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This special edition of the European Journal of Risk Regulation deals with a highly topical, complex and controversial subject matter – the reform of the regulation of medical devices in the European Union. At first sight, and as further detailed in the following articles, there appears to be a general consensus about the need to improve the EU (and indeed the US) regulatory framework on medical devices, especially for high-risk categories of devices. Stakeholders including representatives of the industry, patient and consumer organizations, national authorities, healthcare professionals, agree that there is a need for change. However, opinions differ on what needs to be changed and how. Three alternatives for reform of the current EU systemof regulation have been debated over the past years: the adoption of a pharmastyle system of pre-market authorisation; maintaining the status quo but strengthening implementation and supervision in the Member States; or finally, introducing common technical specifications together with specific guidelines for certain high-risk devices.
Hancher et al. (Sun,) studied this question.