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CE or UKCA Marking: Observations on Technical Files

CE or UKCA Marking: Observations on Technical Files

If you are a manufacturer or an ‘importer’ (see note 1 below) of a UKCA or CE marked product into Great Britain, then you need to hold a Technical File (TF). The legal requirements frequently require the TF to be available for up to ten years after the last product has been sold or put on the market. Many TFs are insufficient so what makes a good technical file?

Posted

16.05.2025

Written by

Howard Wheeler

Often, such a product falls under more than one product marking regulation, for example, Supply of Machinery (Safety) Regulations and Electromagnetic Compatibility Regulations or Electrical Equipment (Safety) Regulations and Electromagnetic Compatibility Regulations. Regulations typically forgotten about include the RoHS regulations, the Radio Equipment Regulations and Ecodesign Regulations, but not all products fall under these.

It is important you know what the relevant regulations are and what each requires in the T.F. Luckily, many regulations, at least in part, require similar common content, but each has some specifics that need to be fulfilled.

It makes sense to have one combined TF for a product covering all of the regulations, but nothing stops you from having different TFs for each regulation. A TF can cover a product range or a set of similar products, so you don’t necessarily need separate ones for each model. As each product needs a Declaration of Conformity or Declaration of Incorporation (see note 2), a good rule of thumb is that if the declaration applies to several products (see note 3), then there can be a common TF.

Perhaps the most important aspect to remember is that the TF is your defence to prove a safe (to people and environment) product.

You need to make sure it is complete and correct. This is your responsibility, and although only a manufacturer can assemble the TF, an Importer must check that all is fine. For many Importers, this is easier said than done, as knowledge of what is required is often lacking.

Importers assume this responsibility as non-UK manufacturers do not necessarily fall under UK jurisdiction. For non-UK-manufactured products, the Importer is frequently the only body the UK can take to task. This is their responsibility. Even if there is a legal agreement between the two parties for the TF to be provided on requirement, if in practice this doesn’t occur, the Importer ‘takes the wrap’! Manufacturers can cease to exist or end up not meeting their commercial obligations. Remember, this is a ten-year obligation, and a lot can happen in a decade.

It is common for manufacturers to not release the TF. In this case the ONLY option is for the manufacturer to set up a UK based Authorised Representative (AR) to act on their behalf.

A UK AR falls under UK jurisdiction and would have to provide the TF on request. As long as the Importer can be certain there is a UK AR whilst ever they sell the product, then they can relax!

Going back to the content, a good approach is to treat the TF as a product story book complete with sections, chapters or folders, configured so it takes the reader down a logical path. This identifies what the product is, lists the regulations covered, provides drawings (with explanations if needed), bill of materials, list of applicable essential health and safety requirements for machinery (note 4), different risk assessments for each of the regulations where they need one, lists of the designated standards used and copies of their test/verification/validation results, copies of 3rd party Declarations, 3rd party Instruction books/data sheets/instructions, the overall manufacturer’s  Instruction book (note 5) and finally the signed Declaration of Conformity.

To do the above, it is best to have a logical structure with named sub-sections or folders containing the relevant information, a high-level coordination document should be included so the reader can easily follow the case being made. Remember, the TF is constructed for the relevant Authorities who legally enforce the regulations. Such a reader is unlikely to have detailed knowledge of your product and will expect the TF to provide that knowledge.

If the product is for the UK, all information in the TF must be in English.

Test results from 3rd party test houses can often be in their native language. A TF must be provided to the relevant Authorities (on reasoned request) within a reasonable period, although such a time is undefined. If a technical translation can be guaranteed very quickly, then it may be acceptable to have a non-translated version available on the shelf in case it is ever requested. If translations are required, expect the Authorities to also require the non-translated version as well.

Maximum fines for non-supply of TFs depend on whether they are imposed by the Magistrates Court or the Crown Court. The worst case being an unlimited fine and/or up to two years imprisonment (Crown Court). Hence, penalties can be very harsh.

Notes

  1. An ‘importer’ is defined as a body that imports and resells a product. Just importing and using does not make you an importer under the product marking regulations.
  2. Declarations of Incorporation ONLY ever applies to partly completed machinery under the Supply of Machinery (Safety) Regulations and does not satisfy any other product regulation.
  3. Declarations are legal statements, and everything within them must be legally correct for the product(s) they refer to.
  4. The Supply of Machinery (Safety) Regulations require the applicable EHSRs listing. Finch recommends that those not applicable be identified as such in the same list.
  5. The main Instruction Book should be from the manufacturer listed on the overall Declaration of Conformity. In some instances, it can heavily rely on 3rd party information, where appropriate, and if so, identify them in the main Instruction Book along with stating how the whole product is tied together and where to find the various information required by the regulations. If so, the overall manufacturer needs an overseeing Instruction book.

Written by

Howard Wheeler | Finch Consulting

Howard Wheeler

Fellow Consultant

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