Declaration of Conformity: A guide to DoC services for the EU and UK

This guide explains everything you need to know about Declarations of Conformity: what they must contain, how EU and UK requirements differ, and how to ensure your DoC is compliant. Whether you’re creating your first DoC or reviewing existing declarations, this comprehensive resource will help you navigate the requirements with confidence.

What is a Declaration of Conformity?

A Declaration of Conformity (DoC) is a legal document in which the manufacturer (or their authorised representative) formally declares that a specific product complies with the essential health and safety requirements of relevant EU directives or UK regulations. By signing the DoC, you accept full responsibility and liability for your product’s compliance with applicable legislation.
The DoC is intrinsically linked to CE marking and UKCA marking. You cannot legally affix these marks without a compliant Declaration of Conformity.
The DoC is the final step in the compliance process. Before signing, you must ensure your product genuinely meets all requirements, including risk assessments, testing, technical documentation, and conformity assessment procedures. A compliant DoC, combined with proper CE or UKCA marking, demonstrates to authorities, customers, and end-users that your product meets regulatory standards.

Common misconceptions and correct terminology

Businesses often confuse different terms related to product compliance. Let us clarify the most common errors.

Incorrect: CE Declaration of Conformity or UKCA Declaration of Conformity. The marking is placed on the product itself, not on the declaration. The declaration supports the marking.

Incorrect: EC Declaration of Conformity. Older directives used the term but it’s currently outdated.

Incorrect: Certificate of Conformity. CoC is typically issued by third parties; EU Doc is issued by the manufacturer.

Correct: EU Declaration of Conformity or UK Declaration of Conformity. This is the official and modern term, as the document declares conformity under European Union or United Kingdom law.

The DoC is a claim you make about your own product, based on robust evidence compiled in your technical documentation. It acts as the public-facing summary and pledge of compliance.

Note: For many products, you may need both a notified body certificate (which you reference in your technical file) and your own Declaration of Conformity.

Which is the relationship between the UKCA or CE Marking and the DoC?

The EU declaration of conformity and the UKCA or CE marking are two sides of the same coin, serving distinct but interconnected legal purposes.

  • The UKCA or CE marking: It’s the physical symbol affixed to your product, its data plate, or packaging.
  • The Declaration of Conformity: This is the documentary proof that justifies the marking.

Crucially, the marking is affixed to the product, not printed on the declaration.

When a product bears the UKCA or the CE marking and is supported by a valid EU Doc, UK or EU member states presume the product is compliant, facilitating its free movement

Do I need a DoC?

Many products sold in the EU or UK require a Declaration of Conformity. Specifically, all products that fall within the scope of CE marking or UKCA marking require a DoC (or specific variations like Declaration of Incorporation for partly completed machinery, or Declaration of Performance for construction products).
Products requiring a DoC include:

  • Electrical and electronic equipment – Low Voltage Directive (LVD) (2014/35/EU), Electromagnetic Compatibility Directive (EMC) (2014/30/EU), Restriction of Hazardous Substances Directive (RoHS) (2011/65/EU)
  • Radio equipment – Radio Equipment Directive (RED) (2014/53/EU)
  • Machinery and equipment – Machinery Directive (2006/42/EC) and Machinery Regulation ((EU) 2023/1230)
  • Medical devices – Medical Devices Regulation (MDR) ((EU) 2017/745), In Vitro Diagnostic Regulation (IVDR) ((EU) 2017/746)
  • Personal protective equipment (PPE) – PPE Regulation ((EU) 2016/425)
  • Toys – Toys Safety Directive (2009/48/EC)
  • Pressure equipment – Pressure Equipment Directive (2014/68/EU) and Simple Pressure Vessels Directive (2014/29/EU)
  • Gas appliances – Gas Appliances Regulation ((EU) 2016/426)
  • Construction products – Construction Products Regulation (requires Declaration of Performance) ((EU) No 305/2011)
  • Recreational craft – Recreational craft Directive (2013/53/EU)
  • Measuring instruments – Measuring Instruments Directive (MID) (2014/32/EU) and Non-Automatic Weighing Instruments Directive (2014/31/EU)
  • Outdoor equipment – Noise Emission Directive (2000/14/EC)
  • Explosives – Explosives Directive (2014/28/EU)
  • ATEX equipment – Equipment for use in potentially explosive atmospheres (2014/34/EU)
  • Energy-related products – Ecodesign Regulation ((EU) 2024/1781)

If you are unsure about your specific situation, please don’t hesitate to contact us so that we can get back to you with an explanation for your specific needs:

This list is not exhaustive. To determine if your product needs a DoC, check whether it falls within the scope of any EU directive or UK regulation. The scope, definitions, and exceptions are detailed in each specific directive or regulation.
Important note: Under the General Product Safety Regulation (GPSR), which came into force on 13 December 2024, virtually all consumer products sold in the EU must have an EU-based economic operator (manufacturer, importer, authorised representative, or fulfilment service provider) clearly identified. This significantly expands the range of products requiring proper compliance documentation.
If you’re selling directly to end-users online through platforms like Amazon or eBay, marketplace requirements may be stricter than legal minimums. Many platforms actively check for DoCs before allowing product listings.

What must the DoC include?

  • Manufacturer’s name and full address: If you’re not established in the EU/UK, also add your EU or UK Authorised Representative contact details.

  • Product identification: Model, type, batch or other unique identifier.

  • Applicable directives and regulations: List all that apply (e.g., LVD, EMC, RED, GPSR, Machinery Directive; UK equivalents for UK DoC).

  • Applied standards: Include EN/BS EN identifiers and year/edition. List only those standards actually used in your conformity assessment.

  • Notified Body information: (if applicable) Include Notified Body (or UK Approved Body) details if a conformity assessment body was involved.

  • Place and date of issue: Where and when the DoC was signed.

  • Name and function of signatory, plus signature: Wet or digital signature accepted. Ensure the signatory has authority to sign on behalf of the manufacturer.

What is the single declaration principle?

Modern law introduces a practical approach: if a product falls under multiple directives requiring a declaration, they must be shown in a single, consolidated Declaration of Conformity. This document must:

  • Clearly identify all applicable acts.
  • Provide a compliance overview.
  • Simplify documentation for market surveillance authorities.

EU vs UK: key differences

Aspect EU (CE marking) UK (UKCA marking)
Marking CE for EU/EEA market UKCA for Great Britain; CE/UKNI for Northern Ireland
Standards EN harmonised standards, and any other technical specifications/standards UK designated standards, and any other technical specifications/standards
Contact point EU Authorised Representative required for non-EU manufacturers UK Authorised Representative required for non-UK manufacturers
Legal references EU directives and regulations (e.g., 2014/35/EU) GB statutory instruments (e.g., SI 2016/1091)
Language Must be translated to language(s) of destination country English acceptable throughout UK

How to create a DoC (5 steps)

Step 1: Identify applicable regulations and directives

Determine which EU directives or UK regulations apply to your product based on its characteristics and intended use. Many products fall under multiple directives (e.g., electronics typically need LVD + EMC + RoHS).

Step 2: Compile applicable harmonised standards

Identify the harmonised standards you’ve used to demonstrate conformity. Check the EU Official Journal for harmonised standards (or gov.uk for UK designated standards) for current standards lists. Include full references with years (e.g., EN 60950-1:2006+A2:2013). Only list standards you’ve actually tested against.

Step 3: Fill in the DoC template

Complete all required fields:

  • Manufacturer details and address
  • EU AR or UK AR contact details (if applicable)
  • Product identification with model numbers
  • All applicable directives/regulations
  • All applied standards with full references
  • Notified Body information (if used)

Step 4: Sign the declaration

The DoC must be signed by someone with legal authority to bind the manufacturer (director, authorised person, or your AR/RP if mandated). Include name, title, date, and location.

Step 5: Store and make available

Keep the DoC for at least 10 years as part of your technical file. Provide to authorities, customs, or marketplace platforms upon request. Review annually and update when regulations, standards, or product design changes.

Common mistakes to avoid

  • Using the wrong or incomplete address (missing EU/UK AR for non-EU/UK manufacturers)
  • Incorrect standard citations (missing amendment year or using withdrawn editions)
  • Mixing up Certificate of Conformity (from a lab) with the Declaration of Conformity (from the manufacturer)
  • Unsigned or undated documents
  • One DoC covering unrelated models with different compliance footprints
  • Copy-pasting legal text that doesn’t match your product’s actual assessment route
  • Mixing up EU and UK requirements
  • Not updating DoC when regulations change
  • Forgetting to translate the DoC
International shipping container ship

What happens if you don’t have a compliant DoC?

  • Customs holds and inspections leading to delays and storage/demurrage costs.

  • Administrative fines and post-clearance reassessments of duty/VAT.

  • Seizure, re-export, or destruction of non-compliant goods in serious cases.

  • Supply-chain disruption (brokers/refused entries) and marketplace account issues.

  • Follow-up audits requiring full documentation and proof of declarations.

Conclusion

A clear, accurate DoC helps you place products on the market with confidence and avoid unnecessary delays with authorities, distributors, and marketplaces. Whether you’re creating your first EU declaration of conformity or updating existing UKCA declarations, having a properly formatted DoC template and understanding the requirements ensures smooth market access.

Ferry Vermeulen CO-Founder 24hour-AR

Author Ferry Vermeulen is the Co-Founder of 24hour-AR, a company dedicated to providing authorised representative services as well as CE marking services. With a background in industrial design engineering, Ferry specialises in facilitating swift compliance with EU regulations, enabling manufacturers to enter markets seamlessly.

Frequently asked questions

Where should I store my Declaration of Conformity?2025-11-25T13:50:14+00:00

Store the DoC as part of your technical file in a secure, accessible location. Some directives require the DoC to physically accompany the product. You must be able to provide it immediately to authorities, customs, or marketplace platforms upon request.

Do I need a Declaration of Conformity for components or only for finished products?2025-11-25T13:49:51+00:00

Typically only finished products require a DoC. However, partly completed machinery requires a Declaration of Incorporation instead. DoCs of components support the main product’s technical file.

Can a Declaration of Conformity be digital or must they be printed?2025-11-25T13:49:15+00:00

Both digital and printed DoCs are legally acceptable. Digital signatures are permitted if they meet legal requirements. Ensure you can provide the DoC immediately when requested by authorities, customs, or marketplace platforms.

Does the Declaration of Conformity need a Notified Body number?2025-11-25T13:48:04+00:00

Only if your product requires third-party conformity assessment. Many products can be self-certified without Notified Body involvement. If a Notified Body was involved, you must include their name, identification number, and certificate reference on the DoC.

Can my Authorised Representative hold or draft the Declaration of Conformity?2025-11-25T13:46:22+00:00

Yes. Your EU or UK Authorised Representative can hold the DoC, draft it on your behalf, and sign it if explicitly authorised in your mandate agreement. However, the manufacturer remains ultimately responsible for its accuracy.

In which languages must the Declaration of Conformity be provided?2025-11-25T13:45:40+00:00

For EU: The DoC must be translated into the language(s) of the country where the product is sold. For UK: English is acceptable. Some directives have specific language requirements, so check your applicable regulations.

What’s the difference between a Declaration of Conformity and a Certificate of Conformity?2025-11-25T13:44:15+00:00

The Declaration of Conformity is mandatory and issued by the manufacturer (or authorised representative), while a Certificate of Conformity is additional evidence issued by a third party and does not replace the DoC.

Does a Declaration of Conformity expire?2025-11-25T13:44:03+00:00

No, DoCs don’t expire, but they must be updated when regulations change, standards are revised, product design changes, or your Authorised Representative changes. Review annually to ensure it remains current.

Can I use one Declaration of Conformity for multiple product variants?2025-11-25T13:41:53+00:00

Yes, if the variants share the same compliance characteristics, use the same standards, and comply with the same directives. All model numbers must be clearly identified on the DoC.

Who can sign a Declaration of Conformity?2025-11-25T14:55:18+00:00

The DoC must be signed by someone with legal authority to bind the manufacturer—typically a company director or authorised officer. Your EU or UK Authorised Representative can also sign if explicitly authorised in your mandate agreement.

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