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Recast Clinicals

Recast Clinicals. Dr. Wolfgang Ecker CIE. Recast Clinicals. CIE has set up Task Force for Recast COM, FR, DE, IR, AT, PT, SE, UK; EUCOMED Presentation to COM: Autumn 2010. Recast Clinicals Clarification of Concepts. State of the art Sponsor of a Clinical Investigation PMCF

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Recast Clinicals

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  1. Recast Clinicals Dr. Wolfgang Ecker CIE

  2. Recast Clinicals • CIE has set up Task Force for Recast • COM, FR, DE, IR, AT, PT, SE, UK; EUCOMED • Presentation to COM: Autumn 2010

  3. Recast ClinicalsClarification of Concepts • State of the art • Sponsor of a Clinical Investigation • PMCF • (Clinical) Performance; Efficacy; Effectiveness; Clinical Acceptance Criteria • SAE + related terms

  4. Recast ClinicalsAdministrative • Registration of all device related clinical investigations • Registration of PMCF-studies • SAE- versus vigilance-reporting (when do what?) • Inspections • Standardised MS-review of CI • MS-Cooperation and work-sharing

  5. Recast ClinicalsEUDAMED • Full functionality of CI module • MF/AR may draw unique code • Limited access to others (NB)? • All CI? • All PMCF?

  6. Recast ClinicalsConformity Assessment • Better NB-Competence • Art 16 • Comitology • Annex 11 • Post approval criteria • Clinical Guidelines (like IDE/PMA/CHMP-guidelines) • Cooperation with GHTF/FDA

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