GPSR Technical File Template: What Article 9(2) Requires (2026)

Under Article 9(2) of the General Product Safety Regulation (EU) 2023/988 (GPSR), every manufacturer must draw up technical documentation before placing a consumer product on the EU market: a general description of the product and its safety-relevant characteristics, plus — where the product's risks make it appropriate — an internal risk analysis with the solutions adopted, test reports, and the standards applied. The file must be kept up to date and retained for 10 years. It is not submitted anywhere and not the same as a CE technical file — this guide gives you a copyable structure and explains that difference honestly.

What is a GPSR technical file under Article 9(2)?

A GPSR technical file is the internal dossier proving you assessed your product's safety before selling it — nobody approves it, nobody stamps it, but market surveillance authorities can demand it at any time. There is no submission portal, no certificate, and no fee to any authority. The file simply has to exist, be honest, and be retrievable for 10 years (Article 9(3)).

"Manufacturer" is broad: anyone who makes a product or has it made and sells it under their own name or trademark. A candle maker on Etsy and a private-label brand sourcing from Alibaba are both manufacturers under the GPSR — there is no small-business exemption.

What exactly must GPSR technical documentation contain?

Article 9(2) sets a mandatory core plus risk-dependent additions — the core is always required, the rest scales with your product's risks.

Always required:

• a general description of the product, and
• its essential characteristics relevant for assessing its safety (materials, construction, intended users, age grading).

Where appropriate having regard to possible risks, the documentation must also contain, as applicable:

• an analysis of the possible risks and the solutions adopted to eliminate or mitigate them, including the outcome of any test reports — this is the internal risk analysis covered step by step in our GPSR risk assessment guide;
• a list of the relevant European standards or other safety elements applied to meet the general safety requirement — and if a standard was only partly applied, which parts.

In practice, add traceability records too: type/batch/serial identification (Article 9(5)), your name and postal + electronic address (Article 9(6)), and records of who supplied your materials or finished goods — authorities expect you to identify your suppliers. One honest nuance: the risk analysis itself must always be carried out before sale; only its written depth is proportionate to the risk. For any real product, include it.

How is a GPSR technical file different from a CE technical file?

They come from different laws and are not interchangeable — GPSR documentation is a lighter, self-directed dossier, while a CE technical file follows a prescribed annex under product-specific harmonised legislation. Under Article 2 GPSR, where Union harmonisation legislation covers your product's safety (toys, electrical goods, PPE, machinery and more), the GPSR manufacturer obligations — including Article 9(2) — do not apply to those covered risks; the harmonised act's own technical file rules apply instead. GPSR then only fills aspects that legislation leaves uncovered.

	GPSR technical documentation	CE technical file
Legal basis	Reg. (EU) 2023/988, Art. 9(2)	Product-specific acts, e.g. Toy Safety Directive 2009/48/EC Annex IV, Low Voltage Directive 2014/35/EU
Typical products	Candles, jewelry, ceramics, furniture, home textiles, decor	Toys, electronics, PPE, machinery, radio equipment
Conformity procedure	None — internal risk analysis only	Formal conformity assessment; sometimes a notified body
EU Declaration of Conformity	Not required	Required
CE marking	Not required — and not permitted	Required
Content	Description, risk analysis, standards, evidence — structure up to you	Prescribed by annex: design drawings, schematics, test reports against harmonised standards

Stating it plainly: CE-marking a product not covered by CE legislation is unlawful, not "extra safe" — and if your product is covered by harmonised legislation, this template alone is not enough.

What does a complete GPSR technical file look like? (copyable template)

A proportionate file for a typical marketplace product has eight sections — copy this table as your table of contents and fill each row.

#	Section	What to include	Basis
1	Product identification & traceability	Product name, SKU/model, type/batch or serial number, your business name, postal and electronic address; Responsible Person details if appointed	Art. 9(5), 9(6)
2	General product description	Materials, components, dimensions, how it is made, packaging; photos of the product, label, and packaging	Art. 9(2) — always
3	Essential safety characteristics	What determines the product's safety: construction, intended users and age range, use environment, foreseeable misuse	Art. 9(2) — always
4	Internal risk analysis	Hazard identification, probability × severity scoring, mitigations, residual risk conclusion — see the full structure here	Art. 9(2)
5	Applied requirements & standards	Relevant EN standards (e.g. EN 15493 for candles), REACH restrictions checked, voluntary schemes; note partial application	Art. 9(2)
6	Test reports & supplier evidence	Lab test reports where relevant to the risks, material certificates, supplier declarations, purchase records	Art. 9(2)
7	Labels, warnings & instructions	Final label artwork, exact warning wording, instructions in the languages of your target markets	Art. 9(7) context
8	Document control	Version, date, author, signature; review triggers (supplier change, material change, complaint); 10-year retention note	Art. 9(3)

Keep it digital, dated, and versioned. A well-made file for a low-risk product can be under ten pages; the regulation demands honesty and completeness, not volume.

Who must keep the technical file?

The manufacturer always; a private-label brand is treated as the manufacturer; an importer must verify it exists and be able to produce it.

Role	Duty	Basis
Manufacturer	Draw up the file, keep it updated, retain 10 years	Art. 9(2)–(3)
Private-label brand	Selling under your own name or trademark makes you the manufacturer — you need your own file, even if a factory made the product	Art. 13(1)
Importer	Verify the manufacturer complied with Art. 9(2), (5) and (6) before importing; ensure the documentation can be made available to authorities for 10 years	Art. 11
Responsible Person / authorised rep	Verify the documentation was drawn up; keep it at the disposal of authorities	Art. 16 GPSR + Reg. (EU) 2019/1020 Art. 4(3)
Distributor	No file duty, but must act with due care and verify labeling and traceability are in place	Art. 12

A private-label brand can build its file on supplier test reports and certificates — but the legal responsibility, and the signature on the risk conclusion, is yours, not the factory's. If you appoint an EU Responsible Person, expect them to ask for the file before accepting you.

What will market surveillance authorities ask for?

On request, you must make the technical documentation available — typically the risk analysis, evidence behind your safety claims, traceability records, and your labels come first. The GPSR prescribes no format and no filing; a well-organized PDF is fine. It sets no explicit language rule for the file, but an authority may ask for a translation — practice varies by member state.

Typical requests, often routed through your Responsible Person:

• the internal risk analysis and residual-risk conclusion;
• test reports or certificates supporting any standard you claim to apply;
• traceability: batch records and who supplied you;
• label, warning, and instruction artwork as actually shipped;
• evidence of corrective action if an incident was reported via the Safety Business Gateway.

Slow or empty answers escalate quickly: authorities can restrict or withdraw a product, and marketplaces routinely delist first and ask later.

What are the most common mistakes?

• Confusing it with a CE file — either doing GPSR-lite paperwork for a toy that needs a full Toy Safety Directive file, or CE-marking a candle that must not carry the mark
• Writing it after the sale — Article 9(2) says before placing on the market
• A description with no risk analysis — the two mandatory bullets alone rarely reflect a real product's risks
• No supplier trail — invoices and supplier details missing, so batches cannot be traced when a question comes
• Letting it rot — a supplier or material change without a file update quietly invalidates it; retention is 10 years, not 10 months

What should you do next?

The fastest route is to assemble the eight sections above for one product, starting with the risk analysis. If you want a head start, generate the documents for your product — €14: EUSellKit builds a GPSR document pack — risk assessment, technical file structure, and label content — from your product's details, one-time per product.

This guide is general information, not legal advice.