MDR 2017/745 is often referred to as the ‘General Medical Devices Directive’, because the majority of products regulated under the devices directives fall under its scope, from tongue depressors to MRI machines.

To provide a level of regulation commensurate with the perceived operational risk for patients and users, the MDR identifies four device classifications, which are in order of increasing risk: Class I, Class IIa, Class IIb and Class III, which are detailed in Annex VIII to the directive. It also identifies exactly what constitutes an ‘accessory’, and how these fit into the classification structure. Active implantable devices falling under Directive 90/385/EC are treated broadly as Class III device for CE marking purposes.
Understanding what classification attaches to individual devices helps determine what conformity assessment routes are open to manufacturers, and what specific requirements must be met, so this is an important aspect to be determined as early as possible in any marketing plan.
GEMAR can help you identify the classification of any device, potentially avoiding unnecessary work and expenditure - contact us for further information.