Technical documentation

Record keeping

You, or your authorised representative (where allowed for in the relevant legislation), must keep documentation to demonstrate that your product conforms with the regulatory requirements. This must be kept for up to 10 years after the product is placed on the market.

This information can be requested at any time by market surveillance or enforcement authorities to check that your product conforms with the statutory requirements.

The information you must keep will vary depending on the specific legislation relevant to your product. You must keep general records of:

·         how the product is designed and manufactured

·         how the product has been shown to conform to the relevant requirements

·         the addresses of the manufacturer and any storage facilities

You should keep the information in the form of a technical file which can be supplied if requested by a market surveillance authority.

UK Declaration of Conformity

The UK Declaration of Conformity is a document which must be drawn up for most products lawfully bearing a UKCA marking. We recommend that manufacturers have a separate UK Declaration of Conformity to their EUDeclaration of Conformity.

In the document you as the manufacturer, or your authorised representative (where allowed for in the relevant legislation), should:

·         declare that the product is in conformity with the relevant statutory requirements applicable to the specific product

·         make sure the document has the name and address of the manufacturer (or your authorised representative) together with information about the product and the conformity assessment body (where relevant)

The UK Declaration of Conformity should be available to market surveillance authorities on request.

The information required on the Declaration of Conformity is largely the same as what was required on an EU Declaration of Conformity. This can vary depending on the application legislation but generally should include:

·         your name and full business address or that of your authorised representative

·         the product’s serial number, model or type identification

·         a statement, stating you take full responsibility for the product’s compliance

·         the details of the approved body which carried out the conformity assessment procedure (if applicable)

·         the relevant legislation with which the product complies

·         your name and signature

·         the date the declaration was issued

·         supplementary information (if applicable)