Before a medical device can be placed on the European market, it must comply with the legal and regulatory requirements defined by the EU Medical Device Regulation (MDR 2017/745). One of the very first — and most critical — steps in this process is the correct classification of the device.
Under the MDR, Medical Devices are classified according to the duration of use, invasiveness, the part of the body affected and whether the device is active or passive. The intended use, as defined by the manufacturer, is the key criterion for classification.
💡 The deeper and longer a device interacts with the body, the higher the risk class: Risk Class I with subclasses Is (sterile products), Im (products with measuring function) and Ir (reusable surgical instruments), Class IIa, IIb and Class III
The correct classification of your medical device is the foundation of your entire EU regulatory pathway. It affects the entire conformity assessment pathway, including the involvement of a Notified Body, the scope of clinical evaluation, and the structure of your technical documentation.
More information: Risk Classification in the EU
