EU – New and updated MDCG guidance documents

The MDCG has published one new and two revised guidance documents.
The new guidance MDCG 2024-13 addresses the regulatory status of ethylene oxide, especially the delineation between medical device and biocide. Guidance MDCG 2022-5 on borderline cases between medical device and medicinal product is now available in revision one, with the added case of products specifically intended for cleaning, disinfection and sterillisation of medical devices. Already in mid-October the MDCG updated guidance MDCG 2021-25 on the application of MDR requirements to “legacy deivices”. In Revision 1 the document was re-structured and substantially changed, taking into account the changes to the MDR.