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Harmonized standards for IVD and MD

This is a non-inclusive selective list of important guidance documents.

Harmonized standards for IVD and MD :

  • CEN EN ISO 13485 Quality Management System
  • ISO 14971 Risk management
  • ISO 15189 Medical laboratories
  • ISO 14155 Clinical investigation of medical devices for human subjects- Good clinical practice
  • CEN EN 980 Symbols in medical device labeling
  • CEN EN ISO 10993 Biological evaluation of medical devices, parts 1-18
  • CENELEC EN 60601 Medical electrical equipment
  • CENELEC EN 62304 Medical Device software life-cycle software processes
  • CENELEC EN IEC 62366 Medical Devices: application of usability engineering to medical devices
  • CEN EN ISO 13612 Performance evaluation of In vitro diagnostic medical devices
  • CEN EN ISO 18113 In vitro diagnostic medical devices: Information supplied by the manufacturer (labeling) Parts I – V
  • CEN EN ISO 23640 In vitro medical devices: Evaluation of Stability of in vitro diagnostic reagents
  • CENELEC EN IEC 61010-2-101 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
  • CENELEC EN IEC 61326-2-6 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

MEDDEVs

European Commission MEDDEV guidances

  • MEDDEV 2.12.1, Rev. 7 – Guidelines on a Medical Devices Vigilance System
  • MEDDEV 2.12.2, Rev. 2 – Post Market Clinical Follow-up Studies
  • MEDDEV 2.14.1, Rev. 2 – IVD Medical Device Borderline and Classification Issues
  • MEDDEV 2.5.10, Rev. 1 – Guideline for Authorized Representatives
  • MEDDEV 2.2.4 Guidelines for Conformity Assessment IVF/ART products
  • MEDDEV   2. 4/1 Rev. 9 Medical Devices: Classification of medical devices
  • MEDDEV 2.7/1 revision 4 Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42/EEC and 90/385/EEC
  • MEDDEV 2.1/6 Guidance document Medical Devices – Scope, field of application, definition – Qualification and Classification of stand-alone software
  • MEDDEV 2.14/3 rev.1 Guidance document – In vitro diagnostic medical devices – Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices

Training Presentations