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News The Implant Files

Doctors demand to see evidence on safety of medical devices approved in Europe

BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5105 (Published 30 November 2018) Cite this as: BMJ 2018;363:k5105
  1. Simon Bowers, reporter and Europe partnership coordinator
  1. International Consortium of Investigative Journalists

Senior doctors, consumer groups, and campaigners for transparency are urging the European Commission to force the manufacturers of high risk medical devices to make public all the evidence they hold on the safety of their products.

The calls came just days after a global investigation into the industry by the International Consortium of Investigative Journalists, The BMJ, BBC Panorama, the Guardian, and others called the Implant Files, which uncovered thousands of documents showing the rising number of malfunctions and injuries from a range of medical devices.1

A new law for medical device regulation in the European Union was passed last year and comes into effect from 2020. It sets data transparency as one of its main goals, but the European Commission, which has been the subject of intense lobbying from the device industry, has said that it plans to withhold …

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