While the majority of the content of these updated regulations focuses on regulatory aspects and legal requirements, there are also some updated requirements regarding device vigilance. Device vigilance is becoming increasingly more prominent, as more medical devices enter the market and their complexity increases.
Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR) were adopted in April 2017, with an expected transition period of four years. These regulations provide an updated legal framework for medical devices in Europe, including new responsibilities for national competent authorities (NCAs) and the European Medicines Agency (EMA). As of 23rd April 2020, the European Parliament and Council of the EU adopted a proposal to extend the transition period of the MDR by one year, until 26th May 2021, due to the current coronavirus pandemic. IVDR is expected to become fully adopted in 2022.
This Whitepaper will discuss the safety or vigilance implications of these new regulations.