Overall, CE and UKCA marking is a four-stage process:
- Conformity assessment – meeting the ‘essential requirements’, choosing standards, and possibly testing.
- Documentation – this includes the creation of the Declaration of Conformity (DoC) and technical file.
- Labelling – CE or UKCA marking and the manufacturer’s details.
- Agreement of Economic Operator Responsibilities – the term ‘economic operator’ means either the manufacturer, importer, authorised representative, or 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. Yet this is arguably the most important element since it proves due diligence and evidence of compliance, should market surveillance authorities, such as Trading Standards, identify a problem with a product.
In the UK, other examples of market surveillance authorities include the Health and Safety Executive (HSE) for machinery, pressure vessels, ATEX, etc; the Medicines and Healthcare products Regulatory Agency (MRHA); and the Office of Communications (Ofcom) for the protection and management of the radio spectrum.
It is important to note that due diligence is defined within legal precedent. This means that you cannot simply take someone else’s word as evidence, and you must prove it as much as possible. One example would be receiving a photocopy DoC from a parts provider and nothing else. However, this would probably not be sufficient to support the conformity assessment of the end product.
What is a technical file?
One of the most often asked questions of TÜV SÜD’s advisory services is regarding the contents of the technical file. A technical file is documented evidence to show that the product properly complies with the ‘essential requirements’ of the Directive(s) or Regulation(s) which apply to the product.
A good starting point is the EU’s ‘Blue Guide’ on the implementation of product rules which outlines the type of documents that surveillance authorities would expect to find in a technical file. The manufacturer must establish the technical documentation that shows how the ‘essential requirements’ of the relevant Directive(s) or Regulation(s) have been met.
A good technical file must cover the design, manufacture and operation of products and could include:
- ISO / quality documents
- Physical construction / CAD drawings
- Risk assessment (if applicable)
- Test reports (if applicable)
- DoC
- Label exhibits
- Internal / external photos
- User manual
- Parts lists
- Block diagram
- Operational description
- Schematics
The technical file provides vital evidence that the correct procedures have been taken during product development and manufacturers must be prepared to show it to market surveillance authorities upon request. For CE marking, enforcement authorities are also entitled to demand the technical file be provided in any official EU language, so be prepared to translate it.
The technical file can be a traditional paper file, or stored electronically, with hyperlinks to documents. It must also be kept up to date as the product is adapted, which means that it cannot be put away and forgotten, and it must also be retained for ten years.
Those that bring goods into GB for the first time (importers), have obligations to check the conformity assessment approach. This includes the DoC and technical file. However, it may be that the manufacturer has sensitive information within the technical files that they do not wish to share (typically the last four points listed above). This is perfectly acceptable, as the only party that must be provided with this information is the market surveillance authority.
Likewise, anyone re-branding a product takes on the full responsibilities of the manufacturer. This includes signing the DoC, labelling with their details, and keeping the technical file on record.
Trading Standards may also spot-check goods entering the UK, as importers are required to hold evidence of the test reports and certificates to prove compliance in the form of the technical file. If such information is missing, this may result in their prosecution as they have a legal responsibility for ensuring proof of compliance. Without it, the manufacturer, importer or retailer could face significant fines or even imprisonment.
About TÜV SÜD www.tuvsud.com/uk
TÜV SÜD is one of the world’s leading experts in product testing and certification, with 150,000 product certificates in circulation globally. Its Product Service division analyses over 20,000 products each year in Europe, Asia-Pacific and the Americas, using its technical expertise to help customers optimise market access.
TÜV SÜD’s Machinery Safety Division is the UK market leader in machinery safety, providing a range of services on a world-wide basis. It is also the official partner of the Process and Packaging Machinery Association on regulatory affairs.
TÜV SÜD BABT is the world’s leading radio and telecommunications certification body with EU based Notified Bodies and UK Conformity Assessment Body status. This enables TÜV SÜD to satisfy both CE and UKCA requirements for multiple EU Directives and UK Regulations, including those for radio equipment, machinery and electromagnetic compatibility, along with Wheel Mark and UK Conformity Mark requirements for marine equipment.