GPSR technical documentation is not a single certificate or a set of random attachments from a supplier. It should show which product was assessed, which risks were considered, what evidence the conclusions were based on, and who approved the decisions and when.
Who is responsible for preparing the documentation
GPSR places an obligation on the manufacturer to carry out an internal risk analysis before placing the product on the market and to draw up technical documentation. Its minimum element is a general description of the product and its essential characteristics relevant to the safety assessment.
Where appropriate in view of the possible risk, the documentation should also include an analysis of hazards, the solutions used to eliminate or mitigate them, and the results of tests carried out by or on behalf of the manufacturer. A list of the standards applied or other safety assessment criteria may also be relevant.
The importer should not assume that the manufacturer's obligation relieves it of an interest in the documentation. GPSR requires the importer to verify that certain manufacturer obligations have been fulfilled, to keep a copy of the technical documentation for 10 years from the placing of the product on the market, and to be able to provide the relevant documents to the market surveillance authority.
Start with the product scope
First, you need to determine exactly what the dossier covers. A general category name is usually not enough.
The identification sheet should organise:
- the product name and intended use,
- the type, model, series, batch or other identifier,
- the SKU numbers covered by the documentation,
- photographs of the product, packaging and markings,
- material, dimensional or functional variants,
- the manufacturer, importer and responsible person in the EU,
- the markets and user groups,
- the design version and the period to which the evidence relates.
If several SKUs are to use the same documentation, record the justification. A shared packaging colour does not mean that the products have the same safety characteristics. Conversely, technically identical variants may use some common evidence, provided that the scope of such reuse is transparent and justified.
What elements are worth keeping in the dossier
The scope always depends on the product, but an operational documentation structure may include the following groups of information.
Product and operation description
Describe the design, composition, materials, technical parameters, mode of operation and intended use. Add reasonably foreseeable ways of misuse if they could affect safety.
The document should correspond to the actual product. If the supplier changes the material, power supply, coating, closing mechanism or instructions, you need to assess whether the existing version of the documentation is still up to date.
Risk analysis
The risk analysis should link the hazard to the use situation, the potential consequence, the group of exposed users and the mitigation measure adopted. A mere list of general headings without reference to the product is a weak basis for a decision.
GPSR requires looking at, among other things, the product's characteristics, its interaction with other products, the way it is presented, groups particularly vulnerable to hazards and - where applicable - cybersecurity and learning functions.
Tests and other evidence
The dossier may include test reports, calculations, material specifications, safety data sheets, quality control records, photographs of markings and supplier declarations. Each piece of evidence should have its scope described.
Check:
- who issued the document,
- which product and variant it concerns,
- when the test or assessment was carried out,
- which method, standard or criterion was applied,
- what results and limitations were indicated,
- whether the document remains valid after product changes.
A file name is not a substantive assessment. A document may be authentic but inadequate for the given model or the risk under consideration.
Standards and assessment criteria
If the company relies on a standard, you must record its full designation, edition, scope of application and evidence that the relevant requirements were actually used. A list of standards copied from a similar product is not sufficient.
A standard is one of the possible elements of a safety assessment. Depending on the product, you must also take into account sectoral rules, the current state of knowledge, good practices and reasonable consumer expectations.
Instructions, warnings and marking
The documentation should retain the approved content of instructions and safety information. It is also worth keeping label designs, photographs of their placement and language variants.
Every piece of content should have a source. A warning should stem from an identified hazard and the adopted risk mitigation method, not from an automatic generator detached from the product.
Decisions and follow-up actions
The dossier does not end on the day of first sale. Include information on complaints, accidents, safety-related claims, supplier changes and corrective actions. This allows a new signal to be linked to an earlier analysis.
Source, version and responsibility
The biggest problem with many sets of documentation is not the lack of files, but the lack of answers to three questions: where a piece of information comes from, which version it concerns and who approved it.
For each material value or document, record:
- the source and date received,
- the assigned product or product group,
- the version number,
- the status: draft, for review, approved or withdrawn,
- the author or supplier of the information,
- the person responsible for review,
- the reason for and scope of the change.
An approved revision should not be overwritten. New information should create another version, so that the company can reconstruct the state of the documentation in force at the time of a particular delivery or sale.
General documentation and sectoral rules
GPSR applies to consumer products to the extent that a given risk is not covered by specific Union rules with the same objective. A product may therefore require several legal regimes to be considered in parallel.
For example, a toy, an electrical device or personal protective equipment may be subject to specific procedures, marking and documents. These requirements should not be replaced by a general GPSR checklist. The dossier should clearly indicate which evidence arises from which basis and which area of risk it covers.
Proposed folder or system structure
- 01 Product identification - product sheet, SKUs, variants, photographs and entities.
- 02 Legal scope - markets, the company's role, rules and standards applied.
- 03 Risk analysis - hazards, users, mitigation measures and conclusions.
- 04 Evidence - reports, specifications, declarations and an assessment of their adequacy.
- 05 User information - labels, instructions, warnings and languages.
- 06 Online sales - the approved set of information for listings.
- 07 Changes and incidents - complaints, accidents, corrective actions and subsequent revisions.
- 08 Approvals - responsible persons, dates and the basis for decisions.
Such an arrangement does not determine whether a product is compliant. However, it makes it easier to find gaps, reduces the use of outdated versions and allows you to check what a particular decision was based on.
Spreadsheet, drive or controlled system
A spreadsheet may be sufficient for a simple pilot, but as the number of SKUs grows, problems arise with links, permissions and change history. A drive stores files but usually does not show whether a document has been assessed, which variant it concerns and whether a later revision has superseded it.
A controlled system should link product data with the supplier, packaging, source, status and approved revision. It still does not replace technical knowledge, testing or the decision of a responsible person. Its role is to organise work and preserve an evidence trail.
Quick completeness check
Before approving the documentation, answer the following questions:
- Is it clear exactly which product and variant it concerns?
- Does the description correspond to the version currently being sold?
- Does the analysis cover foreseeable use and relevant user groups?
- Does each key conclusion have an identified source or evidence?
- Do the instructions and warnings stem from an identified risk?
- Have sectoral rules been taken into account?
- Is the approving person aware of the gaps and limitations of the material?
- Can the previous version still be reconstructed?
If the answer to any question is 'not known', the documentation is not yet ready for informed approval. First mark the gap, assign an action owner and a deadline for completion.