Conducting Medical Device Clinical Trials in the EU

Abstract

Clinical trials of medical devices are costly, time-consuming and can make or break the fortunes of a company. In addition, European laws create a labyrinth of regulations for clinical trials that needs to be navigated with skill, dexterity and knowledge. Therefore this report will furnish the reader with information on why, when and how to conduct a clinical trial, and guide you through all stages of the trial: from its preparation to capitalising on the results, highlighting the potential pitfalls along the way.

The strategies discussed in this report can be applied successfully to any market in the world. However, the legislation that governs the conduct of clinical trials varies globally and, therefore, this report cover those countries which are governed by the European Commission Directives.

Although this report traces the development of a device from its design to final marketing, it will only discuss these events in terms of how they affect and can be affected by clinical trials, and the focus of the report will be on constructing efficient and effective clinical trials for medical devices in general, with some specific examples.

The report covers clinical evaluation, which can take two forms: a collation of scientific literature or the results of clinical trials. A clinical trial, more properly termed a clinical investigation when referring to a medical device, can be described as: A systematic study of human subjects to verify the safety and performance of a specific medical device under normal conditions of use.

Clinical trials (investigations) therefore act as a method of predicting the future and long-term behaviour, efficiency and safety of a device in situations where there are historical data on the device that can act as a valid predictor of its performance. This is a legal requirement to gain marketing approval for a medical device in the countries covered in this course and can also act as a marketing tool for a company to show objective evidence of the advantage of its product over a competitive technology and lever purchasing decisions.