EU Declaration of Conformity (DoC) Requirements Under GPSR
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Introduction
For any product entering the EU market under CE marking or falling under the General Product Safety Regulation (EU) 2023/988 (GPSR), the Declaration of Conformity (DoC) is a core legal requirement. This document is a formal, legally binding assurance from the manufacturer that the product meets all applicable EU legislation.
1. What Is an EU Declaration of Conformity?
The EU Declaration of Conformity is a document in which the manufacturer (or their authorised representative in the EU) declares that a product complies with relevant EU legislation. This may include:
- General Product Safety Regulation (EU) 2023/988
- Low Voltage Directive, EMC Directive, Toy Safety Directive
- REACH (Regulation (EC) No 1907/2006)
- RoHS (Directive 2011/65/EU)
- Machinery Regulation (EU) 2023/1230
The Declaration must be supported by appropriate technical documentation and a conformity assessment.
2. Who Must Issue the Declaration?
The manufacturer is responsible for issuing and signing the DoC. If the manufacturer is located outside the EU, they must appoint an EU Authorised Representative. Importers and distributors must ensure the existence and availability of the DoC before placing products on the market.
3. Which Products Require a Declaration of Conformity?
A DoC is required for:
- CE-marked products (e.g. electronics, toys, PPE, medical devices)
- Non-CE products subject to the General Product Safety Regulation
- Products under harmonised legislation that require conformity assessment
One consolidated DoC can cover multiple applicable directives or regulations.
4. What Information Must the DoC Contain?
The Declaration must include:
- Product identification: model, SKU, serial number
- Manufacturer and, if applicable, authorised representative details
- Legally required statement of responsibility
- Product description
- Applicable EU legislation
- Harmonised standards applied
- Notified Body information (if applicable)
- Signature of authorised person with name, date, and role
Example Format:
EU DECLARATION OF CONFORMITY
1. Product: [Description, Model, SKU]
2. Manufacturer: [Name, Address]
3. Authorised Representative: [Name, Address]
4. This declaration is issued under the sole responsibility of the manufacturer.
5. The object of the declaration described above is in conformity with the following legislation:
- Regulation (EU) 2023/988
- Directive 2011/65/EU (RoHS)
6. Conformity has been assessed using the following standards:
- EN 71-1:2014+A1:2018
- EN IEC 62368-1:2020+A11:2020
7. Notified Body: [If applicable]
8. Signature: [Name, Function, Place, Date, Signature]
5. Storage, Language, and Availability
- Retention: Keep the DoC and technical documentation for 10 years after market placement
- Language: Use an official EU language and translate if required by national authorities
- Availability: Provide the DoC to market surveillance authorities on request; some sectors require a copy with the product
6. Supporting Documentation: The Technical File
The DoC must be supported by a technical file that includes:
- Design and manufacturing information
- Risk assessments and relevant test reports
- Instructions, labeling, and SDS (where applicable)
- Declarations from suppliers for components or materials
7. Penalties for Non-Compliance
Failure to issue or maintain a valid Declaration of Conformity can result in:
- Customs seizure or shipment delays
- Product bans or recalls
- Market surveillance actions
- Legal and financial penalties
How GPSR Solutions Helps
GPSR Solutions provides expert support to prepare valid Declarations of Conformity and technical documentation files. We can also act as your EU Authorised Representative, helping ensure your products meet EU market requirements at every stage.