Technical Documentation
Co-ordination of Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC Recommendation NB- Title: Technical Documentation Chapter: Conformity assessment procedures; General rules Text: ........................................ . Key words: Design dossier, Technical Documentation , Technical file A rationale and history sheet is available; please contact Technical Secretariat. Reference to Directives: Article/ Annex: Reference to standards: AIMD Annex: 2, 3, 4, 5 MDD Annex: II, III, IV, V, VI, VII IVD Annex: III Stage proposed by Rev.
Co-ordination of Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC Recommendation NB-MED/2.5.1/Rec5
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