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Image: a book with the logo of the EU; Copyright: panthermedia.net/Boris Zerwann

Special May 2019

The new MDR and its implementation

The new Medical Device Regulation of the EU should bring more patient safety. The medical technology manufacturers also think that is good. But so far, they are rather annoyed by the sluggish implementation and unclear answers from Brussels. Find out more in our Special!

The new European Union Medical Device Regulation
Image: Woman hands hold a blackboard in chalk: New regulations; Copyright: panthermedia.net / Randolf Berold
Since May 25, 2017, the EU’s Medical Device Regulation (MDR) has repealed the previous Medical Devices Directive [93/42/EEC] (MDD) and Active Implantable Medical Devices Directive [90/385/EEC] (AIMD). At the end of the three-year transition period, the Regulation will fully come into force on May 26, 2020. At that point, all medical devices must be recertified to meet the requirements of the MDR.
Read the article here

Medical Device Regulation: "We see many problems with the current timeline"
Image: Woman with dark hair is sitting at a desk looking anxiously at a busy schedule; Copyright: panthermedia.net / Andriy Popov
Improved patient safety. That’s the ultimate goal of the new EU Medical Device Regulation (MDR), which was published in 2017. Starting May 2020, it will apply to all medical devices in the EU. However, a growing number of people predict that this will be difficult to implement.
Read the interview with Hans-Peter Bursig here
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