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Medical device regulation: Is a national database the right solution to unsafe devices?

November 26, 2018

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The Implant Files, an investigation involving 58 media organisations including the BBC and The Guardian, has uncovered a lack of consistent medical device regulation. Unlike drugs, medical devices do not have to go through a rigorous clinical trial procedure, meaning devices can make their way onto the market without being tested on humans first. The investigation has found that some devices have been tested only on baboons or pigs before getting the go-ahead for human patients.

Governments in some countries do not have any form of medical device regulation, and in the ones that do, a lack of transparency and robust regulation means that device companies are able to abide by lower safety standards.

Read More on medicaldevice-network.com