There has been an update to the guidance document MDCG 2022-5 concerning guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. The update includes the addition of products specifically intended for the cleaning, disinfection or sterilisation of medical devices in section 1.2.6.1 to the list of examples of medical devices. According to this guidance document, such devices should be qualified as medical devices.
The updated guidance can be accessed using the following link
