anx_ANNEX__table_1__row_5

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 14a(1)(d) and Article 15(1), (6) and (7) 5. Clinical Investigation: (a) Manufacturer, where applicable authorised representative (see fields under 1. Actor); (b) Device (see fields under 2. Device); (c) Title of investigation; (d) Protocol number; (e) Primary objective; (f) Competent Authority Contact for this Clinical Investigation; (g) Decisions taken by Competent Authority pursuant to Article 15(6), date of decision and grounds; (h) Early termination on safety grounds pursuant to Article 15(7), date of decision and grounds.

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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.