The technical file.

Complete, current, accessible

The technical file is more than an administrative duty. It is the argumentation base in any dispute about a product's conformity — with authorities, customers, insurers, courts. A complete, current, well-organised file defends itself. A missing file does not.

Three requirements are non-negotiable. Completeness: all required documents present. Currency: the file describes the product actually on the market. Accessibility: when the authority asks, you find it within hours.

Every product change is checked for compliance relevance. New colour — possibly different pigments with different REACH profiles. New supplier — possibly different material. Without systematic change management, after a while the file no longer describes the product being sold.

What a complete file delivers

A complete technical file is the prerequisite for everything else: CE marking, retailer listing, authority audit, insurance cover.

Retention: ten years from placing the last product on the market. Longer for medical devices. Digital archiving is permitted — readability over the full retention period must be ensured.

Case: Amazon delisting in three hours

A Swiss maker of kitchen appliances has been selling on Amazon.de for two years. Revenue: EUR 80,000 per month. A competitor files a complaint with the German market-surveillance authority over missing CE marking on packaging. The authority opens proceedings. Safety Gate entry triggered.

Amazon delists all affected ASINs within three hours of the Safety Gate entry. The manufacturer learns of it from an automated Amazon email. No prior notice. No advance appeal. The technical file exists — in an inaccessible folder on the laptop of the staff member who has been on parental leave for two months.

23 days to listing restoration. EUR 184,000 in lost revenue. The underlying lesson: the file must be retrievable at any time. Not somewhere. Immediately.