Countries in the European Union have long been the first to receive new innovations in medical technology, as the EU’s Medical Device Directive (MDD) provided quicker routes to implementation of new devices than its equivalent in the USA, the Food and Drug Administration (FDA). However, on both sides of the Atlantic, the regulatory pace is likely to change over the next few years—in opposite directions.
The EU is moving to replace the MDD with the Medical Devices Regulation (MDR): a more extensive regulatory document, introducing significant revisions to quality and safety standards and the range of regulated devices. The MDR was initiated in May 2017, and a three-year transition period applies. Current MDD certificates remain valid, but cannot be renewed, meaning that from 26 May 2020 onwards, all medical devices brought to market in the EU and Switzerland must conform to the MDR. While increasing demands on the standard of clinical data and safety profiles of new technology, medical device innovation in the EU is likely to see reduced speeds on the road to the CE mark.
Meanwhile, the US FDA has published its strategic priorities for the MDD-MDR transition period of 2018–2020, outlining an aim to “reduce the time and cost of generating clinical evidence, typically the most expensive and lengthy regulatory requirement for marketplace entry.” The FDA states it has adapted their policies and procedures to “facilitate and streamline the development and approval” of clinical trials in the USA, and redistributing the data collection requirements pre- and postmarket. “By striking the right balance between premarket and postmarket data collection we can help assure we get the right data at the right time, thereby creating incentives for timely patient access to high-quality, safe and effective technologies to improve their health and quality of life.”
Speaking on the subject in the CX Innovators Showcase at the Charing Cross Symposium (CX; 24–27 April, London, UK), Veryan CEO Chas Taylor noted that the FDA’s strategic direction is “more open and approachable,” and while it does not change the burden of proof, it “makes the system easier to navigate.” The EU MDR on the other hand, “will increase barriers to entry in Europe” with new regulation, Taylor said.
The panellists of the session, Gido Karges (Wangs, Switzerland) and Jeffrey Jump (Most-sur-Rolle, Switzerland) similarly feared that the pace of innovation in Europe will be diminished, with Jump stating that “the golden age of innovation in Europe is coming to an end.” Jump suggested “CE mark lead approval time will at least double (6–12 months)”, and claimed “the number of innovative medical devices receiving CE mark will drop down by an estimated 30%.”
Karges explained the ramifications: “Expenditures associated with MDR compliance are enormous. Due to these costs, device developers will need to make choices about which areas of their business to remediate first. Some may decide the costs of remediation exceed the business opportunity, choosing to sell or close down certain product lines. As manufacturers decide to discontinue legacy products, suppliers go out of business, dragging other manufacturers who bought from them behind. German and Swiss health authorities predict the extinction of 30% of all medical device manufacturers. They also expect that 50% of all medical devices will be discontinued or fail to meet the requirements. Patients might be at risk—it is a very grim outlook.”
In contrast, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is collaborating with the US FDA to allow “globalisation” of approval studies, Taylor highlighted, in an initiative called “harmonisation by doing.” The FDA state that the initiative will see them agreeing with the PMDA, academia and industry on internationally developed standards for global clinical trials related to cardiovascular devices, addressing “regulatory barriers that may delay timely medical device approvals in both countries.”
Jump summarised, “The FDA and other competent authorities have released new regulations and guidelines in order to decrease the burden of getting market access for innovative devices.”
“Europe is now heading in the opposite direction, particularly for innovative products. Due to the uncertainty of MDR implementation and interpretation, increased cost of compliance, fragmented distribution and divergent reimbursement policies, the 40-year old model of ‘go to Europe first’ will be challenged. Europe may have to wait for innovative medical devices to be proven safe and effective in other markets before European patients will have access to improved technologies. I believe innovators will follow the path of least resistance and vote with their feet.”