A proposal to delay the EU's MDR gets approved
A vote in the European Parliament has decisively approved a delay to full implementation of the EU's MDR by one year, allowing the medical device industry to prioritise its Covid-19 response efforts.
Expert analysis on Medical Device Regulation
-
-
Out of the woods? EU regulators may delay MDR enforcement
A delay of the MDR would be welcome news for many, but what would a delay mean in practice? To what extent can preparations for EU MDR be put on ice?
-
The new MDR compliance challenge
Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.
-
Sources of Real World Evidence
There are multiple ways to generate RWE. At Mantra Systems our objective is to make sure that our clients choose the method of real world data harvesting that is right for them.