The deadline for compliance with the European Union Medical Device Regulation (EU MDR) is quickly approaching. Any medical device manufacturer planning to continue selling devices in the EU needs to be certified under MDR by May 2020–less than nine months away.
Thus far, only two devices have been certified under MDR–one Class IIa (reclassified under MDR) and one Class III. With only four Notified Bodies available to certify devices under MDR, and certification timelines taking six to nine months, speculation is circulating about the limited number of devices that can be feasibly certified within the remaining timeline. It will also be interesting to see if the U.S. will be granted its requested deadline extension.
The list of regulatory requirements under MDR is long. Medical device manufacturers will experience some level of change related to technical documentation and quality system requirements, classification status, lifecycle reporting, and more. Certification activities that once took days may now take months, or even years.
Beyond dissecting the specifics and nuances of MDR, med devices companies (and those involved in the industry) should also take a step back and read between the lines to consider MDR’s short- and long-term ramifications for the medical device industry:
- MDR is a clear signal that medical device regulations are here, they’re extensive, and this is just the beginning. As we look beyond May 2020, we can anticipate that more (or revised) regulations will be implemented as the med device industry continues to evolve and change. In the U.S. specifically, we anticipate that medical devices will soon be regulated at a level closer to pharmaceuticals due to several medical device-related deaths and injuries highlighted by the media over the past year.
- Compliance is critical to the entire medical device lifecycle. Instead of siloed compliance activities as part of discrete stages within the product life cycle, medical device companies will need to adopt a compliance-focused mindset that permeates every business division and operation. By introducing compliance into every device conversation, manufacturers will be better-positioned to handle compliance and regulation changes moving forward. That being said, the more automated compliance can be to reduce risk, the better. Companies should reconsider their internal processes and identify which compliance-related activities can be automated or streamlined. For example, automating compliance activities within your promotional review workflow is one strategy for maximizing time and resources.
- Embodying innovation is more important than ever. Medical device companies should also take a cue from one of the main intentions behind MDR: to promote a faster rate of innovation. Innovation can mean many things, but embodying innovation through products and processes sends a signal to the market and consumers that innovation is a priority–both in what med device companies are producing to advance patient care, and how they are producing it.
As medical device manufacturers work toward EU MDR compliance, consider: What can we do now to prepare for future changes? Do our internal processes well-position us to secure and maintain MDR compliance? Is our business communicating our focus on innovation, through the products we use and the processes we follow? Reading between the lines of EU MDR may be exactly what med device companies need to prepare for the next wave of regulations and stay ahead of the ever-changing compliance curve.
Vodori creates simple, innovative software for the life science industry–including medical device companies. Pepper Flow Commercial and Pepper Flow Digital Review are just two products in our robust product suite that help life science companies improve speed to market, mitigate compliance risk, and improve team collaboration.