Clinical Investigations on Medical Devices, after the New European Regulation (2017/745)

Abstract

Medical devices (MDs) include different products and their importance in the healthcare industry is truly remarkable. The recently issued Regulation 2017/745 (Reg. 2017/745) introduced several major changes concerning planning, conducting and reporting of clinical investigations (CIs). Manufacturers and independent researchers would have to adapt quickly to this complex regulation, as the transition period from the previous regulations to the new one would last only three years. The present study having analysed Reg. 2017/745, provides a reference guide for researchers willing to conduct a CI. In particular, this study focused on six aspects of practical interest: (1) significance of CIs in the clinical evaluation of MDs, (2) aims of a CI, (3) cases where a CI is mandatory and exceptions to this rule, (4) application procedure for a CI, (5) requirements for conducting CI, (6) serious adverse events (AE) reporting (7), CI results. The regulations governing CI are influenced by different international, national and regional laws and guidelines. The aim of the paper is to create awareness among the readers about complex regulations and provide the readers a reference to the EU regulations. In addition to that, the authors stress on some issues that they consider to be of particular importance. Even though this paper does not serve as a substitute or replacement of the regulation; it acts as a guide for the reference of the readers with respect to the EU, national and local regulations. The authors conclude that the design and conducting of CIs demands that the personnel in charge have the relevant training and expertise in the field of MDs.