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

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:

55% of participants invest more than 5 additional hours per week in meeting the new MDR requirements
67% have hired or plan to hire at least one new employee to help cope with MDR
Most time is spent on “understanding the new requirements” (cited by 68%), followed by “clinical evaluations and clinical studies” (63%)
Most money is spent on clinical evaluation and clinical studies (cited by 75%), followed by PMS and PMCF activities (52%)
48% believe that the EU MDR will cost more than 5% of their annual turnover (in the Climedo survey from the spring it was only 32%)

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

69% use Excel, 47% use paper and only 11% use an EDC solution; many use a combination
83% invest more than one tenth of their time spent on clinical trials and PMCFs in documentation and data management
55% spend more than 5 hours per user training for a PMCF study
45% spend more than 1 hour per week on stakeholder communication
51% do not yet have automated PMCF processes; only 5% have already automated more than 10% of these processes

„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