Manufacturers and importers require CE marking (European Union) or UKCA marking (Great Britain) before they can supply or use certain types of equipment and products.
The Manufacturer’s Declaration of Conformity (DoC) is central to the CE and UKCA certification process. This document demonstrates that equipment meets the legal and safety requirements in the European and UK markets.
A Declaration of Conformity is a statement from the manufacturer or importer that their equipment complies with relevant legislation.
For CE marking and UKCA marking, the Declaration of Conformity defines the relevant directives and standards to which the product conforms. It shows that equipment has been assessed and meets essential health, safety, and environmental requirements.
As a manufacturer, you can issue the DoC yourself, or it can be issued by a representative economic operator of the goods. This will depend on the applied directive or standards.
A copy of the manufacturer’s declaration will usually be supplied with the equipment or product. The document often accompanies equipment as part of the equipment manual.
A Declaration of Conformity is required for most equipment and products that fall under CE or UKCA marking regulations. This may include manufacturing equipment and machinery, as well as products such as electronics and medical devices.
The DoC must be completed before placing the product on the market and kept up to date if there are changes to the equipment or applicable legislation. The responsibility for drafting and signing the DoC lies with the manufacturer or their authorised representative.
The following essential components make up a Declaration of Conformity:
Full name and address of the manufacturer or authorised representative.
Clear identification of the product, including trade name, model number, type, and serial number or identification tag if applicable.
A declaration that the product complies with the relevant legislation (e.g. EU directives or UK regulations).
A list of the directives, regulations, or statutory instruments that apply to the product.
Details of the specific harmonised (EU) or designated (UK) standards used to demonstrate conformity.
The name and details of any conformity assessment body involved, along with its role.
When and where the declaration was signed.
Name, position, and signature of the person authorised to sign on behalf of the manufacturer.
Failure to provide a correct and complete Declaration of Conformity can have serious consequences.
You may have legal penalties imposed on your company, such as fines or prosecution. Your equipment could be recalled or banned from the market. And you may find that your organisation has suffered from reputational damage, which leads to a loss of trust from customers or business partners.
Authorities in both the EU and the UK regularly audit and inspect technical documentation. Therefore, a missing or incorrect DoC can lead to immediate enforcement action.
A Declaration of Conformity must be kept for at least 10 years after the last unit of the product has been placed on the market. It must be made available to:
A well-maintained manufacturer’s declaration is part of a broader Technical File required for CE and UKCA marking certification, and should be easily retrievable.
The Declaration of Conformity must be available in the official language(s) of the country where the product is being sold.
For example, if the product is placed on the German market, the DoC must be in German. Failure to provide a correctly translated DoC may render it invalid in that jurisdiction.
We recommend using a clear, standard format for your Declaration of Conformity. You should regularly review applicable legislation and update the DoC as needed.
It is important that the responsible person understands the legal significance of their signature, including personal accountability and legal responsibility, as well as that the signature binds the company or organisation which they represent.
Keeping a master template can help ensure consistency across different equipment and products.
In order to navigate CE and UKCA compliance with ease, you need expert support to guide you through every step of preparing your Declaration of Conformity.
From identifying applicable regulations to reviewing technical documentation including a DoC, IES gives you peace of mind at every step to CE and UKCA certification.
Contact IES today and discover how we can help you meet compliance obligations with confidence