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MDCG has released guidance for classification of medical devices

Medical Device Coordination Group (MDCG) has released guidance for classification of medical devices (MDCG 2021-24). The MDCG is a group composed of representatives of all Member States and it is chaired by a representative of the European Commission.

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. The Annex VIII of Medical Device Regulation (EU 2017/745) defines rules for the medical device classification.

Released MDCG-guidance provides support on how to carry out classification for devices. Additionally, guidance provides definitions for terms not defined in the Regulation such as terms “local dispersion”, “wholly or mainly absorbed”.

The existing classification rules in Annex VIII of MD Regulation will adequately classify most of the existing devices, but for some devices, classification can be difficult despite the classification rules. To support the classification, the MDCG 2021-24 document provides practical examples of devices, including applicable rules and classifications.

Check out the guidance document from EU-commission webpage: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf