Guidance for Preparation of Documentation File(s)
Guidance for preparation of documentation file(s) which - shall be submitted to the Notified Body for CE-Conformity Assessments according to AIMDD Annex 2, Item 4 Design Dossier AIMDD Annex 3, Item 3 Device Documentation MDD Annex II, Item 4 Design Dossier MDD Annex III, Item 3 Device Documentation IVDD Annex IV, Item 4 Design Dossier IVDD Annex V, Item 3 Device Documentation ................
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