Survey Results: The True Cost of the EU MDR

+++ Recently featured by RAPS (Regulatory Affairs Professionals Society): "EU MDR survey: Time investment, costs, and personnel resources" (members only) +++


EU MDR considered an expensive and time-consuming matter by most medical device manufacturers

The delay of the EU-MDR until May 2021 came as a relief to most medical device manufacturers. Nevertheless, there is a lot of unrest in the MedTech market. While our survey on the status of MDR implementation in March 2020 showed that many companies were not yet prepared for the new requirements, this survey deals with the actual costs of the new regulation in companies. Among other things, we wanted to explore how much time, money and personnel are being invested in meeting the obligations. In addition, participants were asked which systems they currently use for clinical data capture, how time consuming this data management is for them and to what extent they have already automated their post-market processes.

The survey was conducted between July and August 2020. In total, just over 100 companies took part, the majority of them (77%) medical device manufacturers. For most companies, the EU MDR seems to be a very expensive and complex matter:

  • Almost half of them believe that they will invest more than 5% of their annual turnover in meeting the new requirements
  • More than two thirds have hired or plan to hire at least one new employee to cope with MDR
  • More than half invest over 5 additional hours per week in meeting commitments
  • At the same time, only 11% use an EDC solution for their data collection - an essential part of MDR - and 51% have no automated PMCF processes at all.

We hope that the results will give you new impulses. If you have any questions or comments, please feel free to contact us at


Read more via Medical Plastics News and MedTech Dive.


About Climedo Health

Climedo Health’s mission is to bring the best treatment to every patient by empowering healthcare professionals with intelligent software solutions.

Together with Europe’s leading hospitals, we have developed a cloud-based platform for cutting-edge clinical validation and post-market surveillance of medical devices and pharmaceutical products.

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