The correct classification of a medical device is one of the first and most critical steps to ensure regulatory compliance within the European market.

We offer specialised support in determining the classification of the device (Class I, IIa, IIb, or III), in accordance with the applicable European regulations — MDR (Regulation (EU) 2017/745) for medical devices and IVDR (Regulation (EU) 2017/746) for in vitro diagnostic medical devices.

Through a detailed analysis of your device’s characteristics, mode of action, and intended purpose, we ensure that:

-The classification is accurate according to the criteria established by the MDR or IVDR;

-The applicable regulatory requirements for each class are identified;

-A suitable compliance roadmap is outlined from the start of the certification process;

-Delays or risks of non-compliance with competent authorities or notified bodies are avoided.