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Don’t pay lip service to your technical file

06 January 2023

The UKCA (United Kingdom Conformity Assessment) mark will be required for most products placed on the market in England, Scotland and Wales (GB) from 1 January 2025. At present, UKCA requirements align well with CE marking, but over time, divergence is possible.

(Image: Shutterstock)
(Image: Shutterstock)

There is currently a transition period until 31 December 2024, where UKCA is optional (suggested) and CE marking is accepted. Particular rules are in place for certain legislative areas, such as medical, marine, and construction products.

Overall, CE and UKCA marking are both a four-stage process:

1) Conformity assessment – meeting the ‘essential requirements’, choosing standards, possibly testing
2) Documentation – this includes the creation of the Declaration of Conformity (DoC) and a technical file
3) Labelling – CE or UKCA marking and the manufacturer’s details.
4) Agreement of Economic Operator Responsibilities – the term ‘economic operator’ means either the manufacturer, importer, authorised representative, or the distributor

The affixing of the CE or UKCA marking to a product indicates that the manufacturer has performed an adequate conformity assessment and that the product meets the ‘essential requirements’ of a given regulation, such as the Electromagnetic Compatibility or Low-Voltage (safety) Directives. This is supported by the DoC, which must be signed by a responsible person within the organisation. 

Most of this is already well-known, but one aspect commonly overlooked is the technical file...


Read the full article in DPA's January issue



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