The results of the survey by Munich-based software company, Climedo Health, which investigated the true costs associated with the European Medical Device Regulation (EU MDR), have been released.
The survey was completed by 101 companies from Europe between July and August 2020. The majority (95%) of respondents were from German-speaking countries and more than three quarters (77%) of them were medical device manufacturers. All device risk classes were represented in survey respondents.
Key findings:
- 55% of participants invest more than five 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 the MDR.
- Most time is spent on "understanding the new requirements" (named by 68%), followed by "clinical evaluation and clinical studies" (63%).
- Most money is spent on "clinical evaluation and clinical studies" (named by 75%), followed by PMS and PMCF activities (52%).
- 48% believe that the EU MDR will cost more than 5% of their annual turnover (an increase from Climedo's survey from the spring where it was only 32%).
Additionally, specific questions were asked about clinical data collection in the post-market phase, which will play an important role for the EU MDR:
- 69% use Excel, 47% use paper and only 11% use an EDC solution for clinical data management; 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 five hours per user on onboarding for a PMCF study.
- 45% spend more than one hour per week on stakeholder communication.
- 51% do not yet have automated PMCF processes; only 5% have automated more than 10% of these processes.
Veronika Schweighart, co-founder and COO of Climedo Health, commented: "The fact that the EU MDR is an expensive matter doesn't come as a surprise.
"These survey results show that a particularly large amount of time and money flows into clinical studies and PMS activities. And this is precisely where there is still a lot of potential for digitalisation that manufacturers could be exploiting.
“Paper-based systems, which are still 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.“
Climedo Health states that participants who left their email address and who work for a medical device manufacturer will receive an individual assessment of how much their company could be saving by using a digital solution.
The survey results can be downloaded here.