Managing the Compliance of Medical Device Equipment and Products
Eurofins, Your Trusted Medical Devices Compliance Partner
The placing of medical electrical equipment and in vitro diagnostic medical devices on the market is regulated by stringent national and international approval procedures.
- The requirements for active medical devices are documented under the IEC 60601 standards family, and form the basis for the approval procedure of Medical Electrical Equipment in most global regulatory frameworks and for compliance with the Medical Device Directive (MDD) 93/42/EEC.
- In vitro Diagnostic Medical Equipment requirements are documented for active medical devices under IEC 61010 for compliance with the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC.
Eurofins Electrical and Electronics (E&E) international network of laboratories offers testing, inspection and certification services for active and non-active medical devices to enable market access for your choice of global locations.
For more information, click on the links below or contact your nearest Eurofins E&E laboratory.