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: Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices Directives, which have been revised into two new Regulations on Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices revised In Vitro Diagnostic Regulation (EU) 2017/426 (IVDR).
Moreover, it is also of paramount importance that the integrity of the patient and of their 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 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 within the international environment.
CEN Standards in healthcare aim to cover the Assessment of workplace exposure to:
- Chemical and biological agents, Mechanical vibration and shock;
- Explosive atmospheres, explosion prevention and protection;
- Intrinsically-safe apparatus Active;
- Electrical apparatus for potentially explosive atmospheres;
For more information contact Jennifer OGBONNA.