Survey: EU MDR will cost many manufacturers more than 5% of annual turnover

Survey: EU MDR will cost many manufacturers more than 5% of annual turnover


August 27, 2020

Munich, Thursday, August 27 2020 — Munich-based software company Climedo Health has published the survey results on the true costs of EU MDR. The evaluation shows that the regulation requires considerable resources on the part of the manufacturers. At the same time, most of them are not yet exploiting the potential of EDC solutions and automated processes for their clinical data collection.


The aim of the MDR survey, which was conducted by Climedo Health between July and August 2020, was to explore the true cost of EU MDR for businesses. A total of 101 companies from Europe took part in the survey, the majority (95%) from German-speaking countries and more than three quarters (77%) of them medical device manufacturers. All risk classes were represented. Here’s an overview of the most important findings: 



In addition, specific questions were asked about clinical data collection in the post-market phase, which will play an important role for EU MDR: 


„The fact that the EU MDR is and remains an expensive matter should come as no surprise”, says Veronika Schweighart, CoFounder and COO of Climedo Health. “The survey results show that, among other things, a particularly large amount of time and money goes into clinical studies and PMS activities. And this is exactly where there is still a lot of potential for digitalization that manufacturers could be exploiting. Paper-based systems, which are still being used by half of the participants, will not be able to keep up in the future due to the strict regulatory requirements for data collection. Although the switch to an EDC system requires a certain initial investment, in the long term it will save valuable time and costs and avoid unnecessary errors thanks to automation and structuring. This is the only way to ensure that medical devices are (re-)certified according to MDR and do not have to be taken off the market.“


Participants who left their email address and work for a medical device manufacturer will receive an assessment of how much their company could be saving by using a digital solution. The complete survey results can be downloaded here:


Get Survey Results


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