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MDCG 2021-24 Guidance on classification of medical devices - October 2021

Medical devices regulation

The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. This approach uses a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness, local vs. systemic effect, potential toxicity, the part of the body affected by the use of the device and if the device depends on a source of energy. The criteria can then be applied to a vast range of different medical devices and technologies. These are referred to as the ‘classification rules’ and are set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR). They correspond, to a large extent, to the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document GHTF/SG1/N77:2012

According to MDR Article 51 devices are divided into the following classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification is to be carried out in accordance with Annex VIII to the MDR. In addition, and according to Article 52(7)(a), (b) and (c), Class I devices can be further subdivided into Is – sterile condition, Im – measuring function and Ir – reusable surgical.

The technical documentation to be drawn up by the manufacturer must include the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII of the MDR. 

This MDCG document offers us a real supporting tool to handle and clarify classification rules of the MDR Annex VIII.  The 22 classification rules are presented as synoptic diagrams to follow to find the good classification (from page 17 of the document). Various examples are also provided.