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

On 11 and 19 September, 2024, the IMDRF organized a two-part workshop focused on building Medical Device National Regulatory Authority (NRA) capacities and awareness of the IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2)) for current and prospective IMDRF Affiliate Members. This two-part workshop took place in conjunction with the U.S. Food and Drug Administration (USFDA) hosting of the IMDRF meetings.

The workshop was led by representatives of the NRA member bodies of the IMDRF Management Committee joined by select medical device industry representatives to provide real-world perspectives of the application and benefits of the Essential Principles as a cornerstone of effective medical device regulatory frameworks. This workshop is meant to serve as an introductory overview of the topics upon which future IMDRF training sessions may expand.

The presentations and recordings of the sessions are available from the MDRC Project and Standards Alliance website.

To navigate to the agenda, session recordings and presentation materials that comprise this training; Access Training