Update – MDCG 2021-24 rev.1 – Guidance on classification of medical devices (April 2026)
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 purpose of this chapter is to provide a general overview on the impact of the classification of medical devices on different aspects of the device compliance with the legal requirements.
Read the news announcement published by DG Health and Food Safety on 20 April 2026.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (13 mai 2026). Update – MDCG 2021-24 rev.1 – Guidance on classification of medical devices (April 2026). ELSIBI. Consulté le 11 octobre 2026 à l’adresse https://doi.org/10.58079/167np
