Article 17 Technical documentation

The technical documentation shall contain all relevant data and details of the means used by the manufacturer to ensure that the product complies with the requirements set out in Parts 1 to 6, 16 and 17 of the Annex. It shall, at least, contain the elements set out in Part 10 of the Annex.

The technical documentation shall be drawn up before the product is placed on the market and shall be continuously updated.

The technical documentation and correspondence relating to any F2type examination procedure or the assessment of the quality system of the manufacturer shall be drawn up in F3English.

Where the technical documentation does not comply with paragraphs 1, 2 or 3 of this Article, the market surveillance authority may ask the manufacturer or the importer to have a test performed by a body acceptable to the market surveillance authority at the expense of the manufacturer or the importer within a specified period in order to verify compliance of the product with the requirements set out in Parts 1 to 6, 16 and 17 of the Annex which applies to it.