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Technical document

IMDRF/AIMD WG/N67 (Edition 1)

Machine Learning-enabled Medical Devices: Key Terms and Definitions

Technical Document: IMDRF/AIMD WG/N67

Published date

9 May 2022

Technical document

IMDRF/IVD WG/N64

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Technical document: IMDRF/IVD WG/N64FINAL:2021 (formerly GHTF/SG1/N045:2008)

Published date

21 January 2021

Technical document

IMDRF/PMD WG/N49

Definitions for Personalized Medical Devices

Technical document: IMDRF/PMD WG/N49FINAL:2018

Published date

7 November 2018

Information document

IMDRF/MC/N34

Statement regarding Use of ISO 14971:2007 "Medical devices - Application of risk management to medical devices"

Information document IMDRF/MC/N34 FINAL:2015.

Published date

2 October 2015

Information document

IMDRF/NCAR WG/N30

Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan

Information document IMDRF/NCAR WG/N30FINAL:2015.

Published date

2 October 2015

Information document

IMDRF/MC/N38

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"

Information document IMDRF/MC/N38 FINAL:2015.

Published date

2 October 2015

Information document

IMDRF/NCAR WG/N31

Medical Devices: Post Market Surveillance: National Competent Authority Report (NCAR) Pilot Plan; Implementing Material

Information document IMDRF/NCAR WG/N31FINAL:2015.

Published date

2 October 2015

Information document

IMDRF/MC/N37

Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

Information document IMDRF/MC/N37 FINAL:2015.

Published date

2 October 2015

Information document

IMDRF/MC/N25

Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for human subjects – Good clinical practice"

Information document IMDRF/MC/N25 FINAL:2015.

Published date

7 April 2015

Technical document

IMDRF/UDI WG/N7

UDI Guidance: Unique Device Identification (UDI) of Medical Devices

Technical document: IMDRF/UDI WG/N7FINAL:2013

Published date

18 December 2013

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Machine Learning-enabled Medical Devices: Key Terms and Definitions

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Definitions for Personalized Medical Devices

Statement regarding Use of ISO 14971:2007 "Medical devices - Application of risk management to medical devices"

Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan

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"

Medical Devices: Post Market Surveillance: National Competent Authority Report (NCAR) Pilot Plan; Implementing Material

Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for human subjects – Good clinical practice"

UDI Guidance: Unique Device Identification (UDI) of Medical Devices

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