The EU Medical Device Regulation (2017/745), which came into full effect in May 2021, poses stringent demands on medical device manufacturers. Among other new requirements, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) will become crucial for medical device manufacturers.
Our recent survey about the true costs of the EU MDR with over 100 respondents showed that the new regulation requires a significant amount of resources on the part of manufacturers, particularly those selling high-risk devices.
More than half of our participants said that they invest more than five additional hours per week in meeting the new MDR requirements. Around two thirds said they have hired or plan to hire at least one new employee to help them cope with MDR. Almost half of the respondents said they believe the new regulation will cost their company over 5% of their annual revenue.
At the same time, however, our survey showed that most companies have yet to tap into the full potential of digital solutions for their clinical data capture, which of course plays a crucial role in the EU MDR era. For example, just 11% said they use an Electronic Data Capture (EDC) solution for managing their clinical data. Over two thirds use Excel spreadsheets and almost half use paper-based solutions; many use a combination of the latter two.
Yet, many of the clinical data capture processes which would take a long time on paper can be fully automated with an EDC system. In the event of unannounced audits, paper-based firms will struggle to retrieve specific data on time. Furthermore, the high error rate resulting from manual data entry is likely to be much more costly compared to the cost of an automated EDC system.
Using our PMCF Cost Calculator, which was developed based on empirical research, expert interview and our own customer testimonials, this Whitepaper will show you exactly how you could be saving valuable resources with the use of a digital solution for your clinical data capture, whether you're running a small or a large study. We hope you enjoy reading this paper. If you have any questions, please get in touch!
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.By digitally connecting all stakeholders (Medical Device manufacturers, Pharma companies, CROs, hospitals and patients), Climedo allows for increased performance, better cost-efficiencies - and ultimately - accelerated medical innovation. Learn more at www.climedo.com