Regulatory Framework for Medical Devices and IVDs in Europe

The publication of the new Medical Device Regulation MDR 2017/745 and the In Vitro Diagnostics Regulation IVDR 2017/746 in April 2017 ushered in a new era for the approval of medical devices in Europe. These regulations repealed the European Council Directives 90/385/EEC, 93/42/EEC, and 98/79/EC and are now legally binding, requiring manufacturers and distributors to make special efforts to successfully enter the European market with their medical products. In this chapter, we address the legal environment and the additional requirements for medical device certification imposed by the new regulations. We go into detail on the definitions of what is a medical device and who is a manufacturer or economic operator for the purposes of the regulations. We also highlight changes in conformity assessment procedures and extensions in the technical documentation, particularly for the clinical and performance evaluation and the post-market procedures. The chapter also introduces and discusses the most important European standards for medical devices. Finally, we provide a brief overview of the international situation regarding the approval of medical devices with a focus on the USA, Canada, China, Japan, and Brazil, as this overview may help to identify differences and peculiarities in the approval strategies of these markets compared to Europe. This introductory chapter of the book outlines the framework of a challenging journey through the European medical device certification process and highlights the necessary requirements for a successful European market entry with a short view to the non-European medical device approval situation.