New white paper: Product classification according to MDR and IVDR
The assessment of the risk classes of medical devices and in vitro diagnostic medical devices in accordance with the requirements of the MDR and IVDR is the responsibility of the manufacturing companies. The MDR (EU Regulation 2017/745) uses four classes (I, IIa, IIb and III) for classification, while the IVDR (EU Regulation 2017/746) uses classes A, B, C and D. The key question is: Which risk class is suitable for your medical device? Before answering this question, it is necessary to consult the regulations to determine whether the product is classified as a medical device at all. If you would like a comprehensive overview, we recommend you take a look at our new white paper.
The classification of medical devices:
The classification is made into four ascending risk classes I, IIa, IIb and III (from low to high risk).
In addition, Class I devices must be differentiated according to sterile use (Is) or the presence of a measuring function (Im).
In the context of the IVDR, there are also four classes with ascending risk – Class A, Class B, Class C and Class D – according to which the classification is made.
Incidentally, standalone software, i.e. medical software that is not used as control software for a medical device (e.g. medical apps), is also considered an active medical device according to the MDR and BfArM.
The preparation of the intended purpose and risk classification is therefore the responsibility of the manufacturer and can be carried out after consultation with the notified body if necessary.
Everything at a glance: Our new whitepaper
Do you often deal with the topic of product classification in your day-to-day work and are you looking for an overview that summarizes the most important aspects? Great, then download our new white paper and find out more about risk classification according to MDR and IVDR.