European Commission proposals on medical devices and in vitro diagnostic medical devices : initial appraisal of a European Commission impact assessment

This note seeks to provide an initial analysis of the strengths and weaknesses of the European Commission's Impact Assessment accompanying the Commission proposals on Medical Devices and on In Vitro Medical Devices (MDs and IVDs): - Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) 178/2002 and Regulation (EC) 1223/2009; - Proposal for a Regulation of the European Parliament and of the Council on in vitro medical devices. T he Commission's proposals, strengthening the legal framework for medical devices, including in vitro medical devices, 'aim to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices'. The existing regulatory framework, having been in place for twenty years, a revision is needed to fill in gaps following technological development of medical devices.