In the waves of MDR – has the medtech industry drowned in documentation?
In 2017, the well-known EU regulation on medical devices, or MDR (Medical Device Regulation) as it is more commonly called, was published within medtech. A set of rules that was set up to gain greater control over the safety and performance of products used in healthcare. But the regulation came with a three-year transition period, and did not enter into force until May 2021. And that with emphasis.