11 and 19 September 2024
Training on IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N47)
On 11 and 19 September, 2024, the International Medical Device Regulators Forum (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, 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 Training Objectives for the workshop are as follows:
- Emphasize the importance of the IMDRF Essential Principles as a foundational reference for NRA Medical Device Regulatory Frameworks – underpinning all other IMDRF documents.
- Relay how NRA prioritized use of the Essential Principles enables the establishment of the proper legal foundations for medical device rulemaking by serving as a core tool to implement Good Regulatory Practices (GRP).
- Overview how the Essential Principles as GRP promote and facilitate the use of relevant international standards and conformity assessment as core components of GRP and proper legal foundations, accelerating medical device regulatory convergence.
- Engage in a group activity applying Essential Principles to specific medical devices.
- Review a case study in the real-world application of the Essential Principles.
The recordings and materials shared during the sessions are available via the following links: