Breadcrumb Home Consultations Closed consultations 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 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 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 - Guidance on Regulatory Authority Assessment Methods of Auditing Organization's Processes 1 June 2015 MDSAP - Medical Device Regulatory Audit Reports 1 June 2015 MDSAP Assessment Outcomes and Recognition/Re-recognition Decision by Regulatory Authorities 31 May 2014 Assessor competency and training requirements for Regulatory Authorities undertaking assessments of auditing organizations 30 August 2013 Regulatory Assessment Program and Assessment Strategy utilizing for the recognition and monitoring of medical device auditing organizations 30 August 2013 Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers 14 June 2013 Recognition and monitoring of 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 Production Verification and Validation 28 December 2022 Personalized Medical Devices Regulatory Pathways 28 November 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 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification 25 July 2020 Regulated Product Submission 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 (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
Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form 8 December 2014
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
Machine Learning-enabled Medical Devices - A subset of Artificial Intelligence-enabled Medical Devices: Key Terms and Definitions 29 November 2021
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
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices 18 April 2018
Tools for Assessing the Usability of Registries in Support of Regulatory Decision Making 1 December 2017
Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity 30 August 2022
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
Assessor competency and training requirements for Regulatory Authorities undertaking assessments of auditing organizations 30 August 2013
Regulatory Assessment Program and Assessment Strategy utilizing for the recognition and monitoring of medical device auditing organizations 30 August 2013
Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers 14 June 2013
Recognition and monitoring of organizations undertaking audits of medical device manufacturers 14 June 2013
Regulated Product Submission - Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions 1 June 2015
Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls 31 May 2014