With the publication of the Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR) on May the 25th, 2017, these new PMS requirements will now become mandatory for all Medical Device Manufactures from May 26, 2020 on.
The European Medical Device Regulation mandates structured PMS processes and analytical methods to systematically collect, analyze and evaluate clinical safety and performance data throughout the life-time of the device.
It is advised to carefully review the current PMS data collection processes and evaluation methods
to ensure the outcomes meet the raised reporting standards in content and format supporting
continued market access in Europe. Are you prepared?
Our regulatory expert Stephan Buttron takes a deeper look at some of the top things you need to be prepared for in time for the May 2020 deadline.
Download the full article here.