Info
26 May 2021
by eub2
-- last modified 26 May 2021
As of 26 May, new EU rules on medical devices (MDR) enter into application, establishing a modern and more robust regulatory framework to protect public health and patient safety.
Advertisement
1. Why is there a need for new rules on medical devices?
The EU rules on the safety and performance of medical devices were
created in the 1990s. To reflect the substantial technological and
scientific progress in this sector over the last 20 years, the
Commission has proposed to update the rules to improve the safety of
medical devices, with a view to modernise the sector and to consolidate