Risk assessment and technical documentation under the GPSR
Before a consumer product is sold in the EU, its manufacturer must carry out an internal risk analysis and draw up technical documentation. ohdock turns that into a guided form and a printable file for each product.
What the GPSR asks for
- An internal risk analysis before the product is placed on the market (Article 9(2)).
- Technical documentation with at least a general description of the product and its essential characteristics for safety; depending on the risks, also the analysis of possible risks and the solutions adopted, test reports and the standards applied (Article 9(2), Annex II).
- Keeping that documentation for 10 years and giving it to market surveillance authorities when they ask (Article 9(3)).
- Taking into account who uses the product — particularly children, older people and people with disabilities — and how it is presented (Article 6).
Regulation (EU) 2023/988 (GPSR)
How it works in ohdock
- Create a record for the product, with its label details and the countries you sell to.
- Answer the questions: description, users, hazards suggested for the product type, measures, standards and tests.
- Print the risk assessment and technical file or save it as PDF. Each saved version is kept in your account.
Hazards
- Small parts — Choking, swallowing or inhaling parts that fit in a small child’s mouth.
- Sharp edges and points — Cuts and punctures from edges, points, broken parts or splinters.
- Entrapment — Fingers, limbs, head or neck caught in gaps, holes or hinges.
- Cords, straps and loops — Strangulation, especially for young children.
- Bags, films and covers — Suffocation from plastic bags or films over the nose and mouth.
- Magnets — Small powerful magnets that can cause internal injuries if swallowed.
- Button and coin batteries — Severe internal burns if swallowed; battery compartments must be secure.
- Batteries and charging — Overheating, fire or explosion, for example of lithium batteries.
- Electric shock — Live parts, damaged cables or water getting in.
- Heat and burns — Hot surfaces, flames or hot liquids.
- Flammability — The product catches fire easily or burns quickly.
- Harmful substances — Heavy metals, phthalates, allergens or other substances through skin contact, mouthing or breathing.
- Stability and strength — Tipping over, collapsing or breaking under normal use.
- Moving parts — Crushing, pinching or cutting by moving parts.
- Noise — Sound loud enough to damage hearing, especially close to the ear.
- Lasers and strong light — Eye injury from lasers or very bright light sources.
- Looks like food or attracts children — Shape, colour or smell that makes people — especially children — put it in their mouth.
- Connected functions — Cybersecurity or software faults that could make the product unsafe.
Risk levels use a simple severity × likelihood matrix to set priorities. It is not the official Safety Gate method.
Sample file
This is what the file looks like for an example product. Your own file uses your answers. The file is in English, which market surveillance authorities widely accept. Keep a translation if an authority asks for one.
Risk assessment and technical documentation — Wooden stacking toy (sample)
| Product | Wooden stacking toy (sample) |
|---|---|
| Type or model | WS-10 |
| Batch or serial number | B2410 |
| SKU or EAN | SAMPLE-001 |
| Manufacturer | Example Toys Co., Ltd., No. 1 Example Road, Ningbo, China, safety@example.com |
| EU responsible person | Example EU Rep GmbH, Musterstraße 1, 10115 Berlin, Germany, gpsr@example.eu |
| Markets | Germany, France, Netherlands |
| Document | Version 1, saved 2026-10-01 |
| Assessed by | Jane Example, Product Manager |
| Date of assessment | 2026-10-01 |
| Next review | 2027-10-01 |
1. General description of the product GPSR Art. 9(2); Annex II
| Description | Stacking toy of seven painted beech-wood rings on a wooden base, for children from 3 years. Base 12 cm, rings 4–9 cm. Sold in a cardboard box. |
|---|---|
| Essential characteristics (materials, components, power source, packaging) | Solid beech wood; water-based paint; no batteries or electrical parts; cardboard packaging with no plastic film. |
| Intended use | Play by children from 3 years, stacking rings on the pole. |
| Reasonably foreseeable misuse | Use by children under 3; mouthing and chewing the rings; throwing rings. |
2. Who uses the product GPSR Art. 6(1)
| Consumers | Children from 3 to 14 years, Children under 36 months |
|---|
3. Risk analysis and measures taken GPSR Art. 9(2); Annex II
| Hazard | How someone could be harmed | Severity | Likelihood | Risk | Measures taken | Residual risk |
|---|---|---|---|---|---|---|
| Small parts — choking, swallowing or inhalation | A ring or a piece of broken pole could be swallowed by a younger sibling. | 4 — very serious or fatal | Possible | High | Smallest ring is larger than the small parts cylinder; drop and torque tests passed; age warning “Not suitable for children under 36 months” on the box and the listing. | Unlikely · Medium |
| Harmful substances — skin contact, mouthing or inhalation | Paint could come off when the toy is mouthed. | 3 — serious | Possible | High | Paint tested for migration of certain elements; supplier declaration for the paint kept on file. | Unlikely · Medium |
| Sharp edges and points — cuts and punctures | Splinters or sharp edges after the toy is dropped. | 2 — moderate | Unlikely | Low | All edges rounded and sanded; visual check of every batch. | Unlikely · Low |
Risk = severity × likelihood on a simple matrix used to set priorities. It is not the official Safety Gate risk assessment method. Residual risk is the likelihood after the measures taken.
4. Standards and other references applied GPSR Art. 7–8; Annex II
EN 71-1 (mechanical and physical properties), EN 71-2 (flammability), EN 71-3 (migration of certain elements).
5. Tests and reports GPSR Annex II
Test report no. EX-2026-0001 from Example Testing Laboratory, dated 2026-09-15.
6. Instructions, warnings and safety information GPSR Art. 9(7)
| Warnings on the label | Warning: Not suitable for children under 36 months. Small parts. Choking hazard. |
|---|---|
| Own warning text | — |
| Label languages | DE, FR, NL |
| Instructions and other safety information | Age warning and instructions in German, French and Dutch on the box; keep the box for the manufacturer’s address. |
7. Identification and contact details GPSR Art. 9(5), 9(6), 16
| Identifier on the product | WS-10 · B2410 |
|---|---|
| Manufacturer | Example Toys Co., Ltd., No. 1 Example Road, Ningbo, China, safety@example.com |
| EU responsible person | Example EU Rep GmbH, Musterstraße 1, 10115 Berlin, Germany, gpsr@example.eu |
| Importer | — |
8. Complaints, accidents and corrective action GPSR Art. 9(8), 20
Customers can report problems at safety@example.com or through the marketplace. Complaints are reviewed weekly; serious incidents are reported through the Safety Business Gateway and the product recalled if needed.
9. Keeping this documentation GPSR Art. 9(2)–(3)
Keep this documentation for 10 years after the product is placed on the market and make it available to market surveillance authorities on request.
Update it when the product, its components, its users or the applicable rules change, and after any accident or complaint about safety.
Prepared with ohdock (ohdock.com) from the information entered by the manufacturer or seller.
This document records your own assessment. It is not legal advice, a test report or a certificate, and it does not show that the product complies with EU law. Check Regulation (EU) 2023/988 and any product-specific legislation, or ask a qualified adviser or testing laboratory.
Price
€19 per product, one-off — or included in EU Pro (€12 per month) for all your products.
For one product: the risk assessment and technical file, its GPSR label and listing text, kept in your account.
The listing check and the label generator stay free.
This records your own assessment. It is not legal advice, a test report or a certificate, and it does not show that the product complies. ohdock provides software tools and general information, not legal advice. Check the official texts, or ask a qualified adviser, for your situation.