Al determinarse que tanto el EtO en botellón (sin marcado CE) como los cartuchos (con marcado CE) de EtO caen bajo el alcance de MDR/ IVDR y no de BPR en la MDCG 2024-13 en esta guia se actualiza estas referencias en la sección 1.2.6.1
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1.2.6 Examples
1.2.6.1 Examples of medical devices
The following examples should, in view of their principal mode of action, generally be considered as medical devices subject to the relevant criteria being met; the function of some of the devices indicated in these examples may be assisted by the presence of medicinal product where such substances have an ancillary action to that of the device.
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– Products specifically intended for the cleaning, disinfection or sterilisation of medical devices
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Interesante ….