A shakeup is coming to medical device clinical research. The EU’s new Medical Device Regulation (MDR) comes into effect in May 2020 – and organizations around the world doing device trials in Europe will need to get up to speed.
On a high level, the Regulation has three big elements:
• Tighter licensing regulations
• Stricter data scrutiny on both new and existing devices
• Higher potential for competition
What else will change?
A core component of MDR is a shift in the power balance between hospital buyers and suppliers. Hospitals will have more information in their hands than ever, and device companies will be under the gun to deliver high-value products and provide greater transparency about their ongoing safety and effectiveness.
MDR will raise governance standards and lay out more legal clarity in post-market safety. But that’s not all: a central goal of MDR is to encourage new players to enter the market to fill supply gaps and increase product value.
Who’s prepared for MDR?
For manufacturers to meet the 2020 compliance deadline and stay on top of an increasingly competitive market, it’s a good idea to begin preparing now. A lack of preparation could mean costly headaches and time-consuming setbacks.
Compliance will be no small task, and many have yet to roll up their sleeves. Recent research by the KPMG and Regulatory Affairs Professional Society found two striking facts:
• 41% of the device companies surveyed haven’t evaluated the long-term maintenance necessary for compliance with the upcoming regulation.
• 58% had no strategy in place for fixing gaps in their clinical data or data collection processes.
What makes compliance such a challenge? A big part is the new definition of clinical evaluation as systematic and planned processes to continuously generate, analyze, and assess data about a device to verify its ongoing safety and performance. That means device companies will have to collect and manage vast amounts of data during product development and afterward – a complex task that organizations may not have the resources to handle in house. The rise of CRO outsourcing across clinical research shows that drug and device companies already face a strain in in-house resources – and MDR stands to spread them even thinner.
eClinical resources that keep up
With all this change, organizations have a lot of different considerations to juggle. Here’s a big one from the technological perspective: How does the evolving nature of clinical trial regulations impact eClinical vendor selection?
Here are a few key considerations:
• For sponsors conducting trials in-house, simplifying and streamlining processes in the face of new regulatory burdens couldn’t be any more important. Does your eClinical platform keep you reliant on time- and resource-intensive programming and other professional services? Does it require lengthy training and onboarding? If so, steer clear.
• The best eClinical technology vendors will vigilantly follow regulatory changes and promptly adapt software to keep up with the times.
• Check eClinical software vendors’ relationship with regulators. Does the vendor hire people with experience working with or in the FDA or other regulators? Are they in direct communication with regulatory bodies to keep their finger on the pulse of updates and changes?
• Are there features that make it easy to stay compliant? For example, an auto-enabled audit log helps to avoid regulatory trouble due to audit trail lapses. Keep in mind that it’s ultimately up to users to stay compliant – vendors can’t do much more than make it as easy as possible to do so.
In the brave new world of medical device, those who adapt fastest and create the most value will have the advantage. MDR will no doubt bring its share of challenges, but also opportunities for new growth and innovation. Taking advantage of eClinical vendors that keep their ear to the ground for regulatory changes is one simple way to stay compliant and bring high-value devices to market faster.