DO PATIENTS EVEN NEED THE MDR?
MDR’S sole goal and purpose are to update the EU rules regarding the safety and performance of medical devices to ensure that patients get the best possible technology with the absolute minimum risk.
MDR plans to achieve this for the patients through some key changes to the old rules that were rooted in the 1990s. MDR implemented;
1) A very strict control mechanism especially for high-risk devices through a pre-market scrutiny mechanism involving experts other than Notified Bodies.
2) A requirement for increased quality of clinical data.
3) A transparency system to force manufacturers to provide safety and performance data on their devices in the public domain through European Database on Medical Devices (EUDAMED).
4) A new device traceability system that allows the unique identification of the product through the supply chain.
5) An improved cooperation system for member countries to increase data sharing regarding vigilance and market surveillance.
6) A financial compensation mechanism for patients that are harmed by medical devices. MDR is an inevitable update to the outdated rules that are no longer valid due to rapidly evolving technological advances in medical devices for patients to have access to the safest medical devices with the best clinical performance.