norway and non-EEA country Switzerland. Whilst CE marking is a European legislation, this does not certify that a product was manufactured in the EEA, but rather that the product was assessed prior to European market entry.

CE marking applies to a wide range of products, including machinery, measuring instruments, pressure equipment, active implantable and in vitro medical devices and personal protective equipment, but does not apply to items such as chemicals, pharmaceuticals, cosmetics or foods. By affixing the letters “CE” on a product, this declares the conformity of that product to be sold in the EEA in alignment with European health, safety and environmental protection standards. It is typically the product makers responsibility to obtain this CE marking. Products can hold a CE marking even if they are manufactured in another country, so long as they are sold in the EEA. CE marking also supports fair market competition, through ensuring all companies are accountable to the same rules. In accordance with the current guidelines, companies should obtain CE marking if goods will enter the EEA market up to 1st January 2023.

In addition to confirming that a product aligns with EEA safety standards, CE marking allows the free movement of products on the European market, in addition to ensuring a product is compliant with EU legislation. There are also several benefits to companies that a CE marking can bring. One is that businesses know that a CE marking confirms a products ability to be traded in the EEA single market without restriction. Another benefit is that purchasers of the product are guaranteed the same level of health, safety and environmental protection across the entire EEA.

CE marking allows for European legislation to be harmonised across several countries. This alignment is managed by the Directorate-General for the European Internal market, Industry, Entrepreneurship and SMEs, whilst CE marking for the Restriction of Hazardous Substances is managed by the Environmental Directorate-General. The European Blue Guide document provides comprehensive guidance of the implementation of EU CE marking product rules.

Written by:
Anna Cranston

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