Safe access to healthcare for patients is a basic right nowadays. That is ensured through putting on the market medical devices that meet strict safety requirements as laid down in the three EU Medical Devices Directives – namely, the Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices Directives. Moreover, it is also of paramount importance that the integrity of the patient and of his health data is protected at all times. Interoperability of health information systems between all the actors and devices who handle and process health data is a guarantee that this requirement is achieved.
CEN and CENELEC activities
Through their more than 20 Technical Committees dedicated to healthcare, CEN and CENELEC develop European Standards setting safety, quality and performance requirements for medical devices that are put on the European market. A large number of those standards enable manufacturers to make their medical products compliant with the European legislation in the medical sector, for the ultimate benefit of all European citizens. In addition, CEN/TC 251 ‘Health informatics’ is a Technical Committee specifically dedicated to the development and provision of European Standards ensuring interoperability of health information systems throughout Europe, with systematic harmonization with the international environment.