art_37__para_3

Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance) · European Union

3. The technical documentation referred to in paragraph 1 shall be drawn up in an official language of the Member State concerned or a language that is easily understandable in that Member State. Following a reasoned request from the market surveillance authority of a Member State, the manufacturer shall provide a translation of the relevant parts of the technical documentation into an official language of that Member State.

← art_37__para_2 · All articles · art_37__para_4 →

Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.