CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives and is a legal requirement to place a device on the market in the European Union.
As Consultants under the Medical Devices Directives, we have one of the broadest scopes of consultancy
- The Medical Devices Directive (MDD) – all products
- The Active Implantable Medical Devices Directive (AIMDD) – all products
- The In Vitro Diagnostics Directive (IVDD)
This means whatever type of device a manufacturer wishes to market in Europe, where CE marking is now a legal requirement, ICGroup has the technical expertise to assist and provide appropriate conformity assessment services.