gpsria.eu

must I keep a technical file if my product has never caused problems

A file belongs to the role, not to the complaint status

Yes, in most cases the obligation to have a risk analysis and technical documentation remains in place, even if a product has never resulted in complaints or incidents. This obligation is not linked to what has happened so far, but to the role someone holds in the supply chain. Whoever qualifies as a manufacturer places the product on the market and from that moment bears the responsibility to be able to demonstrate that risks have been considered — in advance, not afterwards if it turns out something has gone wrong.

This immediately touches on the most underestimated pitfall of the GPSR: whoever sells products under their own name or brand qualifies as a manufacturer, even if the product has simply been purchased from a factory and only their own logo has been applied to it. For that party, a clean complaint history changes nothing about the obligation to maintain a file. A distributor — someone who resells products under another's brand without modifying them — does not have this specific documentation obligation; that role must primarily be able to refer to whoever is responsible and be able to pass on the information that the already prepared file provides. So the difference is not in 'has anything ever gone wrong', but in 'what role is being fulfilled here'. Doubt about this is precisely where the question of what role someone holds in the supply chain is worked out.

Where this follows from: Article 9 and Article 18

Article 9 of Regulation (EU) 2023/988 requires the manufacturer to conduct an internal risk analysis and prepare technical documentation, independent of any reported incident; Article 18 additionally governs traceability and the retention period for that documentation. What exactly must be included in such a file and how that risk analysis is built up is described at preparing a risk analysis and technical documentation; questions about the retention period itself are addressed at the retention period for product documentation.

Where this is based on

The regulation itself is on EUR-Lex. We cite evidence for each statement; you do not need to take our word for it.

What you must do concretely

The implementation of each obligation, including the deadlines and templates to document them, is included in the subscription.

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This is not legal advice. This page provides general information about the legislation that this platform covers. We do not know your situation. If in doubt about your own case, consult a lawyer or the competent supervisory authority.

Written with AI based on the sources above, reviewed by a human on 2026-09-05. Is something incorrect? Let us know — corrections take priority.