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  • IMDRF Consultation Feedback - AI/ML WG - Technical Framework for Artificial Intelligence Life Cycle Management

    The International Medical Device Regulators Forum (IMDRF) recognizes the growing role of artificial intelligence (AI) technologies in medical devices and has continued its efforts to establish a harmonized approach for the oversight, evaluation, and use of AI-enabled medical devices. Building on its previous work, including the publication IMDRF/AIML WG (Artificial Intelligence/Machine Learning-enabled Working Group)/N88 FINAL:2025: Good Machine Learning Practice (GMLP) for Medical Device... More
    Opened 10 April 2026

  • IMDRF Consultation Feedback - CE IVD WG - Definitions and Principles of Performance Evaluation

    This document supersedes earlier documents produced under the Global Harmonization Task Force (GHTF): GHTF/SG5/N6:2012 Clinical Evidence for IVD medical devices – Key Definitions and Concepts and GHTF/SG5/N7:2012 Clinical Evidence for medical devices – Scientific Validity Determination and Performance Evaluation. It outlines the concepts, principles and terminology for clinical evidence related to in vitro diagnostic (IVD) medical devices, taking into account the differences... More
    Opened 4 March 2026

  • IMDRF Consultation Feedback - Essential Principles and Content of PCCP (N90 - SaMD WG)

    This document serves to facilitate international convergence and harmonize approaches across 90 jurisdictions by describing essential principles for Predetermined Change Control Plans (PCCPs). The IMDRF Software as a Medical Device (SaMD) Working Group seeks your feedback on the draft document through this consultation which is open until 8 December 2025. This online feedback form is designed for a maximum of 10 proposed changes. Should you wish to suggest more than 10 changes you... More
    Closed 8 December 2025

  • Adverse Events Terminology - Change Request Form

    The IMDRF Adverse Event Terminology is always open for Change Requests. The cut-off date for inclusion in the next release is 1 September. The Change Requests will then be reviewed by the AET IMDRF Working Group, and the updated terminology and outcome of Change Requests will be published in March. Below are the IMDRF AE terms: Annex A: Medical Device Problem Annex B: Cause Investigation - Type of Investigation Annex C: Cause Investigation... More
    Opened 1 September 2025

  • MDSAP Regulatory Authority Council (RAC) Member Application Form

    Please complete this digital form to apply for MDSAP Regulatory Authority Council (RAC) Membership to the Medical Device Single Audit Program. MDSAP Membership is only available to Regulatory Authorities exercising a legal legal right to control the use or sale of medical devices within its jurisdiction, and that may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements. To be eligible for membership as an MDSAP RAC... More
    Created 1 April 2025

  • MDSAP Official Observer Application Form

    Please complete this digital form to apply for Official Observer Membership to the Medical Device Single Audit Program (MDSAP). MDSAP Membership is only available to Regulatory Authorities exercising a legal legal right to control the use or sale of medical devices within its jurisdiction, and that may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements. To be eligible for membership as an Official Observer, an... More
    Created 1 April 2025

  • MDSAP Affiliate Membership Application Form

    Please complete this digital form to apply for Affiliate Membership to the Medical Device Single Audit Program (MDSAP). MDSAP Membership is only available to Regulatory Authorities exercising a legal legal right to control the use or sale of medical devices within its jurisdiction, and that may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements. To be eligible for Affiliate Membership, an organization must meet the... More
    Created 6 February 2025

  • IMDRF Membership Application Form - Management Committee Member

    Please use this digital form to submit your application to join the IMDRF as a Management Committee Member. Applications must be submitted at least two months before an IMDRF Management Committee face-to-face Closed Session, which are usually held two times each year, generally in March and September. Please ensure you have considered the IMDRF Standard Operating Procedures applying to Management Committee Membership prior to commencing your application. (Right click to open the... More
    Created 5 December 2024

  • IMDRF Membership Application Form - Affiliate Membership

    Please use this digital form to submit your application to join the IMDRF as a Affiliate Member. Applications must be submitted at least two months before an IMDRF Management Committee face-to-face Closed Session, which are usually held two times each year, generally in March and September. Please ensure you have considered the IMDRF Standard Operating Procedures applying to Affiliate Membership prior to commencing your application. (Right click to open the links below in a new... More
    Created 5 December 2024

  • IMDRF Membership Application Form - Regional Harmonization Initiative

    Please use this digital form to submit your application to join the IMDRF as a Regional Harmonization Initiative (RHI). Applications must be submitted at least two months before an IMDRF Management Committee face-to-face Closed Session, which are usually held two times each year, generally in March and September. Please ensure you have considered the IMDRF Standard Operating Procedures applying to RHI Membership prior to commencing your application. (Right click to open the links... More
    Created 5 December 2024
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