Article originally published in European Pharmaceutical Contractor, September  2012

Although at first sight the rules that govern the distinction between medical devices and medicines in the EU allow for a direct and systematic approach, borderline determinations are, in practice, often difficult and the rules lack logical rigour

The European Commission is expected to publish proposals for a new EU legislation on medical devices later this year and the proposals may, for the first time, include a formal and systematic EU decision-making process for borderline determinations. However, these determinations will have to be made on the basis of the available legislation and interpretation principles, and it will be important to ensure that these are also clarified.

Read the complete article here