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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 14a(1)(c) and Article 10(3) 4. Incident (National Competent Authority Report): (a) Competent Authority reference; (b) Manufacturer, where applicable authorised representative (see fields under 1. Actor); (c) Manufacturer contact; (d) Manufacturer reference/Field Safety Corrective Action (FSCA) nr.; (e) Device (see fields under 2. Device), plus where applicable lot number, serial number, software version; (f) Notified Body (selected from system); (g) Device known to be in the market in; (h) Confidential; (i) Complete investigation; (j) Background Information (Description); (k) Conclusion; (l) Recommendation; (m) Action and action description.

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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.