(i)

take without undue delay any necessary corrective action in respect of their EHR systems, where they consider or have reason to believe that such systems are not or are no longer in conformity with the essential requirements laid down in Annex II, or recall or withdraw such systems; the manufacturers of EHR systems shall subsequently inform the national authorities of the Member States in which they made their EHR systems available on the market or put them into service of the non-conformity, of any corrective action taken, including the timetable for implementation, and of the date at which the harmonised software components of their EHR systems have been brought into conformity or been recalled or withdrawn;

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