We’re at the cusp of a new era for medical device research regulations. Next year, the monumental new Medical Device Regulations (MDR) will take effect in the EU market – with the new In-Vitro Diagnostic Devices Regulation (IVDR) following just 2 years after. The reasons behind these stricter regulations are commendable. MDR seeks to:
• Increase standards for device quality and safety.
• Provide patients greater value and transparency.
• Take greater advantage of the technological advancements from the past 20 years.
What will be necessary to meet new MDR regulations? Data – and more of it than ever. Along with the aims of MDR come a clinical trial data management complexity that might cause some growing pains for the medical device industry.
For us at Medrio, the goals of MDR fall in line with the core values of clinical research. The industry’s central aim is to provide life-saving products and treatments to those who need them, and a robust regulatory landscape helps ensure that. As far as data management goes, the design of our eClinical tools facilitates this task and helps researchers stay compliant with ever-shifting regulations. We know that clinical researchers and the organizations that support them can grow with MDR to do their best work yet.
We see this transitional period as an opportunity: as device companies looking to do business in Europe race to meet new compliance standards, it’s a pivotal moment to improve processes, enhance efficiency, and make it easier over the long run to develop more high-quality, innovative devices. Let’s take a closer look at MDR challenges and what we can expect in the future of clinical research regulations:
Huge shifts and real-time transparency
A key change to MDR’s more stringent approach is that it shifts both responsibility and liability for product safety and quality to manufacturers, rather than regulatory agencies. Since MDR regulations will be legally enforceable in all EU countries, device companies could face big problems if their products fall short of meeting new regulatory requirements. Companies will need to:
• Maintain solid ongoing documentation of compliance – especially additional post-market surveillance. This includes detailed and regularly updated summaries of safety and clinical performance information, patient and general practitioner feedback, and potentially data from patient forums and social media platforms.
• Utilize electronic instructions for use (eIFUs). These aim to enhance patient safety by providing users with product information updated in real time in the user’s preferred language. They need to be accessible via mobile devices and include video and audio files for easy patient comprehension.
Looking beyond MDR
While MDR is what the industry is currently talking about, more rigorous regulations are expected worldwide in the near future. Take a look at this:
• In December 2018, the FDA announced plans to overhaul US medical device regulations. The FDA has already taken steps to increase post-market data collection and surveillance of medical devices.1
• Countries in Asia-Pacific (APAC) are expected to come out with new regulations soon, with an even shorter compliance grace period than MDR.1
• Influential organizations like the International Medical Device Regulators Forum (IMDRF) have also expressed interest and support for MDR, which could lead to more variations of it outside of Europe.
Technology and compliance demands
To help researchers ensure compliance with MDR, companies have already begun developing innovative tools. One organization has created a barcode technology for eIFU compliance. This enables medical device manufacturers to build mobile scanning applications that allow device users to quickly access eIFUs in the language of their preference from their smartphones.
From mobile devices to eIFUs to eClinical tools, MDR means technology will be fully integrated into healthcare and clinical research – and there’s no looking back. Choosing the right tools that best support specific research goals is, now more than ever, a central concern for organizational success. For us at Medrio, we’ll keep doing our part to facilitate compliance and data management whether it’s with our tools for direct data capture, EDC, ePRO or eConsent. And while adapting to stricter regulations like MDR may cause some headaches at the beginning, the companies who adapt fastest and deliver the best products to patients in need will be the winners in the future of public health.
1 FDA News (2018) EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements, Digital version, ISBN: 978-1-60430-063-5