Don’t pay lip service to your technical file

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