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rec_9

(9) Member States should only be required to enter data existing before 1 May 2011 to the extent required for the future functioning of Eudamed. It is necessary for the completeness of Eudamed to enter data existing before 1 May 2011 on the manufacturer, the authorised representative and on device registration, which are required by Directives 93/42/EEC and 98/79/EC, in the form in which such data are available at national level.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.