Glossary
Technical file
A technical file (or technical documentation) is the internal evidence pack that proves a product meets its applicable requirements: design and manufacturing drawings, standards applied, test reports, and a risk analysis. It is not published or submitted anywhere by default.
Why it matters
You must be able to produce the technical file within days of a market surveillance request, typically for ten years after the last unit is placed on the market. Manufacturers who cannot produce one when asked are treated as non-compliant regardless of how safe the product actually is.