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

The purpose of this IMDRF guidance is to harmonize the documentation and procedures that are 60 used to assess whether a medical device conforms to the regulations that apply in each  jurisdiction. The worldwide adoption of  fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to the manufacturer, user, patient or consumer, and to Regulatory  Authorities. Eliminating differences between jurisdictions decreases the cost of gaining  regulatory compliance and allows patients earlier access to new technologies and treatments.

DOWNLOAD