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Technical Documentation

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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. date accepted amended withdrawn Page 3 4 1/21 VdT V Technical Secretariat NB-MED PO Box 10 38 34 D-45038 Essen G.

market. For example, it is unlikely that well-established products, regardless of their classifi-cation, will have much formal design validation - but the manufacturer will have considerable market experience of use, together with details on how he has responded to any problems that have emerged, and this available data should be

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