Transcription of Technical Documentation - Red de Tecnologías …
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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 date accepted amended withdrawn Page 3 4 1/21 VdT V Technical Secretariat NB-MED PO Box 10 38 34 D-45038 Essen G. Hinrich Schaub (- 178) J rg H ppner (- 138) Kurf rstenstra e 56 D-45138 Essen Phone: ++49/201/8987- 0 Fax: ++49/201/8987- 120 eMail: vdtuev-document dn.
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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Guidance for manufacturers and Notified Bodies, Guidance, Notified, Tasks of Technical Documentation Assessment, GUIDELINES ON MEDICAL DEVICES IVD GUIDANCE, Guidance Note on the, Exporting to Europe and CE Marking, Exporting to Europe . And CE Marking, Medical Device Directive 93/42, Guidelines on Clinical Investigation: A, The National Poison Information Centre in