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The Implant Files: EU Blamed For Regulatory Inadequacies The World Over While 'Wrath'-Behrendt Fumes

 
• By Amanda Maxwell

All over the world, the medtech industry woke up Monday morning to read highly critical reports of the way the medtech industry is regulated. Investigative pieces accuse the medtech industry of putting profits before safety, of sabotaging the EU's best efforts toward more appropriate regulation, and treating patients as guinea pigs. This is a first look at the International Consortium of Investigative Journalists' Implant Files investigation from an EU perspective. 

Business concept illustration of a businessman being guided by a hand holding a flashlight uncovering arrow sign.

On Nov. 25, the International Consortium of Investigative Journalists (ICIJ) began unleashing the conclusions of a yearlong massive investigation into the medtech industry on a scale far exceeding anything carried out before – with a battery of further reports due over the coming week. The initial news was picked up all over the world by media outlets.

The main point that ICIJ is making is that patient safety is being compromised in countries throughout the world, with insufficient tracking of adverse events and recalls, and companies putting profits before safety

Global Safety Database

To increase transparency and to provide information around the world where such information is scarce, ICIJ has built the world’s only publicly searchable global database of recalls and safety warnings. The International Medical Devices Database includes 70,000 records from 11 countries, and will be updated with data from more jurisdictions in the coming weeks

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