Threading the Needle
The European Commission recently gathered in Brussels, Belgium, to solicit ideas from industry experts, clinicians and regulators on ways the agency can balance cost effectiveness with medtech innovation as it revises the Medical Devices Directive.
The Commission held a conference on March 22 titled “Exploring Innovative Healthcare: The Role of Medical Technology Innovation and Regulation.” The one-day event included both political-level discussions focused on ways medical device innovation initiatives could be harnessed to help address short- and long-term healthcare challenges in Europe, and technical-level discussions covering European legislation related to medical device commercialization and innovation.
On its own, the conference primarily seemed to serve as another consensus-building mechanism necessary to get multiple—and at times oppositional—constituencies aligned. But with the pending recast of the European Union’s (EU) Medical Devices Directive expected relatively soon (with relative being the key word here), commissioners’ efforts to more closely link support for development of cutting-edge medical devices to more effective EU healthcare management should be a welcome sign for industry. Ultimately, however, it will be the details more so than the agreements that will determine the effectiveness of this effort.
And the answers are not expected to come easy—the revision of longstanding medical device regulations is very likely to be as simple as learning laparoscopic suturing.
Political Takeaways
In the morning political session of the conference, participants discussed medical device innovation in the context of an aging European population and the economic challenges facing a handful of EU member states. Session contributors agreed upon high-level issues such as additional patient-centered innovations; greater integration of innovation with IT and new materials development; greater focus on cost-effectiveness; and the need for a more holistic approach to innovation.
Participants also listed several goals going forward:
• Demand-driven innovation that allows healthcare providers and patients to become more directly involved in medical technology research and development.
• Sharing national best practices and research throughout Europe.
• Improving collaboration and dialogue among medical technology constituents.
• Improving information and training for healthcare providers and patients on innovative products.
• Promoting innovation through public procurement policies.
Participants agreed that the roughly 18,000 small- and medium-sized enterprises that make up the bulk of the EU’s device industry need better support, whether it be through more efficient patenting processes or innovative funding schemes such as public-private partnerships.
To facilitate these efforts, adjustments to the EU regulatory framework also will be required, participants noted. Interoperability issues will require particular attention as use of electronic and mobile health systems increases. Regulators also should develop capabilities to expand traceability of medical devices to boost patient safety and better manage adverse event reporting and product recalls.
Technical Takeaways
The afternoon conference session focused on technical issues, and participants emphasized the need for a “robust, transparent and proportionate” regulatory structure to support development of innovative medical technologies. Paola Testori Coggi, European Commission Director General, Health and Consumers, opened the session by telling attendees that the discussion was just one of many that must take place before the Medical Devices Directive can be revised. There were various presentations from different entities who had been invited to share their perspectives. All participants who wanted to provide verbal comment were permitted to do so. And of course, as with all EU Commission-hosted meetings, there were translators there to help speakers voice their opinions in their language of choice.
Perhaps the most significant suggestions were proposals for more extensive cooperation between national authorities during pre- and post-market phases of medical device commercialization, specifically by establishing greater uniformity of conformity assessments among Notified Bodies. In addition, participants said Notified Bodies should assess only those devices in which they have appropriate competence and expertise.
To boost post-market device safety, participants urged regulators to centralize the notification and analysis of serious incidents to facilitate EU-wide responses to such events and protect public safety.
Among participants’ other major recommendations were the formation of a centralized public database to contain information on medical devices, manufacturers and authorized representatives, clinical investigations and corrective actions. The database also would provide tracing capabilities of devices for safety purposes. It is recognized that Competent Authority use of Eudamed is compulsory beginning this month; however, access to Eduamed is limited and will not publicly be accessible.
A more extensive collection of clinical data from pre-market studies and post-market surveillances also was advocated to support clinical evidence required for regulatory as well as reimbursement purposes.
Given the budget difficulties afflicting some EU member states, however, the costs and resources necessary to set up such a regulatory infrastructure—not to mention maintain adequate healthcare delivery systems—are not insubstantial. Pooling resources among multiple national competent authorities as well as setting up funding mechanisms on national levels could address resourcing challenges, participants suggested.
Finally, recent published reports about the differences between the EU and U.S. medical device regulatory systems were mentioned (faithful readers might remember reading about those differences in this column just last month).
Regulatory ProcessCalled into Question
For the most part, the conference resembled the consensus-building instrument it was meant to be. But one presentation by the European Society of Cardiology raised more than a few eyebrows among attendees. Alan Fraser, M.D., a board member of the European Society of Cardiology, claimed the EU’s regulatory system for medical devices is too lax; he used clinical evidence of inadequate premarket review processes for some Class III heart valves and stents to back up his claim. Fraser highlighted a few cases that turned into scathing indictments of the system—mainly devices that had obtained CE marking and then were withdrawn from the market for reasons that should have been detected in the Notified Body review. He recommended greater prioritization of clinical safety, more premarket testing and more clinical evaluations prior to approving high-risk devices.
EU regulatory representatives (not to mention medical device manufacturers specializing in cardiac applications) reacted with great displeasure but acknowledged some of the weaknesses in the current regulatory system.
The Medical Devices Directive’s Main Objective
Testori Coggi concluded the afternoon session by affirming the main objective of the Medical Devices Directive: to protect patients within the context of a functioning market. She touted the strengths of the EU system while also acknowledging its weaknesses. The concluding remarks were divided into four areas: robustness and transparency of the regulatory system; coordinated premarket and post marketing; financing the regulatory system; and, management of the new system. Only time and the proposed recast of the Medical Devices Directive will provide details on the vision for its implementation and how the revised EU medical device regulatory garment ultimately will be sewn by its legislative seamstresses.
Stewart Eisenhart is regulatory editor and Evangeline Loh, Ph.D., RAC, is vice president of regulatory affairs for Emergo Group, an international medical device consulting firm providing regulatory, quality assurance and distribution consulting services. Evangeline can be reached at evangline@emergogroup.com.