Volume 26, Issue 2 - Medical Devices 2017
Transparency – left to its own devices until now
Author: Fiona Dunlevy
Abstract
Abstract
Transparency has been an objective in the pharma world in recent years, culminating in the recent decision by the EMA to release full clinical study reports into the public domain. In spite of the publicity surrounding transparency and data sharing in pharma, the world of medical devices has largely flown under the transparency radar, but change is on the way. The final text of the long-awaited Medical Device Regulation was published in late February, and jumped the final hurdle of adoption by the European Parliament in April. This overhaul was prompted by scandals surrounding silicone gel breast implants and metal-on-metal hip replace - ments in the early 2010s that highlighted the lack of oversight and transparency. So why is this important and what are the implications for transparency?
Transparency has been an objective in the pharma world in recent years, culminating in the recent decision by the EMA to release full clinical study reports into the public domain. In spite of the publicity surrounding transparency and data sharing in pharma, the world of medical devices has largely flown under the transparency radar, but change is on the way. The final text of the long-awaited Medical Device Regulation was published in late February, and jumped the final hurdle of adoption by the European Parliament in April. This overhaul was prompted by scandals surrounding silicone gel breast implants and metal-on-metal hip replace - ments in the early 2010s that highlighted the lack of oversight and transparency. So why is this important and what are the implications for transparency?
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References
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