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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

Article 12(1)(a) and Article 10(1), (3) and (4) and Annex VIII (4) 9. Actor (for all in vitro diagnostic medical devices (IVD’s): Address of manufacturer, respectively authorised representative (see fields under 1. Actor). 10. Device: For all IVD’s (a) Device (see fields under Device 2.); (b) Information on whether device is ‘new’; (c) Discontinuation of placing on the market. In addition for Annex II and self-testing (d) Outcome of performance evaluation, where applicable; (e) Certificates (see fields under 3. Certificate); (f) Conformity with Common Technical Specifications, where applicable; (g) Identification of device.

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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.