By Evangeline Loh and Stewart Eisenhart The European Commission recently gathered in Brussels, Be

By Evangeline Loh and Stewart Eisenhart

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.