In light of the incredible circumstances around the COVID-19 pandemic, the EU postponed the EU MDR implementation to May 26, 2021. Ostensibly, the delay allowed companies to shift precious resources toward fighting the pandemic and providing useful medical devices without worrying about regulatory hurdles. While some companies appreciated the extension to achieve compliance, it was a benefit secondary to the EU MDR’s larger goal to better serve public health.
 
Still, despite an extra year of preparation, many companies either struggled to get needed resources or intentionally delayed preparations. Our survey of medical device professionals found 59% of respondents reported a lack of resources as a critical barrier to preparedness — but lack of planning followed close behind, a remarkable finding given the EU MDR’s four-year transition period.
 
While the pandemic remains a serious concern across the EU and the world, medical device companies face a pressing need to prepare themselves for new regulations. Where do these COVID-related constraints remain, and how can these companies prepare for change after the EU MDR deadline?
 
Key Challenges: Resources and Planning
Our survey discovered that leadership and culture weren't strong contributing factors to the concerning lack of preparedness. Respondents worried more about resources, processes and clarity. The resources issue is understandable: companies faced disconcerting supply chain disruptions affecting their EU MDR preparation. Resources had to shift to meet exceptional COVID-related demand, creating scarce supplies for other medical needs.
 
The lack of resources also caused challenges for medical device companies. Of those responding to our survey:
 

• 63% reported the pandemic had negatively affected their companies’ funding.
• 59% said it negatively affected time to market.
• 39% reported the crisis threatened their organizations’ financial viability.

 
The pandemic launched a multi-front war on companies who had to contend with staying in business and preparing for the EU MDR’s implementation.
 
The shared worry over processes is somewhat understandable. The EU’s notified bodies were meant to handle the influx of device applications, clinical data and demand for audits ahead of the deadline. But systemic constraints like social distancing guidelines, emergency approval of COVID resources, and international travel bans slowed down review processes. As companies push more devices into the EU market in future years, demands on constrained notified bodies will increase.
 
That said, companies cannot wait for this process issue to resolve itself. Organizations that registered their products under the old MDD guidelines may expect a reprieve from new regulations. However, while these companies must comply with EU MDR by the expiration date of each CE mark instead of the May 2021 deadline, they can’t register any new products without current EU MDR compliance.
 
The grace period for devices with existing MDD certificates issued prior to May 2020 — not new devices, which companies had to register by May 26, 2021 — ended on May 26, 2024. The In Vitro Diagnostics Regulation (IVDR) enforcement date remains unchanged. The MDR and the IVDR application dates now fall only a year apart, which may further strain notified bodies.
 
Limited notified body access and supply chain disruptions may further exacerbate the issue of inadequate preparation. Companies facing confusion about new regulations or struggling to develop a plan face a steep climb in the months and years ahead.
 
Quality Remains Critical
Within the issue of lack of planning, our research uncovered specific friction points. Critically, 70% of respondents had not completed an operational plan for business continuity, without which it becomes easy to lose track of certificate expiration dates and other items needed for compliance. Companies also struggled with determining a reclassification action plan (62% incomplete) and documenting a strategy to remediate clinical data gaps (51% incomplete).
 
Companies can more easily organize gap remediation strategies for existing products in the EU market. Planning those strategies, however, becomes a much larger issue for new products because of increased scrutiny around device quality.
 
A recently published McKinsey report highlighted the importance of smart quality for the future success of medical device companies. In addition, several EU MDR provisions mandate quality system functions like demonstrating closed-loop traceability before a device can be certified. Companies cannot afford to disregard quality in their planning initiatives.
 
Plan Ahead with Quality in Mind
As you plan ahead, consider incorporating a quality management system (QMS) specially designed for medical devices. As notified bodies and regulators implement future changes, a purpose-built QMS should automatically reflect these updates so you can manage and maintain quality across all systems and processes without the added regulatory burden.
 
In addition to a medical device-specific QMS, consider other options designed to help you prepare for the EU MDR implementation:
 
Cross-functional survey
You’ll involve many organizational stakeholders in your compliance efforts. Quality assurance, regulatory affairs, suppliers, R&D and IT all have a shared responsibility. Run a short “health check” survey of these functional domains. Seek feedback about the largest compliance roadblocks they face to help prioritize resources and avoid surprises.
 
Mock Audits
It will take time for notified bodies to resolve the bottleneck of audits. Prior to the official audit, you can perform internal audits and a final mock audit to ensure proper implementation of key requirements. Mock audits can help you optimize your quality management processes even if you have certifications under MDD that extend your EU MDR deadline.
 
Post-May 2021 Planning
With the notified body bottleneck, how critical is planning ahead? Very. Other potential roadblocks can further slow down the already long process of retroactive document reviews. Even if you’ve “bought time” with certifications under MDD, begin your EU MDR compliance planning immediately to mitigate potential issues later on down the road.
 
While the pandemic postponed the EU MDR’s initial activation date, no circumstances should ever delay the work to ensure medical device quality. Your company will benefit from the actions of forward-thinking leaders who champion quality by planning ahead to address evolving regulations.
 

---

Jon Speer is the founder at Greenlight Guru a medical device quality management software and a medical device guru with over 22 years of industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.