art_2__text_2

2010/227/EU: Commission Decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (notified under document C(2010) 2363) (Text with EEA relevance) · European Union

For clinical investigations Member States shall ensure that an extract of the notifications referred to in Article 10(1) of Directive 90/385/EEC and in Article 15(1) of Directive 93/42/EEC, as well as the information referred to in Article 10(3) and (4) of Directive 90/385/EEC and in Article 15(6) and (7) of Directive 93/42/EEC are entered into Eudamed in accordance with the Annex to this Decision.

National law under this provision

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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.