Small and medium-sized enterprises (SMEs) in MedTech provide over 650,000 jobs in Europe, deliver a positive trade blance of 14 Billion Euro and MedTech is the number one technology sector regarding patent applications. However, SMEs are particularly affected by the changes in regulatory affairs resulting from the Medical Device Regulation (MDR) with its extensive documentation and report obligations and new clinical testing requirements. With the increased demands and their associated complexity, a significant number of SMEs in the MedTech field are now economically and resource-wise at risk, facing a massive loss of innovation, jobs, economic strength and product diversity.
The Open Innovation Test Bed MDOT (Medical Device Obligations Taskforce) supports SMEs in their conformity assessment and simultaneously enhances quality and regulatory compliance to prevent of a massive loss of innovation and economic strength in the European medical device industry.