{"id":33306,"date":"2024-11-22T11:34:37","date_gmt":"2024-11-22T10:34:37","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/11\/22\/aggiornamento-della-linea-guida-mdcg-2022-5-rev-1-chiarificazioni-sui-prodotti-borderline-tra-dispositivi-medici-e-medicinali\/"},"modified":"2024-11-22T11:56:58","modified_gmt":"2024-11-22T10:56:58","slug":"aggiornamento-della-linea-guida-mdcg-2022-5-rev-1-chiarificazioni-sui-prodotti-borderline-tra-dispositivi-medici-e-medicinali","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/11\/22\/aggiornamento-della-linea-guida-mdcg-2022-5-rev-1-chiarificazioni-sui-prodotti-borderline-tra-dispositivi-medici-e-medicinali\/","title":{"rendered":"MDCG Guideline 2022-5 Rev.1 Update: Clarification of Borderline Products between Medical Devices and Medicinal Products"},"content":{"rendered":"

22\/11\/2024<\/p>\n

In October 2024, the Medical Device Coordination Group (MDCG) published the updated version of MDCG Guideline 2022-5 Rev. 1<\/strong>, entitled ‘Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017\/745 on medical devices<\/strong>‘.<\/h2>\n

This guideline is a key reference point in the European Union for clarifying the regulatory distinctions between medical devices and medicinal products. This guideline helps the manufacturer to correctly classify borderline devices<\/strong>, which are those products that by their nature do not immediately relate to a specific sector, for which it is therefore difficult to define which regulation should be applied. In particular, the document refers to devices on the borderline between medical devices and medicines.<\/p>\n

Main Updates<\/h2>\n

MDCG guideline 2022-5 rev. 1 retains its importance in helping manufacturers and regulators determine whether a product should qualify as a medical device<\/strong> under MDR (EU) 2017\/745, or as a medicinal product<\/strong> under Directive 2001\/83\/EC and Regulation (EC) No. 726\/2004.<\/p>\n

In the October 2024 revision, specific updates <\/strong>were made to Section 1.2.6.1<\/strong>, concerning products intended for cleaning, disinfection or sterilisation of medical devices<\/strong>.<\/p>\n

The revision clarifies that products specifically intended for the cleaning, disinfection or sterilisation<\/strong> of medical devices can be classified as medical devices, according to MDR (EU) 2017\/745<\/strong>, if they are used as part of the preparation of the devices themselves. However, if the manufacturer has not specifically and solely<\/strong> intended them for such purposes (e.g. in the case of multi-purpose disinfectants), they are not covered by the Medical Device Regulation (MDR). The latter are instead covered by Regulation (EU) 528\/2012<\/strong> on biocidal products<\/strong>, which applies to products with a broader, non-specific use.<\/p>\n

The distinction is based on the main action of the substance<\/strong> involved and the manufacturer’s declared intent.<\/strong> If the action is primarily pharmacological or chemical, the product is considered a medicinal product; if, on the other hand, the action is ancillary or supportive of a device, it is considered a medical device.
\nIn the case of cleaning, disinfection or sterilisation products, to be considered medical devices they must have the sole intended use of preparing other medical devices<\/strong>.<\/p>\n

Impact on Companies and the Sector<\/h2>\n

The updates have direct implications for manufacturers, as they clarify the conditions under which a product is considered a medical device and not a biocidal product. This is particularly relevant for companies producing detergents and disinfectants for specific uses in medical devices<\/strong>.
\nThe clarification provided by the updated guideline will help facilitate manufacturers’ compliance with MDR requirements.<\/p>\n

The full version of the guide is available on the official website of the European Commission and can be consulted at the following link: MDCG 2022-5 Rev. 1 \u2013 Guidance on borderline between medical devices and medicinal products<\/strong><\/a>.<\/strong><\/p>\n

For more information on Borderline substance-based devices, read the article on our Blog<\/a>.<\/strong><\/p>\n

>>> THEMA, in collaboration with other Complife Group companies, offers integrated and comprehensive support for regulatory compliance and quality management of Borderline Medical Devices, particularly when supported by a medicinal product with ancillary function. For more information on the Borderline Service<\/strong>, please contact sales@complifegroup.com.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

22\/11\/2024 In October 2024, the Medical Device Coordination Group (MDCG) published the updated version of MDCG Guideline 2022-5 Rev. 1, entitled […]<\/p>\n","protected":false},"author":115,"featured_media":33295,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-33306","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"\nMDCG Guideline 2022-5 Rev.1 Update: Clarification of Borderline Products between Medical Devices and Medicinal Products - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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