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CE marking after-Brexit

03 February 2020

Regardless of what happens with the Brexit deal, the actual process for manufacturing compliant products will have little effect from a legal perspective.

As the EU Directives are transposed into National Law, the UK already has a legal system in place that applies. There will of course be text amendments to reflect UK legislative requirements, including the UKCA mark and removal of references to EU directives and the CE marking. While references to ‘harmonised standards’ will change to ‘designated standards’, the actual standards will remain the same as EU harmonised standards, and will be carried across as UK designated standards to maintain a single model.

Post-Brexit, in the United Kingdom end-users will start to see a UKCA mark on compliant products, while those in the EU will still see a CE marking. So, whether United Kingdom or EU the same rules apply for designers, manufacturers and importers – everyone must understand their legal duties and responsibilities. In the UK, procedures will change very little from the existing structure as all products will still need to comply with the essential requirements.

The most significant impact after Brexit will be on the location of the manufacturer. Under CE marking rules, UK companies exporting into the EU would previously have appointed a responsible person that was authorised to compile the technical file, and then the manufacturer could self-declare a product’s compliance. After Brexit, this responsible person or entity must now be physically located in the EU, which is the same rule that has been applied for many years to any other country outside of the EU. This will be reciprocated for EU entities importing into the UK, although the definition wording may be slightly different. Quite simply, post-exit from EU, the UK will operate a separate regulatory regime just like the rest of the world. 

Read the full article in the February issue of DPA.

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