EU MDR Product Classifier-medical device classification tool.

Detailed Introduction to EU MDR Product Classifier

The EU MDR Product Classifier is designed to assist medical device manufacturers in navigating the complex classification process defined under the EU Medical Device Regulation (MDR) 2017/745. The primary function is to analyze product descriptions, specifically focusing on the device's intended purpose, duration of use, invasiveness, and other factors, and then cross-referencing these with the MDR classification rules. By using clear decision-making frameworks from MDR Annex VIII, the tool suggests the most appropriate classification for each product. Examples include distinguishing between Class I and Class IIa for non-invasive devices, or between Class IIb and Class III for surgically invasive devices. This tool helps manufacturers ensure compliance with regulations and avoid misclassification, which could lead to legal complications or market access issues. For instance, a non-invasive device intended for storing body fluids is typically Class I, but if intended for storing blood and connected to a higher-risk device, it escalates to Class IIb.