The new EU Medical Device Regulations (EU MDR) go into effect in 2020. To the rest of us that may seem like a long time, but for companies marketing— or planning to market—their devices in Europe the clock is already ticking. The sweeping regulations will likely affect the marketing of most CE-marked devices.
“It's an overarching program that ensures a device manufacturer's product portfolio is reviewed from all angles to meet the requirements of the regulations," says Colin Jacob, a Philips senior regulatory affairs specialist. The addressed areas span the business and include technical documentation, quality assessment, clinical evidence, performance data and more.
To meet these requirements, teams need to be proactive. Philips has formed a team focused on the implementation of EU MDR. Its members include Jacob, who provides guidance and brings regulatory interpretation to the EU MDR team. Successfully preparing for the transition, he says, requires the aforementioned proper planning as well as cross-functional collaboration between several teams including supply chain, engineering, purchasing, and IT, to ensure timely implementation to our Quality Management System (QMS).
What will change?
The Regulatory Affairs Professional Society reports that's it critical to understand the differences between the existing Medical Device Directive (MDD) and the new MDR. “It's highly probable for most legacy devices that a review of Annex I, General Safety and Performance Requirements will identify new conditions that will need to be addressed and updated," the RAPS information notes.
Jacob says that the most significant change will likely be the amount of clinical and performance data manufacturers need to show that a device is meeting the requirements of the EU MDR. “This data cannot be collected overnight," he says. For instance, under the new regulations device manufacturers will be expected to present and trace a large amount of post-market surveillance data in an organized fashion.
Getting your arms around the EU MDR may seem challenging, especially for new manufacturers. But Jacob says the sooner companies begin their planning, the better. He provided four tips for helping your company more efficiently prepare for the new regulations:
1. Evaluate your priorities. This is true from both a Q&R and business perspective. In the past, device manufacturers often introduced products into the EU market first, because the timelines were shorter. Doing allowed companies to garner both immediate revenue and post-market data. Under the EU MDR, those timelines will be longer and that will impact how companies prioritize their workloads, staff time and product releases in Europe and elsewhere. “Businesses will need to evaluate how much resources they are willing to invest in their key markets," Jacob says. “Resources will still have to be allocated to support the global market and not just the EU." This goes for Q&R resources as well as other departments supporting the project.
2. Take a holistic approach. When it comes to managing compliance issues across multiple regions, efficiency is key. The introduction of the EU MDR is a good reminder that a holistic approach makes global Q&R easier. What does it look like? Jacob advises identifying compliance issues and placing them in buckets. For instance, collate all the pre-market and post-market issues, those that are device-specific or those that are related to the supply chain. By grouping them across geographies your teams will be better able to spot patterns, find similarities and create efficiencies across projects and workflows.
3. Communicate within and across departments. The Philips EU MDR-specific team includes Q&R professionals and other cross-functional resources each focused on supporting various aspects of the business. Sharing information about the new regulations between the team is vitally important, but so too is communicating with teams and various departments. “Cross-functional collaboration allows the creation of deliverables that can be leveraged to support the workloads of more than one team," Jacob says. Doing so eliminates information silos, ensures that there are no gaps in the Q&R strategy, and offers up the opportunities for potential work shares and efficiencies.
4. Gather feedback early and often. In the same vein, gathering and incorporating feedback on deliverables related to the EU MDR early is also important. Jacob notes that he and his colleagues routinely share ideas and ask for constructive criticism. “My favorite projects have been ones where many of us collaborated and the work was vetted by colleagues, which allowed me to see aspects I hadn't before," Jacob says. “The end result is that much better for it." In preparing for the EU MDR, Jacob's team is already collecting information from multiple subject matter experts (SMEs), and then sharing insights, progress and more across the group. “Teams need to be aware that their actions can have an impact on each other," he says.
Complying with the requirements of the EU MDR is an important undertaking. “The end goal is making sure that these products continue to properly support patients and users," Jacob says. Set your company up to successfully navigate this new era with early planning, improved communication and a cross-functional strategy that ensures everyone in your organization is on the same page.
Interested in a career in Q&R? Learn more about careers and opportunities within our quality teams at Philips.