Good Regulatory Review Practices
The charter of the Good Regulator Review Practices (GRRP) working group is to develop guidance that establishes good regulatory review practices for regulatory authorities and/or their conformity assessment bodies.
The Review Practices (GRRP) working group aims to improve the effectiveness and efficiency of pre-market review. The GRRP working group has produced documents to support pre-market review including those listed below.
Essential Principles of Safety and Performance Workshop
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, 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 was meant to serve as an introductory overview of the topics upon which future IMDRF training sessions may expand.
The recordings and materials shared during the sessions are available from the Medical Device Convergence Project (MDRC) website, IMDRF Training page.