Regulations and Directives
European Medical Device Regulations and Directives
- Medical Device Directive 93/42/EEC
- Medical Device Regulation EU 2017/745
- In vitro Diagnostic Device (IVD) Directive 98/79/EC
- In vitro Diagnostic Device (IVD) Regulation EU 2017/746
US Medical Device Regulations
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
FDA Recognized Consensus Standards
IMDRF
IMDRF guidances
- SaMD WG/N10FINAL:2013, Software as a Medical Device (SaMD): Key Definitions
- SaMD WG/N12FINAL:2014, “Software as a Medical Device”: Possible Framework for Risk Categorization and Corresponding Considerations
- SaMD WG/N23 FINAL: 2015, Software as a Medical Device (SaMD): Application of Quality Management System
- SaMD WG (PD1)/N41R3: 2016, Software as a Medical Device (SaMD): Clinical Evaluation
- RPS WG/N13FINAL:2014, In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)
Training Presentations