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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 ]]> https://www.csdmed.mc/it/actualites/medical-devices-regulation/mdcg-2021-24-guidance-on-classification-of-medical-devices-56 https://www.csdmed.mc/it/actualites/medical-devices-regulation/mdcg-2021-24-guidance-on-classification-of-medical-devices-56 Fri, 07 Jan 2022 00:00:00 +0100
Il 9 dicembre 2021, il Medical Device Coordination Group (MDCG) ha pubblicato un nuovo documento di orientamento. Questo nuovo documento fornisce indicazioni sulle modifiche sostanziali delle indagini cliniche ai sensi del regolamento sui dispositivi medici (MDCG 2021-28). ]]> https://www.csdmed.mc/it/actualites/medical-devices-regulation/mdcg-2021-28-substantial-modification-of-clinical-investigation-under-medical-device-regulation-57 https://www.csdmed.mc/it/actualites/medical-devices-regulation/mdcg-2021-28-substantial-modification-of-clinical-investigation-under-medical-device-regulation-57 Thu, 13 Jan 2022 00:00:00 +0100
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