Preparing for the EU’s MDR

On May 26, Europe’s medical device regulation (EU MDR) will go into effect. With roughly 500,000 different medical devices currently sold in the EU, the impact of this update in the European marketplace is enormous in scale. Entities responsible for medical devices must conform to new, stricter requirements. But are these medical device companies prepared?
 
According to Greenlight Guru’s recent 2021 EU MDR Preparedness Study, only 18 percent of medical device companies are ready for EU MDR. With such limited time left to prepare, this is alarming.
 
The risk of noncompliance is costly and inefficient, but many organizations are lost on where to start. To help set them on the right path, our team has outlined key obstacles as well as a preparedness plan that identifies key areas where industry professionals can double down and close the gap for compliance before the deadline.
 
What’s Standing in the Way?
When speaking with medical device professionals about their challenges in preparing for EU MDR, three key issues surfaced: a lack of resources, planning, and guidance.
 
Insufficient resources stood out among the rest as a top challenge—and the pandemic only exacerbated the issue. According to the Greenlight Guru 2021 medical device industry benchmark study fielded in October 2020, 63 percent of industry professionals feel the pandemic negatively affected funding at their organization, 39 percent found COVID-19 harming financial viability, and another 59 percent stated it had negatively affected time to market. With competing major concerns, it’s understandable a lack of resources is a core challenge for EU MDR preparedness.
 
Close behind limited resources is a lack of planning. The unfortunate reality is that many medical device companies did not adequately prepare for EU MDR. According to report findings, 46 percent of industry professionals stated they were confused about the new requirements and what steps were needed to comply with the new regulation.
 
Some industry organizations, like Medline Europe, had planned training courses to cover the EU MDR requirements and help overcome the lack of guidance. However, many of these courses were canceled due to COVID-19, leaving 32 percent of industry professionals feeling they lack the right expertise and processes to support transitioning to the new requirements set forth in the medical device regulation. To help supplement the lack of guidance, Greenlight Guru recently hosted a free, 5 day virtual summit focused on everything device and IVD makers need to know about the EU MDR and IVDR.
 
Your Preparedness Plan to Ensure Readiness
While organizations subject to EU MDR should be close to completion in terms of compliance, our research shows otherwise. With the transition period drawing to a close, there are some last minute preparedness activities medical device companies can start today to increase the likelihood of hitting the deadline.
 
Internal Test-Run Audits
Internal audits allow industry professionals to ensure they’ve accounted for all applicable medical device requirements. Some organizations may be counting on current certifications under MDD to delay their deadline, but they should still schedule mock audits and optimize based on the results.
 
Cross-Functional Survey
Ensuring compliance with EU MDR needs buy-in and collaboration between a variety of internal teams, including R&D, regulatory affairs, quality assurance, management, and other stakeholders involved throughout the supply chain. Soon, consider issuing an internal “health check” survey to outline what each department feels are the most imminent threats to compliance. From there, prioritize resources in this final stretch.
 
Plan Beyond the Deadline
Even if your company has secured more time with certifications under MDD or is on the final sprint to compliance, plan beyond the May 2021 deadline. Unforeseen delays and retroactive document review can bog down companies. One European trade group predicts that due to a high amount of expiring certificates in 2024, there could be an insufficient number of notified bodies, leading to a medical device shortage in the EU—a previously unforeseen delay.
 
At this point, it’s no small feat to prepare for EU MDR. But, it’s not impossible. By mitigating key challenges and implementing the three recommendations from our preparedness plan, medical device companies can set themselves up for a successful transition to compliance with new regulation.
 

---

Nick Tippmann is the vice president of marketing for Greenlight Guru, a medical device quality management software (MDQMS) that provides an industry-specific solution to help device makers around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Nick is lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, Nick co-founded and led a media and event production company that was later acquired.