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.