(b)

further to a reasoned request from a market surveillance authority, provide authorities of the Member State concerned with a copy of the mandate and all the information and documentation necessary to demonstrate the conformity of an EHR system with the essential requirements laid down in Annex II as well as the common specifications referred to in Article 36;

← (a) · All articles · (c) →

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