The European Medical Device Regulation (EU) 2017/745 (MDR) is a new set of regulations that governs the development, production and distribution of medical devices in Europe. It replaces the existing Medical Device Directive (93/42/EEC) (MDD), close to being 30 years old.
The MDR brings more uniformity within the EU and places more emphasis on safety and traceability. Some of the key changes include a more rigorous post-market surveillance, more stringent documentation, and a systematic clinical evaluation of Class IIa medical devices (including our blood bank refrigerators, plasma storage freezers, plasma contact shock freezers, and ultra-low freezers).
Back in January 2020, B Medical Systems became the first company worldwide in the industry of medical refrigeration and vaccine cold chain to obtain the new European Medical Device Regulation certification, adding an extra layer of quality assurance for its equipment.
This FAQ answers some of the most frequently asked questions related to the changes brought by the regulation, and its impact on manufacturers, distributors and European customers.