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MDR and IVDR: reshaping Europe’s medtech industry
Chief Executive Officer, MedTech Europe
In May 2017, after years of development, the European Union released final versions of both the Medical Device Regulation (MDR), and its twin, the In Vitro Diagnostic Regulation (IVDR). These regulations, which go into effect in 2020 and 2022, respectively, are spurring a medtech revolution. They will significantly reshape how medtech companies develop and market their products in Europe.
We have strongly advised senior executives at medical technology companies to seriously consider the potential impact of these rules on their current and future operations. Compliance with the new regulations will require companies to significantly change their existing business practices. Medtechs must not only invest in quality management systems and evidence collection for products in development, but also provide additional clinical data to support already marketed devices.
Companies can’t afford to delay their compliance activities any longer. If they haven’t done so already, it is critical that medtechs perform gap assessments to understand what steps are required to remediate their devices and diagnostics.
Understanding the impact of the new regulations
For companies registering devices in Europe, the MDR and IVDR are set to raise the bar on product safety and function — even as they also raise questions. In the case of MDR, device companies must now measure clinical performance and continue to collect clinical data following market launch; IVDR also requires diagnostic developers to collect evidence demonstrating a clinical benefit and changes classifications that affect product certification renewal. Also in the case of IVDR, around 80% of IVD products will require CE approval for the first time. Previously, only around 20% were required to obtain them.
Because of the costs associated with compliance, the new legislation could have a significant impact on the product portfolios of medtechs small and large. Historically, medtechs have been able to use general data from other companies as part of their registration dossiers. Because of the changing evidentiary standards for MDR and IVDR, that will no longer be the case. Depending on the costs to collect the required clinical evidence, for instance, companies may decide it makes more sense to divest an asset than invest in the mandated product changes.
MDR and IVDR could also impact market access. For instance, studies estimate that the number of medical technologies sold in Europe in 5 to 10 years could be heavily affected as companies assess whether the investments required to make devices compliant are justified based on current and future product sales.
Finally, Europe’s notified bodies, the more than 50 groups across Europe that evaluate compliance and have the regulatory authorizations required to grant product certifications, are under significant pressure. They will need to review tens of thousands of medical technologies as a result of MDR and IVDR. A major concern is a potential shortage of notified bodies able to grant CE marks, potentially limiting product approvals.
A challenge to future innovation?
There’s still a lot of work to do to clarify how both MDR and IVDR will be implemented. This includes the creation of additional legislation that translates what is essentially a political document into technical language that spells out the practical considerations tied to MDR and IVDR execution. Industry groups such as MedTech Europe will continue to play a key role here, helping device manufacturers interpret key wording in the legislation as they begin their compliance and remediation efforts.
While the costs of implementing MDR and IVDR are significant no matter the size of the manufacturer, they are particularly challenging for smaller players. Indeed, for many smaller medical technology companies, satisfying these new requirements is akin to climbing Mount Everest; the effort required to comply with the legislation is so large, they don’t know how to deal with it.
These smaller medical device players are the lifeblood of innovation. As an industry, we have to be careful to build mechanisms that allow them to get the needed support to document the right clinical evidence for continued product registrations.
And, it won’t be just product registrations that are potentially affected. These regulations could negatively affect the financing of innovation, too. Venture capitalists are already asking hard questions about the capacity of medtech innovators to develop and market their products according to the new regulations. VCs are also assessing how MDR and IVDR will affect their ability to generate returns on medtech investments, since the cost of introducing a product in Europe is going to go up.
While MDR and IVDR create challenges for medical technology companies, they also create opportunities. As part of the new regulations, monitoring systems will make it quicker and easier to identify specific issues tied to marketed products. Ultimately, such data strengthens the public’s perception of the CE mark, and of the medical device industry overall.
Indeed, strengthening the product registration process is critical if medtechs want to build trust with regulators, physicians and patients. In recent years, that trust has eroded steadily as a result of high-profile device scandals. These new regulations offer a major opportunity to reverse course and reinforce the medtech’s reputation for quality and innovation.