Did we make a difference?

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.

We want to keep our content free at the point of use to all. If you value our work and are able to support it, please make a contribution to enable us to fulfil our educational aims into the future.



An Informed Dialogue Supporting Safe Innovation in Medical Technology

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.