Recast Clinicals

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