Transition to MDR

The aim of Medical Devices Regulation 2017/745 (MDR) revision is to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation. Although the MDR took effect in May 2021, it is providing the industry with a soft transition period from the […]

Breakthrough Devices Program

What is a Breakthrough designation? The FDA Breakthrough Device Designation is a formal identification by the US FDA that a device in development should be expedited for patient access because it has a reasonable chance of providing more effective treatment than the standard of care for the treatment or diagnosis of life-threatening or irreversibly debilitating […]