10 EU-Based Key Medtech Opinion Leaders React To The 'Implant Files'
Nov. 25 was the halfway mark in the three-year transition toward full implementation of the new EU Medical Devices Regulation. It was also the day the International Consortium of Investigative Journalists (ICIJ) dropped a bomb on the medical device sector, and it has been shelling the industry every day since. How are key industry experts reacting?
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Increased transparency is often highlighted as one of the major steps forward in the new EU Medical Device and IVD Regulations. But based on discussion at a Feb. 27 European Parliament committee meeting, some feel the changes do not go far enough. Is more debate needed?
Europe's biggest medtech industry and market, Germany, was in the crosshairs of the "Implant Files" and its ICIJ reporters, and predictably it caused a major stir. The episode has been a wake-up call for medtech, but industry hasn't let it develop into the crisis it briefly threatened to become, and is now looking beyond it and to the commercial challenges of 2019.
Investigative journalists, tort lawyers, the judicial system and public opinion all provide checks and balances on medical research, industrial innovation and commercial exploitation of health-care technologies. Whether those affected like it or not, these well-intentioned elements of society demand accountability of an industry that has a profound effect on all our lives. The "Implant Files" episode is a reminder for medtech stakeholders across the world that nothing can be taken for granted, says medtech industry and regulatory consultant Trevor Lewis in this guest column for Medtech Insight.