(10/2020) The software company Climedo Health GmbH in Munich asked around 100 companies about the true costs of the EU Medical Device Regulation (MDR) by the end of August 2020. Research was carried out into how much time, money and human resources companies spend. In addition, the participants were asked about clinical data collection and data collection for market surveillance. Conclusion: Half of all companies surveyed, 77 percent of which are medical device manufacturers, believe that meeting the new requirements devours more than 5 percent of their annual turnover.
Of the 101 companies surveyed, 77 percent were manufacturers, mostly from small and medium-sized companies. The rest were also dealers, consultants, suppliers, etc. Most manufacturers have class I to IIb products in their portfolio. 22 percent are already certified according to the MDR / IVDR. When asked about the additional working time that is personally invested for the MDR per week, 55 percent of the manufacturer representatives answered "over five hours". 67 percent have hired at least one new employee because of the MDR or are planning to do so. When asked "What activities do you spend the most time on?", 68 percent responded with "Understanding of the new requirements". It is followed closely by “Clinical Assessments” and “PMS and PMCF Activities”. Note d. MTD-Red .: PMS stands for Post-Market Surveillance (surveillance after placing on the market) and PMCF for Post-Market Clinical Follow-up (clinical follow-up). With 75 percent positive responses, it's clear that most of the money goes into clinical reviews and clinical trials. This is followed by PMS and PMCF activities, an understanding of the new requirements, labeling and training measures. 48 percent of those surveyed assume that the MDR will cost their company more than 5 percent of annual sales. 33 percent of those surveyed assume costs between 1 and 5 percent, 19 percent expect costs below 1 percent. To collect PMCF-related clinical data, 69 percent of those surveyed use Excel, closely followed by paper with 47 percent. Only 11 percent use an EDC solution. Many use a combination. 83 percent invest more than a tenth of their time spent on clinical studies and PMCF in documentation and data management, and 55 percent spend more than five hours per user familiarizing themselves with a PMCF study. 45 percent spend more than an hour a week communicating with stakeholders in their PMCF study. 51 percent of those surveyed have no automated PMCF processes. However, the automation is also very low for the remaining part. Climedo therefore recommends digital solutions for automating processes.
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