Medical devices are a huge and very heterogenous group of products, varying from wheel chairs and hospital beds, diagnostic devices, and basic surgical materials to the most sophisticated and technically demanding instruments and implants for debilitating and/or life-threatening conditions. Medical devices, as a group, are therefore intended for use by potentially also very different groups of end users, for example, from isolated, handicapped patients to highly qualified surgeons working in a highly secured environment. The acceptability of risks and hazards that are potentially associated with the use of medical devices may therefore vary extensively.

Medical devices are regulated in the European Union by three directives: Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices, and Directive 98/79/EC on in vitro diagnostic medical devices.

These regulations were needed to protect consumers and patients, including their health and their rights, to facilitate trade throughout the European Union, and to harmonize standards throughout the member states to allow mutual recognition of certifications.

These well-defined and recognized standards pertaining to the investigation, design, manufacture, and quality assurance of devices essentially create a common understanding that facilitates communication between the major players, that is, the manufacturer, the Notified Bodies that provide the required Conformity European (CE) certifications, and the regulating Competent Authorities of the member states but also ultimately result in facilitating the flow of trade within the European Union, which was a major force driving the creation of the Medical Device Directives.

All EU member states are required to apply the provisions of these directives in their national law but are also still free to add additional items as well.

Whereas the regulatory assessment of medicinal products or drugs is essentially based on demonstrating clinical efficacy, clinical safety, and the quality of the drug from a manufacturing point of view, the focus of the market authorization procedure of medical devices in Europe is mainly on an in-depth assessment of potential safety risks and hazards associated with their use and on the containment of these, while ensuring that the devices also perform as proposed and comply with essential quality standards.

Based on the potential risks associated with their use, the duration of contact with the human body, and the degree of invasiveness, medical devices are classified into four different classes: Class I, Class IIa, Class IIb, and Class III.

Detailed guidance as to the definition of what products should be considered as medical devices, and which products not, and to which class a specific medical device
belongs to can be obtained from consulting the Medical Device Directives and/or Notified Bodies’ Web pages.