# The 3 Documents Every CE-Marked Product Must Have

Most hardware teams know about the CE mark itself. Few have all three of the
underlying documents right. This short covers the Declaration of Conformity,
the Technical File, and the Instructions for Use — what each one is and
what goes in it.


## Transcript

### Three documents, one defensible position

Three documents turn CE marking from a logo on a label into a legally defensible compliance position. Most companies know the first one. Many forget the second. Almost everyone underbuilds the third.

### What each one is

First: the Declaration of Conformity — signed, naming the product, directives, and standards applied. Second: the Technical File — test reports, risk assessment, circuit diagrams, design docs. Market surveillance can request it within ten days. Third: Instructions for Use, in every market's language.

### The most common mistake

The technical file is where teams cut corners. A sparse file — missing test reports, no risk assessment, outdated standards — doesn't support the declaration you signed. If an authority requests it and evidence fails, your DoC is invalid.

Tags: CE marking, Declaration of Conformity, technical file, documentation