November 25, 2019. Read the latest CEO post on 6 months left until MDR |

With only half a year left until application, the implementation of EUDAMED delayed with 2 years, and slow progress on implementation of acts and guidances, there are calls for and rumors on extension of timelines of the EU MDR. But does that actually mean that medical device manufacturers have more time to bring their clinical evaluation in order?

Under the MDR all devices will require a Clinical Evaluation with clinical evidence “appropriate in view of the characteristics of the device and its intended purpose” including Class I devices, so manufacturers better be on top of this.