Public Healthhttps://health.ec.europa.eu/system/files/2023-06/mdcg_2022-5_en.pdf[PDF]MDCG 2022 – 5 Rev. 1 - Public Health2024年10月29日 · Medical Device Coordination Group Document MDCG 2022 – 5 Rev. 1 Page 1 of 28. MDCG 2022 – 5 Rev. 1 . Guidance on borderline between medical . devices and medicinal products under . ... 21 3.2 Medical devices consisting of a substance or mixture of substances used in vitro in direct contact with human cells,