An EU MDR Roadmap for eClinical Technology Users
The EU Medical Device Regulation (MDR) is just around the corner. With eClinical technology now all but standard in clinical data management, it’s a smart idea for medical device researchers to consider the relationship between MDR and the EDC, ePRO, and other platforms used in medtech studies.
Here are a few things to think about when evaluating whether your technology is equipped to help you adapt to this landmark regulation in the medical device industry.
Does your technology help you protect patient safety?
MDR is driven largely by growing consensus – both among regulators and the public – that the medical device industry is in need of higher safety standards. Your eClinical platform should help you meet those standards. Look for features like:
- Real-time alerts – MDR will require much faster reporting of adverse events. And an EDC, or an eSource platform for direct data capture (DDC), that alerts you to safety signals in real time will be a key resource for meeting this requirement.
- Edit checks – Any EDC software fit for today’s clinical trials will enable you to set parameters that flag missing or out-of-range data in real time, protecting data quality and ensuring you have the full, accurate view of how your product affects patients.
- Granular reporting – A robust set of reports can give you full visibility into your data, site performance, and more, accelerating the monitoring process and enabling you to discover safety signals that edit checks may have missed.
What about the patient experience in your medical device trials?
Another major aim of MDR is to ensure medical devices provide more value and a better experience to patients. There’s no reason this can’t start with clinical trials. Make sure your technology enables you to:
- Give the patient a voice – Electronic patient-reported outcomes (ePRO) platforms empower patients to communicate their own experience in their own words – even from the comfort of their own homes via email.
- Keep the patient informed – MDR will require companies to offer electronic instructions for use (eIFU). In clinical trials, an eConsent platform achieves many of the same goals as eIFUs: ensuring comprehension through graphics and videos, localizing forms, etc.
- Stay connected to the patient – As eClinical technology goes mobile, clinicians can collect data right at the patient’s bedside, or in the patient’s home, using tablet-based DDC platforms that allow for offline data capture.
Can you count on a return on your investment after EU MDR?
With new classifications and an expansion of the definition of “medical device,” many companies will find themselves needing to conduct more clinical trials. And scaling up infrastructure to meet the requirements of MDR will not always be easy. That’s why it’s crucial for your eClinical technology to help you blunt these new costs through:
- Quick startup – Your platform should be intuitive and come with the onboarding support you need, so you can get up and running quickly and avoid costly delays.
- Reducing vendor reliance – If your EDC can empower you to build studies with no coding, you can avoid the cost and delays of managing programming staff and other professional services.
- A-la carte pricing – Medical device studies often don’t need the eClinical bells and whistles that a large Phase III pharma study might. Avoid any technology platform that charges for modules you don’t need.
MDR represents a seismic regulatory shift for the medical device industry, and your technology plays a big role in your readiness to adapt. The regulation will be here before we know it. Will you be ready?