SARACA Medical Technologies on New European Medical Device Regulation: changes, challenges and implementation

The European Medical Device Regulation 2017/745 (MDR) passed the European Parliament on April 5, 2017 and will be operational starting in May 26, 2020. The regulation has significant economic impact on manufacturers,due to the cost of implementation of new regulations for new devices and ensuring that legacy products meet the new requirements. There will be no grandfathering of existing products from the current EU Medical Devices Directive (MDD). The MDR also strongly affects distributors and importers. The aim of these new regulations is to ensure that products are effective and safe as well as can be freely and fairly traded throughout the Europe. The existing rules that currently govern medical devices date back to the 1990s and have not kept pace with the significant innovations in technology and science.