Here it is: The new medical device regulation (MDR)

The long awaited text for the new regulation on medical devices is published:

• (EU) 2017/745 english Version
• (EU) 2017/745 german version
• (UE) 2017/745 spanish version

It includes further strengthened requirements for manufacturers bringing the products onto the European market.

For Details see our webpage on the "THE NEW MDR"...