Can a manufacturer just sign a declaration instead of doing a risk analysis under GPSR?

A manufacturer cannot replace a GPSR risk analysis with a signed declaration. Under the General Product Safety Regulation (EU) 2023/988 (GPSR), manufacturers must be able to demonstrate product safety, which normally means maintaining a documented internal risk analysis and supporting evidence. A declaration can form part of your compliance file—especially under other EU product rules—but it does not remove the need for risk-based substantiation, documentation, and traceability.

Can a manufacturer sign a declaration instead of doing a risk analysis under GPSR?

No. A signed statement does not substitute for the documented internal risk analysis expected under GPSR to show that a consumer product is safe under normal and reasonably foreseeable conditions of use. Authorities and marketplaces typically look for the underlying reasoning and evidence, not just a signature.

Some products are also subject to EU harmonisation legislation (often linked to CE marking), under which an EU Declaration of Conformity may be required. GPSR itself is not a CE-marking directive and does not make a Declaration of Conformity the core proof of safety. Even when a declaration exists under other rules, you still need a GPSR-aligned risk assessment and technical documentation that substantiates why the product is safe.

What does a GPSR risk analysis need to cover for consumer products?

A GPSR risk analysis should identify relevant hazards and show how you reduced risks to an acceptable level for consumers, including foreseeable misuse. It should be documented, kept with your technical documentation, and updated when the product changes or when the risk profile changes.

Hazard identification (mechanical, chemical, electrical, thermal, choking, strangulation, etc.)
Normal use and reasonably foreseeable use and misuse
Consumer groups, including vulnerable consumers (children, older people, persons with disabilities)
Severity and likelihood evaluation, and the overall risk level
Risk reduction measures (design changes, guards, limits, software controls, packaging)
Warnings, age suitability, and instructions for safe use and disposal, in the appropriate EU languages
Traceability inputs (model identification, batch or serial logic, label content)
Post-market monitoring plan (complaints, safety signals, corrective actions)

This analysis should connect to the rest of your file, such as the standards applied, test outcomes where appropriate, and the exact safety information shown on the product, packaging, and listing.

What documents can market surveillance authorities ask for under GPSR?

Market surveillance authorities can ask for documentation that proves product identity, traceability, and safety substantiation under GPSR. Under the Market Surveillance Regulation (EU) 2019/1020 (MSR), an EU-based Responsible Person must be able to make certain information available to authorities upon request, so your documentation needs to be organised and readily retrievable.

Product identification and traceability data (type, batch, serial, model mapping, manufacturer contact details)
The internal risk analysis and the risk-control rationale
Test reports and a list of standards used (including notes on partial application where relevant)
Instructions, warnings, and safety information, including the language versions used in each Member State
Label and packaging evidence showing required markings and contact details
Complaint and accident records, and how you assessed safety signals
Corrective actions, withdrawal, or recall documentation when applicable

In practice, authorities expect timely access to clear, consistent files. If identifiers do not match across labels, reports, and listings, requests tend to escalate.

How can a Responsible Person help you meet GPSR documentation and risk assessment expectations?

A Responsible Person—meaning an EU-established economic operator designated for your products—helps you meet GPSR expectations by ensuring documentation is complete, consistent, and available for authority requests. The Responsible Person does not manufacture the product and does not replace your duty to assess risks, but it can help you operationalise compliance.

Check whether your risk assessment and technical documentation are present and coherent
Store documentation and retrieve it quickly when authorities request it
Act as a liaison with market surveillance authorities for documentation handling
Flag gaps, mismatches, or missing traceability elements before they cause listing blocks
Under MSR Article 4, notify the manufacturer when there is reason to believe a product presents a risk

How EARP helps with GPSR risk analysis and documentation readiness

When you need an EU-based Responsible Person set up and your GPSR documentation ready for authority and marketplace scrutiny, [COMPANY] supports you with practical, compliance-focused execution:

We provide EU Responsible Person and EU Authorised Representative coverage aligned with your product and supply chain setup.
We check your documentation package for completeness and consistency, including the presence of a risk assessment, traceability, and safety information.
We store documentation and make it available to market surveillance authorities when requested, using established retrieval processes.
We guide you on what evidence is typically needed to substantiate safety under GPSR, without taking over your manufacturing responsibilities.

Review our services, or contact us to discuss your products and the fastest path to GPSR-ready documentation.