IMDRF Guidance Addresses Essential Principles for Medical Devices, IVDs
Posted 22 January 2018 | By
The International Medical Device Regulators Forum (IMDRF) last week launched a public consultation for its proposed guidance on the essential principles of safety and performance of medical devices and in vitro diagnostics (IVDs).
The consultation is set to run until 18 April 2018, and once adopted, the new guidance will supersede an earlier guidance issued by the now defunct Global Harmonization Task Force (GHTF) in 2012.
IMDRF says the goal of the proposed guidance is to harmonize the documentation and procedures required to evaluate medical devices and IVDs for conformity in various jurisdictions around the world to reduce the amount of time and cost of bringing devices to market.
"Essential principles of safety and performance provide broad, high-level, criteria for design, production, and postproduction (including postmarket surveillance) throughout the life-cycle of all medical devices and IVD medical devices," IMDRF writes.
Specifically, the proposed guidance sets out expectations for the essential principles for the design, manufacturing, clinical evaluation and labeling of devices, and makes additional recommendations for devices and IVDs that use software, emit radiation or incorporate biological materials.
The proposed guidance also references international guidances and standards developed by IMDRF, GHTF and other standards bodies such as the International Organization for Standardization (ISO), including a list of harmonized definitions related to devices and IVDs.