GPSR Risk Assessment and Risk Analysis
Grüner Baum GmbH reviews product risks, technical evidence and documentation gaps under GPSR Article 9. The assessment is product-specific and does not assign one fixed level to a product category.
What does Grüner Baum review in a GPSR risk assessment?
Grüner Baum GmbH reviews the technical documentation for one product family, maps hazards and harm scenarios, and identifies evidence gaps. A detailed review costs €129 excluding VAT per product family; high-risk products and products under specific EU legislation are quoted separately.
| Price | €129 / product family |
|---|---|
| Deliverable | A written review of product risks, available evidence, document gaps and the next actions required. |
| Inputs needed | Product description, intended users and use, material and supplier data, warnings, applicable standards, test reports and product images. |
| Scope | One product family sharing the same intended use, basic design, material, manufacturing and safety profile. Material differences are assessed separately. |
| Legal boundary | The review is not an authority approval or certification. The manufacturer remains responsible for product safety and technical documentation. |
Beyond the free initial risk analysis included in the packages; covers a formal, detailed review of technical documents, test reports, product information and the risk assessment from a GPSR perspective. High-risk products or products subject to specific legislation are quoted separately.
Does every product need a GPSR risk assessment?
A manufacturer must document the product and the characteristics essential for assessing its safety. Where appropriate in relation to possible risks, the technical documentation also contains a risk analysis and the solutions adopted to eliminate or mitigate those risks, including relevant test results. This is product-specific: the GPSR does not demand the same template, an accredited laboratory or an independent third-party assessment for every consumer product.
How do EU Safety Gate (formerly RAPEX) alerts affect a risk assessment?
Safety Gate alerts describe dangerous non-food products, identified risks and corrective measures reported by EU and EEA authorities. Reviewing alerts for the same or similar products can reveal known hazards and support an up-to-date assessment, but an alert search does not replace product-specific analysis, testing or applicable standards. RAPEX is the former name associated with the system.
2026 guide to Safety Gate and RAPEX alerts for baby and children's products →
This page reflects the product-risk and technical-documentation review practice of Germany-based Grüner Baum GmbH. Reviewed by Hatice Muazzez Bodur →
How are GPSR risk levels determined?
Delegated Regulation (EU) 2024/3173 uses serious, high, medium and low levels for Safety Gate assessments. Each harm scenario combines severity with overall probability; a product category does not have a fixed risk level.
| Level | Definition | Harm-scenario example | Decision basis |
|---|---|---|---|
Serious | One harm scenario reaches serious in the EU matrix through its combination of harm severity and overall probability. | Example: a detachable small part can obstruct a child's airway. The level follows only after evidence supports the complete chain of events. | Harm severity, vulnerable users, exposure and the probability of every step in the chain of events. |
High | The severity and overall probability for a specific harm scenario combine in the high field of the EU matrix. | Example: component failure can cause serious injury, but the supported probability does not produce a serious result. | Product-specific tests, conditions of use, exposure and documented probability assumptions. |
Medium | The matrix places the specific harm scenario at medium because of lower severity or probability. | Example: a foreseeable pinch point can cause a treatable injury; frequency and use conditions affect the result. | Scenario, harm severity, frequency of use, user group, existing safeguards and evidence. |
Low | Severity and probability combine in the low field. Identified low risks are still documented. | Example: a rough edge can cause a superficial injury during reasonably foreseeable contact. | Reasoned matrix values, existing controls and the risk remaining after those controls. |
What should a GPSR risk analysis contain?
The GPSR does not prescribe one universal manufacturer template. A defensible risk analysis should still record product identity, use, affected people, hazards, individual harm scenarios, severity and probability, evidence, controls and residual risk.
| Field | What to record |
|---|---|
| Product and use | Model or product family, intended use, reasonably foreseeable misuse and target markets. |
| People exposed | Users, third parties and vulnerable groups such as children, older people or people with disabilities. |
| Hazard and scenario | Hazard source, sequence leading to harm, type of injury and each relevant variation of the scenario. |
| Evaluation | Severity of harm, probability of each step, overall probability and the reasoned risk level. |
| Controls and evidence | Design measures, warnings, standards, test reports, Safety Gate findings and remaining risk. |
| Version and update | Date, responsible person, product version and triggers for reassessment. |
GPSR Article 9 concerns the manufacturer's internal risk analysis. Delegated Regulation (EU) 2024/3173 instead sets the current Safety Gate risk-level method for authorities. Its matrix can help structure an assessment, but it does not classify a product category automatically.
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Start the initial screening →Official sources for GPSR risk assessment
- Regulation (EU) 2023/988, Article 9 — EUR-Lex — Article 9 requires the manufacturer to carry out an internal risk analysis and keep product-specific technical documentation up to date.
- Delegated Regulation (EU) 2024/3173 — EUR-Lex — The method applicable since 22 December 2024 defines serious, high, medium and low levels for Safety Gate assessments by combining severity and probability.
- European Commission Safety Gate alerts — The Commission database provides current dangerous-product alerts, identified risks and measures; relevant cases are supporting evidence, not a substitute for the product analysis.
Frequently Asked Questions
What is a GPSR product risk analysis?
A product risk analysis identifies reasonably foreseeable hazards, considers how the product may be used, who may be exposed and how serious the possible harm could be, then records measures used to eliminate or reduce those risks. Under Article 9(2), this analysis belongs in the technical documentation where it is appropriate to the possible risks of the specific product.
When should a product risk analysis be updated?
It should be revisited when a change to the product, materials, manufacturing process, intended use, warnings or new safety evidence could affect the assessment. The manufacturer must keep technical documentation up to date. The GPSR does not prescribe one universal annual review interval for every product, so the review trigger and depth should follow the product's actual safety profile and applicable sector rules.
Can a risk analysis be prepared internally?
The manufacturer remains responsible for the product and its technical documentation and may use suitable internal expertise or external support. The GPSR does not impose a universal requirement that every analysis be produced by an accredited laboratory or independent third party. Separate product legislation, standards, contractual requirements or the nature of a necessary test may nevertheless require a particular conformity-assessment route or competent facility.
Which standards and tests belong in the assessment?
That depends on the product, its hazards and all applicable EU product legislation. Relevant standards and test results can support the safety analysis, but a generic list cannot determine compliance for every product. The manufacturer should identify the legal framework first, then document the methods, evidence and risk-control measures that are appropriate for the specific product and its reasonably foreseeable use.
What happens to the assessment after an accident or recall?
The manufacturer should reassess the product using the new facts, update the technical documentation and record corrective measures. GPSR Article 20 governs accident reporting through the Safety Business Gateway; where the manufacturer is outside the EU, the Responsible Person ensures that the report is made. The precise corrective action depends on the risk, the product and any direction from the competent authority.
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