The regulation of medical devices in the European Union and Malta : a legal analysis

Abstract

This Research Project attempts a legal analysis of the European Union’s (EU) and Maltese regulatory framework on medical devices. It examines the impact which medical devices have on EU Member States, especially in the light of their evergrowing use and recent deliberations to revise the existing EU legislative framework. The introduction of this Research Project gives a general overview of the applicable EU’s legislative framework on medical devices, which comprises three Directives. Subsequently, it gives an analysis of how the main Directive, the Medical Devices Directive (MDD) classifies the various types of medical devices it regulates. Besides, it outlines the medical devices and other products to which the MDD does not apply. Chapter 1 provides a number of definitions applicable throughout all three Directives to familiarise the reader with the key terms surrounding the area of study. Chapter 2 expands on the MDD and gives an analytical examination of its various legal provisions. It specifically focuses on three topics, namely, definitions, marketing requirements and legal requirements. This is linked with an analysis of the Maltese legislation transposing the MDD. Furthermore, for a more practical approach to the area of study, the interview held with a representative of the ‘Malta Competition and Consumer Affairs Authority’ (MCCAA) is referred to. In support of this research, Chapter 3 reviews a number of European Court of Justice (CJEU) and Member States’ Court Judgements. Chapter 4 highlights the amendments which are being proposed at an EU level to update the three medical devices Directives which were enacted more than twenty years ago, to cater for the present exigencies and be turned into Regulations. Ultimately, the concluding chapter gives an overview of what has been achieved in this Research Project and proposes further research on the subject.