Closed consultations

A review of the NCAR system

Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form

8 December 2014

Adverse Event Terminology

IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Annex А (Edition 3), G

10 September 2019

IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes

12 October 2018

IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes - Annex B

31 May 2017

IMDRF Terminologies for Categorized Adverse Event Reporting: terms, terminology and codes

2 December 2016

Artificial Intelligence Medical Devices

Machine Learning-enabled Medical Devices - A subset of Artificial Intelligence-enabled Medical Devices: Key Terms and Definitions

29 November 2021

Good machine learning practice for medical device development - Guiding Principles

30 August 2024

Good Regulatory Review Practices

Marketing Review Report Work Instruction

8 July 2022

Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews

19 April 2021

Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

26 May 2020

Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies

9 May 2020

Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

3 October 2019

Principles of Labeling for Medical Devices and IVD Medical Devices

12 September 2018

Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices

18 April 2018

Competence, Training and Conduct Requirements for Regulatory Reviewers

14 October 2016

IMDRF Management Committee

Guiding Principles to Support Medical Device Health Equity (N79)

28 August 2023

IMDRF recognized standards

Optimizing Standards for Regulatory Use

24 May 2018

Integrating patient registries and innovative tools for enhanced medical device evaluation and tracking

Tools for Assessing the Usability of Registries in Support of Regulatory Decision Making

1 December 2017

Methodological Principles in the Use of International Medical Device Registry Data

2 December 2016

Patient Registry: Essential Principles

16 January 2016

Medical Device Clinical Evaluation

Proposed update to document on Post-Market Clinical Follow-Up Studies

11 December 2020

Proposed update to Clinical Evaluation documents

5 June 2019

Medical Device Cybersecurity Guide

Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

30 August 2022

Principles and Practices for the Cybersecurity of Legacy Medical Devices

3 July 2022

IMDRF Principles and Practices for Medical Device Cybersecurity

2 December 2019

Medical device single audit program (MDSAP)

MDSAP - Medical Device Regulatory Audit Reports

1 June 2015

MDSAP - Guidance on Regulatory Authority Assessment Methods of Auditing Organization's Processes

1 June 2015

MDSAP Assessment Outcomes and Recognition/Re-recognition Decision by Regulatory Authorities

31 May 2014

Regulatory Assessment Program and Assessment Strategy utilizing for the recognition and monitoring of medical device auditing organizations

30 August 2013

Assessor competency and training requirements for Regulatory Authorities undertaking assessments of auditing organizations

30 August 2013

Recognition and monitoring of organizations undertaking audits of medical device manufacturers

14 June 2013

Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers

14 June 2013

Recognition Criteria for Medical Device Auditing Organizations

14 December 2012

Personalized Medical Devices (PMD)

Personalized Medical Devices Regulatory Pathways

28 November 2022

Personalized Medical Devices Production Verification and Validation

28 December 2022

Personalized Medical Devices - Regulatory Pathways

24 July 2019

Definitions for Personalized Medical Devices

24 May 2018

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

25 July 2020

Regulated Product Submission

In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)

30 May 2023

Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC)

30 May 2023

RPS Table of Contents Pilot

20 March 2018

RPS - Common Data Elements for Medical Device Identification

15 September 2015

Request for expressions of Interest to participate in the IMDRF TOC pilot plan

21 August 2015

Regulated Product Submission - Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions

1 June 2015

In-Vitro Diagnostics Market Authorization Table of Contents

17 January 2014

Regulated product submission (RPS) Table of contents

21 June 2013

Software as a Medical Device

Medical Device Software: Considerations for Device and Risk Characterization

2 May 2024

Software as a Medical Device (SaMD)

Software as a Medical Device (SaMD): Clinical Evaluation

13 December 2016

Software as a Medical Device (SaMD): online survey now open

3 August 2015

Software as a Medical Device (SaMD): Application of Quality Management System

1 June 2015

Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls

31 May 2014

Standalone Software: Key Definitions

30 August 2013

Unique Device Identification (UDI) Application Guide

Unique Device Identification system (UDI System)

12 October 2018

UDI System for Medical Devices

31 August 2013

Closed consultations

A review of the NCAR system

Adverse Event Terminology

Artificial Intelligence Medical Devices

Good Regulatory Review Practices

IMDRF Management Committee

IMDRF recognized standards

Integrating patient registries and innovative tools for enhanced medical device evaluation and tracking

Medical Device Clinical Evaluation

Medical Device Cybersecurity Guide

Medical device single audit program (MDSAP)

Personalized Medical Devices (PMD)

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Regulated Product Submission

Software as a Medical Device

Software as a Medical Device (SaMD)

Unique Device Identification (UDI) Application Guide

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