GPSR Technical File Documentation Guide

For GPSR compliance, manufacturers must maintain technical documentation for every product placed on the EU market that falls within the scope of Regulation (EU) 2023/988. This technical documentation (often referred to as the technical file) must contain sufficient information to demonstrate that the product is safe. Depending on the product and its risks, this typically includes a risk assessment, product specifications, Safety Data Sheets (SDS) where relevant, test reports, labeling and user instructions, and, where required by applicable EU harmonisation legislation, an EU Declaration of Conformity.

The GPSR technical file should not be confused with the Digital Product Passport (DPP). The DPP is a separate regulatory framework introduced primarily through the Ecodesign for Sustainable Products Regulation (EU) 2024/1781 and other product-specific EU legislation. DPP requirements will apply progressively to product groups where specific EU rules require them.

Content Overview of General Products’ Technical Documentation

For GPSR compliance, manufacturers must prepare technical documentation before placing products on the EU market. Importers must verify that the manufacturer has prepared the required documentation. The technical documentation should contain sufficient information to assess and demonstrate whether the product is considered safe according to the GPSR.

The level of detail should be proportionate to the complexity of the product and the risks associated with it. A simple low-risk consumer product may require considerably less documentation than an electrical, connected, mechanical, or otherwise higher-risk product.

A complete technical file should include:

1) Product Identification

Labels, packaging artwork, and, where applicable, user instructions/manuals.
Product name, model name/number, type, batch or serial identification, variants, SKU mapping, and high-quality product photos or diagrams.
Information allowing the product to be clearly distinguished from other models and variants.

2) General Description & Specifications

Essential characteristics, technical specifications, intended use, operating conditions, and reasonably foreseeable misuse.
Materials list or a full Bill of Materials (BOM), where relevant to the safety assessment.
Information on components, substances, coatings, batteries, electrical parts, software, or other characteristics that may influence product safety.

3) Risk Assessment & Safety Measures

Documented Risk Assessment covering the hazards associated with normal use and reasonably foreseeable misuse.
Identification of relevant hazards, affected users, possible injuries, risk levels, and the measures used to eliminate or mitigate those risks.
Risk controls, including inherently safe design measures, protective measures, safety warnings, user instructions, and compliant labeling.
Supporting evidence such as relevant test reports, supplier declarations, certificates, specifications, and Safety Data Sheets where applicable.

4) Standards & Compliance References

List of applicable EU legislation and relevant European standards or other technical specifications used to demonstrate product safety.
Where standards have only been applied partially, identification of the applicable clauses or parts used.
Where relevant, references to national standards, international standards, industry safety specifications, scientific guidance, or other evidence used as part of the safety assessment.
Any existing EU Declarations of Conformity required under applicable sector-specific EU legislation.

5) Testing & Certifications

Overview of testing performed, such as chemical, mechanical, physical, flammability, electrical, EMC, radio, food-contact, or other relevant testing.
Details of applicable test methods, standards, laboratories, report numbers, samples tested, and test dates.
Third-party certification reports, supplier documentation, or internal verification records demonstrating conformity.
Where laboratory testing is required or appropriate, evidence should be sufficiently reliable for the applicable regulatory requirement. Accredited laboratory testing may be required under specific legislation, standards, conformity-assessment procedures, contractual requirements, or by market-surveillance authorities.

6) Traceability & Market Responsibility

Manufacturer name, postal address, electronic address, and other required contact information.
Importer details where an importer is involved.
For manufacturers established outside the EU, details of the EU economic operator acting as the Responsible Person under Article 16 of the GPSR.
Supply-chain and batch traceability records, including supplier details, purchase orders, batch/lot logs, manufacturing information, and distribution records where appropriate.
Where applicable, obligations relating to WEEE, batteries, and packaging and EPR compliance.
Product-safety procedures for notifying authorities through the EU Safety Business Gateway where a product is found to be dangerous or where other notification obligations under the GPSR are triggered.

7) Ongoing Compliance Documentation

Quality procedures covering incoming checks, production controls, sampling, final inspection, and non-conformance handling.
Procedures ensuring that products manufactured in series continue to conform to applicable safety requirements.
Design change history and assessments showing whether modifications affect the original safety assessment or applicable compliance requirements.
Consumer complaints, safety incidents, corrective actions, and recall records where applicable.
Records demonstrating that the technical documentation remains current throughout the product lifecycle.
Preparation for obligations and potential exposure under the Product Liability Directive (EU) 2024/2853.

Under the GPSR, manufacturers must keep the technical documentation at the disposal of market-surveillance authorities for at least 10 years after the product has been placed on the market.

Digital Product Passport (DPP)

The Digital Product Passport should be treated separately from GPSR technical documentation. A DPP is a structured digital record containing product-specific information that can be accessed through a data carrier such as a QR code or another machine-readable identifier.

The main framework is Regulation (EU) 2024/1781, the Ecodesign for Sustainable Products Regulation (ESPR). However, the ESPR does not mean that every general consumer product must already have a DPP. DPP obligations become mandatory for individual product groups when the applicable EU legislation or product-specific delegated act introduces them.

The information contained in a DPP may include, depending on the applicable legislation:

Product and manufacturer identification.
Materials and composition information.
Environmental and sustainability information.
Durability, repairability, and spare-parts information.
Recycled content and recyclability information.
Compliance documentation and conformity information.
Supply-chain and manufacturing information.
Instructions for repair, reuse, recycling, or end-of-life treatment.

Certain batteries are among the first major product categories for which an EU battery passport becomes mandatory, with the relevant requirements applying from 18 February 2027. Other product categories will follow as the Commission adopts product-specific rules under the ESPR.

Businesses should therefore maintain their GPSR technical documentation independently while also monitoring whether their product category becomes subject to a separate DPP requirement.

Need an EU Digital Product Passport?

EaseCert provides a complete EU Digital Product Passport (DPP) Creation & Implementation Service, including product data and documentation review, DPP creation, a dedicated online product passport, QR-code implementation and compliance support.

Get Your Digital Product Passport →

DPP Creation • Online Product Passport • QR Code • Implementation Support

Packaging, EPR & the PPWR

Packaging compliance is separate from the GPSR technical-file requirement but increasingly forms part of a product’s wider EU compliance framework.

Regulation (EU) 2025/40 on Packaging and Packaging Waste (PPWR) has applied from 12 August 2026. Depending on the product, packaging type, Member State, and economic operator, businesses may need to address requirements relating to packaging composition, minimisation, recyclability, labeling, documentation, and Extended Producer Responsibility (EPR).

National packaging EPR obligations can also require registrations and participation in approved collection or recycling systems. These obligations should be assessed separately from GPSR product-safety documentation, even where the relevant records are maintained within the same overall compliance file.

Internal Risk Assessment and Product Aspects to Consider

The technical documentation must be based on an internal risk assessment conducted by the manufacturer. When performing a risk analysis, manufacturers should consider the safety aspects listed in Article 6 of the GPSR, where relevant to the product, including:

Product characteristics, including design, technical features, composition, packaging, and instructions.
Appearance and presentation of the product.
The effect on other products where it is reasonably foreseeable that the products will be used together.
The effect that other products may have on the product being assessed.
Presentation, labeling, warnings, instructions, and information relating to safe use and disposal.
Categories of consumers using the product, particularly vulnerable consumers such as children, older persons, and persons with disabilities.
Whether a product not intended for children may nevertheless be used by children or resemble a product that is attractive to children.
Cybersecurity features where external influences, connectivity, or malicious interference may affect product safety.
Evolving, learning, or predictive functionalities that may affect product safety.

The purpose of the technical documentation is to provide objective evidence that the manufacturer has identified relevant risks, implemented appropriate risk controls, and can demonstrate that the product is safe and compliant with applicable requirements.

Technical Documentation – Model Template

The European Commission provides guidance on technical documentation, and the European Commission’s Safety Gate resources include a model template for GPSR technical documentation. The model structure includes the following sections:

Product Identification
1. Brand
2. Name of product
3. Model, type, batch, serial number, or other identification element
4. Product description
5. Picture of product
6. Packaging description
7. Picture of packaging
Characteristics and Composition of Product
1. Characteristics
2. Materials
3. Composition
Risk Analysis and Risk Mitigation Measures
1. Description of potential risks
2. Measures adopted to eliminate or mitigate those risks
3. Supporting testing, specifications, standards, warnings, or instructions where applicable
Compliance with applicable European standards or other safety specifications
Warnings and instructions for safe use

Is Lab Testing Required?

The General Product Safety Regulation requires products placed on the EU market to comply with the general safety requirement. The GPSR does not impose the same laboratory test on every product. Instead, the evidence required depends on the product, its hazards, applicable legislation, applicable standards, and the conclusions of the manufacturer’s risk assessment.

Compliance with certain European standards may provide a presumption of conformity with the general safety requirement for the risks covered by those standards. Where no such standard applies, other European or international standards, national requirements, recognised safety specifications, scientific guidance, state-of-the-art technical knowledge, and other relevant evidence may be considered.

Examples of commonly relevant standards include:

EN 71 series – Applied to toys under EU toy-safety legislation and covering areas such as mechanical and physical properties, flammability, and migration of certain elements.
EN 12520 – Specifies safety, strength, and durability requirements for domestic seating for adults.
EN IEC 60335 series – Covers the safety of household and similar electrical appliances and may be relevant under applicable electrical product legislation.

Where testing is relevant to identified product risks or required by applicable product-specific legislation, corresponding test reports should form part of the technical documentation.

Testing should be performed using appropriate methods and by laboratories with suitable technical competence. Laboratory accreditation may be required by particular legislation or conformity-assessment procedures and is strongly preferred where regulatory acceptance, reliability, or independent verification is important. However, the GPSR itself does not impose a universal requirement that every test report for every product must originate from an accredited laboratory.

What About the Declaration of Conformity?

The EU Declaration of Conformity (DoC) is an important compliance document, but it is essential to distinguish between GPSR requirements and the requirements of EU harmonisation legislation.

The GPSR does not create a general requirement for every GPSR-covered product to have an EU Declaration of Conformity. A DoC is mandatory where the product is subject to EU harmonisation legislation that specifically requires one, such as applicable legislation covering toys, electrical equipment, electromagnetic compatibility, radio equipment, machinery, personal protective equipment, and certain other regulated product categories.

For products covered only by the GPSR and not by legislation requiring an EU DoC, the core requirement is the manufacturer’s internal risk analysis and GPSR technical documentation. A manufacturer may still prepare an internal compliance declaration or similar record as part of its compliance system, but this should not be presented as a legally required EU Declaration of Conformity unless the applicable legislation provides for one.

Where an EU Declaration of Conformity is required, its exact contents depend on the applicable legislation but normally include:

The manufacturer’s name and address.
Identification and description of the product.
A statement that the declaration is issued under the sole responsibility of the manufacturer.
References to the applicable EU legislation.
References to applicable harmonised standards or technical specifications.
Notified body information where a notified body has participated in the applicable conformity-assessment procedure.
The name and signature of the person signing on behalf of the manufacturer.
The place and date of issue.

Where applicable, the Declaration of Conformity should be maintained together with the relevant technical documentation and made available to competent EU authorities in accordance with the applicable legislation. Where an EU Responsible Person or authorised representative has responsibilities relating to the documentation, that economic operator must have access to the documentation necessary to perform its legal duties.

Responsible Person for GPSR Compliance

Under Article 16 of the GPSR, a product covered by the Regulation may only be placed on the EU market if there is an economic operator established in the Union responsible for the product.

The applicable Responsible Person depends on the supply-chain structure:

If the manufacturer is established in the EU, the manufacturer is the responsible economic operator.
If the manufacturer is established outside the EU and the product is imported into the EU, the importer normally acts as the responsible economic operator.
Where applicable, an EU-established Authorised Representative may perform the relevant functions where it has been properly appointed by written mandate.
If none of the preceding economic operators exists in the EU, an EU-established fulfilment service provider may become the responsible economic operator where the legal conditions are met.

For products manufactured outside the EU, the name and contact details of the EU Responsible Person must be provided in accordance with the GPSR. The information must be shown on the product, its packaging, the parcel, or an accompanying document as permitted by the applicable requirements.

For distance sales, including sales through websites and online marketplaces, the product offer must also display required product-safety and traceability information. This includes product identification, manufacturer information, the EU Responsible Person information where the manufacturer is outside the EU, and applicable warnings or safety information.

Safety Gate and Safety Business Gateway

The EU Safety Gate system supports market surveillance and communication concerning dangerous non-food consumer products. It is important to distinguish the different obligations within the system.

Providers of online marketplaces must register with the Safety Gate Portal and provide their single point of contact under Article 22 of the GPSR.
Ordinary manufacturers, importers, distributors, or operators of their own online stores are not subject to this marketplace-registration requirement merely because they sell products online.
Economic operators must, however, use the relevant EU product-safety notification mechanisms, including the Safety Business Gateway, when notification obligations relating to dangerous products or safety incidents arise.
Businesses selling online must ensure that their online product listings contain the mandatory GPSR information applicable to distance sales.

More information is available in our guide to EU Safety Gate and online marketplace obligations.

Who Will Review the Documentation?

Technical documentation is not generally submitted to an authority for pre-approval under the GPSR. Instead, it must be maintained by the manufacturer and made available upon request to national market surveillance authorities.

Requests may arise as a result of:

Routine customs or market-surveillance checks.
Targeted product-sector enforcement campaigns.
Consumer complaints or reports of safety incidents.
Safety Gate notifications or investigations.
Testing performed by authorities.
Suspected non-compliance identified in physical or online sales channels.

Market-surveillance authorities may assess the technical documentation, product labeling, risk assessment, applicable testing, traceability information, and other evidence to determine whether the product meets applicable EU safety requirements.

Online marketplaces such as Amazon may also request technical documentation, test reports, Declarations of Conformity where applicable, Responsible Person information, product labels, or other compliance evidence before allowing a product to be listed or continuing to make it available for sale.

The EU’s Safety Gate 2025 report shows a high level of product-safety enforcement across Europe. Our post about Europe’s Most Active Product-Safety Authorities in 2025 explains which national authorities filed the most alerts, how this affects GPSR labeling and documentation, and how businesses can take a proportionate approach to language and market coverage.

Consequences of Non-Compliance

Failure to prepare or provide adequate technical documentation, or failure to demonstrate that a product is safe, may result in measures such as:

Requests for additional documentation or testing.
Corrective labeling or documentation requirements.
Removal or suspension of online listings.
Restrictions on making the product available on the EU market.
Withdrawal of products from distributors and retailers.
Consumer warnings or product recalls.
Notifications through the Safety Gate system.
Fines or other penalties imposed under applicable national law.

The GPSR aims to ensure that only safe products are made available to consumers in the EU, and appropriate technical documentation is a central element in demonstrating compliance.

References

Show more insights

Service successfully added