Overview
If you manufacture, import, or sell
regulated products in the EU or UK, you have likely come across the term
“Declaration of Conformity”. This article explains what it is, when you need
one, and exactly what it should contain.
A Declaration of Conformity (DoC) is
a legal document in which the manufacturer — or their authorised representative
— formally declares that a specific product meets the health and safety
requirements set out in relevant EU or UK legislation.
Think of it as a signed promise that
states:
“We,
the manufacturer, confirm this product is safe and complies with all
applicable legal standards required to be sold in this market.” By signing a DoC, the
manufacturer accepts full legal responsibility for the product’s compliance.
It is directly linked to the CE mark (EU) and UKCA mark (UK) — you cannot
lawfully affix either mark without a valid DoC to support it. |
A DoC is required for any product
that falls within the scope of CE or UKCA marking regulations. Common product
categories include:
• Electrical and electronic equipment
• Radio and wireless devices
• Machinery and industrial equipment
• Personal protective equipment (PPE)
• Medical devices and diagnostics
• Toys and children’s products
• Construction products (with some variations)
To Note: if your
product requires a CE mark or UKCA mark, it almost certainly requires a DoC to
accompany it.
EU vs UK — what’s the difference?
Since Brexit, the EU and UK operate
two separate but closely related systems. Here is what you need to know:
EU (CE Marking) | UK / Great Britain (UKCA Marking) |
Based on EU directives and harmonised standards | Based on UK legislation and UK designated standards |
Required for selling in EU/EEA member states | Required for selling in England, Scotland, and Wales |
Notified Bodies handle third-party assessment | UK Approved Bodies (accredited by UKAS) handle third-party
assessment |
Good
news for most sellers: Under the Product Safety and
Metrology (Amendment) Regulations 2024, Great Britain now recognises CE
marking indefinitely for most product categories. This means many businesses
can use a single CE-marked product and EU DoC to sell in both the EU and Great
Britain — reducing duplication. However, some higher-risk categories (such as
medical devices and construction products) still require a UK-specific DoC.
Always check which route applies to your product.
|
The exact content required will
depend on the specific legislation that applies to your product. However, most
DoCs — whether EU or UK — must contain the following nine elements:
# | What to
include | Plain
English explanation |
1 | Product
identification | Product name,
model number, and serial or batch number |
2 | Manufacturer
details | Full legal name
and business address of the responsible company |
3 | Authorised
representative | If you sell via
a representative in the EU or UK, their full details must be listed |
4 | Applicable
legislation | The specific EU
directives or UK regulations the product has been assessed against |
5 | Standards
applied | The technical
standards used during testing to confirm compliance (e.g. EN/BS EN
references) |
6 | Notified/Approved
Body | If a
third-party testing body was involved, include their name and official ID
number |
7 | Statement of
conformity | A clear written
declaration that the product meets all relevant legal requirements |
8 | Date and place
of issue | Where and when
the document was signed |
9 | Authorised
signature | Name, job
title, and signature of a person authorised to sign on behalf of the
manufacturer |
Important
— consistency is key: The details in your DoC must
match your product labels, packaging, and test reports exactly. If the model
number, batch number, or manufacturer name differs between documents, this
could be flagged by market surveillance authorities and may result in your
product being deemed non-compliant.
|
Why does it matter?
The DoC is more than a formality. It
is the legal foundation of your product’s compliance. Here is why it matters:
• It confirms your product has been assessed and meets
legal safety requirements
• It is required before you can apply a CE or UKCA mark
• Authorities can request it at any time — failure to
produce a valid DoC can result in fines or a product recall
• Online marketplaces such as Amazon and eBay may require
a DoC before allowing product listings
• It protects both your business and your customers
Frequently asked questions
Who is responsible for creating the DoC?
The manufacturer is responsible —
but “manufacturer” has a broad meaning in law. It includes the company that
owns the design or brand, even if a third-party factory physically produces the
goods.
How long should I keep it?
You should retain your DoC (and
supporting technical documentation) for a minimum of 10 years from the date the
product was last placed on the market. Some product categories require longer
retention periods.
Can one DoC cover multiple products?
Generally, you need a separate DoC
for each product model. However, minor variations of the same model (such as
different colours) can often be covered within a single document, provided the
applicable legislation and standards are identical across all variants.
Do I need a DoC for Northern Ireland?
Yes. Northern Ireland continues to
follow EU regulations under the Windsor Framework, so products sold there
typically require CE marking and an EU DoC, rather than UKCA.
Need more help?
If you require additional information, no problem. Contact Us and our
Compliance Team will be happy to help.