'Implant Files' Impact
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Latest From Implant Files
March 2019 was a busy month in terms of news for those preparing for the implementation of the MDR and IVDR, while Brexit negotiations spiraled into a new level of madness.
EU Regulatory Roundup, December 2018: Renewed Focus On Regs While 'Implant Files' Still Grabs Attention
Passing the half-way mark in the transition period to full implementation of the EU's new Medical Device Regulation (MDR) seems to have focused the attention of readers back onto technical regulatory issues.
Weeks after the "Implant Files" journalistic investigation of the device industry was released, EU industry advocate Serge Bernasconi described the results as "unhelpful" and "imbalanced." But might they also be disruptive, threatening the smooth rollout of new EU regulations? We put this and other questions to Bernasconi, chief executive of the EU's largest medtech trade association, MedTech Europe.
With increased pressure on US FDA surrounding its approach to safety and growing concerns with Bayer's Essure birth control device, the agency is now requiring the manufacturer to extend a mandated post-market study of women who have been implanted with the product, among other requirements.
'Implant Files': New Device-Failure Database Benefits Companies And Savvy Consumers, But May Befuddle Others, Experts Say
The International Medical Devices Database from the International Consortium of Investigative Journalists – an output of ICIJ's recent string of "Implant Files" stories that were critical of industry – offers information on more than 700,000 device recalls, field safety notices and safety alerts documented in 11 countries. While device-makers and shrewd consumers will discover a bevy of useful data in the public repository, it could prove confusing for laypeople. A recalls expert and an ex-FDA official weigh in.
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.
The International Consortium of Investigative Journalists started publishing the findings of its "Implant Files" investigation last month, but the two main industry groups in the US have not picked up any significant political backlash resulting from the reporting so far.
EU Regulatory Roundup, November 2018: 'Implant Files' Dominate, While Brexit/New Reg Issues Rumble On
The medtech sector was already quite overwhelmed with the new EU regulations and Brexit uncertainties. Now add into the mix the impact of the global journalistic Implant Files investigation.
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