L’IMRDF a publié de nombreux guides et documents réglementaires

Les versions finales des guides et documents réglementaires suivants ont été publiées par l’IMRDF pour être utilisés par les fabricants, les organismes notifiés et les autorités compétentes :

  • IMRDF/MDSAP WG/N8 FINAL:2015 : Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations
  • IMRDF/MDSAP WG/N24 FINAL:2015 : Medical Device Regulatory Audit Reports
  • IMRDF/MDSAP WG/N23 FINAL:2015 : Software as s Medical Device (SaMD): Application of Quality Management System
  • IMRDF/MDSAP WG/N29 FINAL:2015 : Clarification of the Term ‘Legal Entity’ for MDSAP Recognition Purposes
  • IMRDF/NCAR WG/N30 FINAL:2015 : Medical Devices: Post-Market Surveillance: IMRDF National Competent Authority Report (NCAR) Pilot Plan
  • IMRDF/NCAR WG/N31 FINAL:2015 : Medical Devices: Post Market Surveillance: National Competent Authority Report (NCAR) Pilot Plan; Implementing Material
  • IMRDF/RPS WG/N32 FINAL:2015 : Strategic Assessment of Electronic Submission Messaging Formats
  • IMRDF/MC/N34 FINAL:2015 : Statement regarding Use of ISO 14971:2007 ‘Medical devices – Application of risk management to medical devices’
  • IMRDF/MC/N35 FINAL:2015 : Statement regarding Use of IEC 62304:2006 ‘Medical device software – Software life cycle processes’
  • IMRDF/MC/N36 FINAL:2015 : Statement regarding Use of IEC 60601-1 ‘Medical electrical equipment – Part 1: General requirements for basic safety and essential performance’
  • IMRDF/MC/N37 FINAL:2015 : Statement regarding Use of ISO 10993-1:2009 ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’
  • IMRDF/MC/N38 FINAL:2015 : Statement regarding Use of ISO 11137-1:2006 ‘Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.