Legal and regulatory update

John Wilkinson

DOI:https://doi.org/10.5912/jcb152

Abstract:

The European Commission has launched a public consultation on its proposed amendments to the Medical Devices Directive (MDD) (Dir 93/42/EEC). The aim of the European Commission's proposals is to improve the coherence, transparency and effectiveness of the legislation governing medical devices in line with the recommendations of the report produced in 2002 by the European Commission's Medical Device Experts Group. This report recommended that the requirements for clinical evaluation of medical devices be clarified, transparency be increased by amending post-market surveillance requirements and that the decision making process be improved by empowering the European Commission to make binding decisions where individual national opinions differ on whether a product falls within the definition of 'medical device'. The report also recommended that the three directives governing medical devices (the MDD, the Active Implantable Medical Devices (AIMD) Directive 90/385/EEC and the In-vitro Medical Devices (IVDD) Directive 98/79/EC) should be made more consistent with each other.

Keywords:en ,