[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-467083-105":59,"doc-detail-467083-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","substance-based-medical-device-in-wound-care-bridging-regulatory-clarity-and-therapeutic-innovation","Substance-Based Medical Device in Wound Care - Bridging Regulatory Clarity and Therapeutic Innovation","","Substance-based medical devices (SBMDs) are increasingly used in wound care thanks to their favorable safety profile, physicochemical mechanisms, and therapeutic effectiveness. These products often combine biopolymers such as hyaluronic acid or chitosan with antimicrobial agents, including silver nanoparticles or silver sulfadiazine, supporting hydration, tissue protection, and microbial burden control in acute and chronic wounds. Despite broad clinical use, MDR classification under Regulation (EU) 2017/745 remains highly debated. This review analyzes scientific and regulatory criteria for topical SBMDs, emphasizing MDR Annex VIII rules, guidance documents, and the decisive primary mode of action in qualifying products, while highlighting cross-country inconsistencies and the need for a harmonized framework.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/substance-based-medical-device-in-wound-care-bridging-regulatory-clarity-and-therapeutic-innovation/467083/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/substance-based-medical-device-in-wound-care-bridging-regulatory-clarity-and-therapeutic-innovation/467083.png","ImageObject",300,407,{"name":92,"@type":93},"Anna Hans","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-31","2026-09-30",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What types of substances are commonly used in substance-based medical devices for wound care?","Question",{"text":112,"@type":113},"SBMDs often incorporate biopolymers such as hyaluronic acid or chitosan, either alone or combined with antimicrobial agents like silver nanoparticles or silver sulfadiazine.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Why is regulatory classification of SBMDs under EU MDR considered challenging?",{"text":117,"@type":113},"The review explains that classification depends critically on identifying the primary mode of action, especially for products containing antimicrobial substances, which creates debate and inconsistent outcomes.",{"name":119,"@type":110,"acceptedAnswer":120},"Which MDR annex rules are highlighted as key for substance-based devices?",{"text":121,"@type":113},"The review focuses on MDR Annex VIII, specifically Rule 21 for substance-based devices and Rule 14 for devices incorporating medicinal substances with ancillary action, supported by guidance documents.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},467083,1790814387,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},5909892332657,"https://ap-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d","Review  \nSubstance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation  \nDaiana Ianev 1, Michela Mori 2,*, Barbara Vigani 1, Caterina Valentino 1, Marco Ruggeri 1, Giuseppina Sandri 1 and Silvia Rossi 1, *  \nAcademic Editor: Xiaowen Shi  \nReceived: 15 November 2025  \nRevised: 19 December 2025  \nAccepted: 29 December 2025  \nPublished: 31 December 2025  \nCopyright: © 2025 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license.  \n1 Department of Drug Sciences, University of Pavia, Viale Taramelli 12, 27100 Pavia, Italy;  \ndaiana.ianev01@universitadipavia.it (D.I.); [barbara.vigani@unipv.it](barbara.vigani@unipv.it) (B.V.); [caterina.valentino@unipv.it](caterina.valentino@unipv.it) (C.V.); [marco.ruggeri@unipv.it](marco.ruggeri@unipv.it) (M.R.); [giuseppina.sandri@unipv.it](giuseppina.sandri@unipv.it) (G.S.)  \n2 1Med SA, Via Campagna 13, 6982 Agno, Switzerland  \n* Correspondence: michela.mori@1med.ch (M.M.); [silvia.rossi@unipv.it](silvia.rossi@unipv.it) (S.R.)  \nAbstract  \nSubstance-based medical devices (SBMDs) are increasingly used in wound care due to their favorable safety profile, physicochemical mechanisms of action, and therapeutic effectiveness. These products often incorporate biopolymers such as hyaluronic acid or chitosan, alone or in combination with antimicrobial agents like silver nanoparticles (AgNPs) or silver sulfadiazine (SSD), offering hydration, tissue protection, and control of microbial burden in both acute and chronic wounds. Despite their widespread clinical use, the regulatory classification of SBMDs under Regulation (EU) 2017/745 (MDR) remains one of the most challenging and debated areas within the current European framework. This review analyzes the scientific and regulatory context of topical SBMDs, with particular emphasis on borderline products that share similarities with medicinal products in terms of formulation, composition, or claimed effects. The discussion focuses on the application of MDR Annex VIII, specifically Rule 21 for substance-based devices and Rule 14 for devices incorporating medicinal substances with ancillary action, together with interpretative guidance provided by MDCG 2022-5 Rev.1 and the Association of the European Self-Care Industry (AESGP) Position Paper. Particular attention is given to the identification of the critical role of the primary mode of action (MoA) as the determining criterion for regulatory qualification, especially for products containing antimicrobial substances. Through selected examples and case analyses, the review highlights inconsistencies in classification across Member States and underscores the need for a more harmonized, evidence-based, and proportionate regulatory approach. Overall, SBMDs challenge traditional regulatory boundaries and call for a framework capable of accommodating complex, multifunctional products while ensuring patient safety and regulatory coherence.  \nKeywords: substance-based medical device; medical device made of substance; topical; medicinal products; skin  \n1. Introduction  \nThe application of topical products in healthcare has deep historical roots, originating from ancient civilizations that utilized natural extracts and botanicals for therapeutic, protective, and cosmetic purposes [1] . Throughout the 20th century, advancements in pharmaceutical science, dermatology, and formulation technology significantly transformed topical products, facilitating the introduction of sophisticated dosage forms such as creams,  \ngels, ointments, and transdermal patches, designed to enhance bioavailability and controlled substance delivery [2] . Parallel to these technological advancements, the regulatory landscape also evolved to address the complexity and increasing overlap among medicinal products and medical devices, each governed by distinct European legislations: Di","cbCainCW4x4Jaq1Z","https://ap.wps.com/l/cbCainCW4x4Jaq1Z","pdf",1164179,21,"English","# Abstract\n# Keywords\n# 1. Introduction\n## Topical products in healthcare and historical development\n## Regulatory frameworks: medicinal products vs medical devices\n## Borderline products and the MDR complexity\n## Focus and scope: topical SBMDs and classification criteria","[{\"question\":\"What types of substances are commonly used in substance-based medical devices for wound care?\",\"answer\":\"SBMDs often incorporate biopolymers such as hyaluronic acid or chitosan, either alone or combined with antimicrobial agents like silver nanoparticles or silver sulfadiazine.\"},{\"question\":\"Why is regulatory classification of SBMDs under EU MDR considered challenging?\",\"answer\":\"The review explains that classification depends critically on identifying the primary mode of action, especially for products containing antimicrobial substances, which creates debate and inconsistent outcomes.\"},{\"question\":\"Which MDR annex rules are highlighted as key for substance-based devices?\",\"answer\":\"The review focuses on MDR Annex VIII, specifically Rule 21 for substance-based devices and Rule 14 for devices incorporating medicinal substances with ancillary action, supported by guidance documents.\"}]","Substance-Based Medical Device in Wound Care - Bridging Regulatory Clarity and Therapeutic Innovation | PDF",1790772290,53]