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The Foundation for Law, Justice and Society (FLJS) is an independent not-for-profit institution that aims to promote an understanding of the role of law in society. We identify and analyse issues of contemporary interest and importance, disseminating the insights of decision-makers and experts to a global audience through our extensive online resource of free-to-download Policy Briefings, Opinion Pieces, and multimedia podcasts.

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An Informed Dialogue Supporting Safe Innovation in Medical Technology

Author: 
Christopher Hodges and Sonia MacLeod
Publication date: 
Thu, 20 Nov 2014

What do we want from medical technology, and how can we get it?
 
This policy brief addresses a series of interrelated questions on how regulatory reform in the European Medical Devices sector should proceed. The complexity of the regulatory framework and the impact of a small number of high-profile failures, notably the PIP breast implant scandal, have led to widespread misunderstanding among heath-care professionals and patients alike regarding the regulation of medical devices.
 
The policy brief assesses the following key issues:

  • How do we ensure patient safety and care?
  • How do we balance safety and innovation?
  • How do we successfully operate a sophisticated but complex multi-actor pan-EU regulatory system, to maximize public confidence in it?

The authors conclude by identifying 15 recommendations to encourage closer collaboration between the policymakers, regulators, manufacturers, health-care professionals, and patients involved in, and affected by, the ongoing reforms.