UKCA Compliance Part 2 – Contents of Technical Files

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With the Transition period ending in 2021, the required content of product Technical Files will change.

The advice here is for GB and not the UK as a whole.

For most regulated products, from the end of 2020, the GB market will for a period accept either UKCA or CE marking. Many CE marked products will be allowed until the end of 2021.

What changes are there for Technical Files?

There are only a few different areas. A single Technical File can be used for both. No need for 2 separate files. Where different information is needed, simple statements within a common Technical File can state the differences.

So, what are the differences required?

Copies of signed Declarations of Conformity need to be in the Technical File. These are legal statements. There are differences in content between GB and EU requirements. 2 separate declarations, one for CE and one for UKCA need to be in the combined File.

For UKCA manufacturer’s Declaration and Instructions should be in English, whereas for CE they should be in the appropriate European language.

The File should include copies of Declarations for third party parts. For UKCA until the end of 2021 third party declarations can be either UKCA or CE declarations. However, for CE marking they should be CE ones.

Details of and test results for design safety standards should exist. List them and provide proof of tests or compliance. For CE these are normally ‘harmonised standards’ and should be noted as EN standards with no national prefix.

For UKCA, the GB system will be based on ‘UK Designated standards’. Standards will, however, need to be British Standards, so the Technical File and the Declaration of Conformity for the UKCA mark would use the British national BS pre-fix, for example, BS EN ISO 13857 for guarding.

All the other required information in the Technical File is common to both marking systems.

For any more information relating to UKCA compliance, please don’t hesitate to contact [email protected]