On March 6 and 7th 2019 we had the official kick-off of our Horizon 2020 project MDOT (grant 814656, www.mdot.eu) at the Fraunhofer Institute ITEM in Hannover. The project focusses on new methods to test and certify medical devices to meet the upcoming medical device regulation (MDR) in Europe.
The Medical Device Regulation (MDR) introduces a new level of (i) patient safety, (ii) product reliability and (iii) enhanced clinical performance criteria within the conformity assessment process. This places a heavy burden on medical device innovation in Europe, since the clinical and reporting/surveillance requirements will greatly increase. It is expected that SMEs are particularly affected by MDR’s extensive documentation and report obligations and new clinical testing requirements. To support SMEs and simultaneously enhance quality and regulatory compliance, the Medical Device Obligations Taskforce (MDOT) was established, an exchange network enabling automated conformity assessment proceedings and the transfer of technical and clinical performance data across Europe. The overall aim of MDOT is the prevention of a massive loss of innovation and economic strength in the European medical device industry by provision of expertise and data by a consortium of medical device stakeholders.