{"id":34405,"date":"2022-05-25T10:38:00","date_gmt":"2022-05-25T09:38:00","guid":{"rendered":"https:\/\/faus-moliner.com\/la-frontera-de-los-productos-sanitarios\/"},"modified":"2023-12-04T12:28:34","modified_gmt":"2023-12-04T11:28:34","slug":"la-frontera-de-los-productos-sanitarios","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/en\/la-frontera-de-los-productos-sanitarios\/","title":{"rendered":"The medical devices frontier"},"content":{"rendered":"\n<p>The European Commission has released a new guide to delineate the concept of a medical device, which is essential in order to correctly classify a product and apply the appropriate legal regime to it. The boundary between medicinal product and medical device is sometimes complex.\u00a0<\/p>\n\n\n\n<p>A medical device is defined as: any instrument, device, equipment, software, implant, reagent, material or other article intended by the manufacturer to be used for a specific set of medical purposes (listed in the guidelines)and which exerts its principal action by mechanisms other than pharmacological, immunological or metabolic.<\/p>\n\n\n\n<p>The guidance elaborates on the meaning of all these elements by defining:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>specific medical purpose: it is identified by the manufacturer among those listed by the applicable rules;<\/li>\n\n\n\n<li>principal mode of action: it is described by the manufacturer (labelling and claims);<\/li>\n\n\n\n<li>pharmacological means: interaction typically at a molecular level between a substance or its metabolites and a constituent of the human body which results in initiation, enhancement, reduction or blockade of physiological functions or pathological processes.;<\/li>\n\n\n\n<li>immunological means: action initiated by a substance or its metabolites in the human body and mediated by cells or molecules involved in the immune system;<\/li>\n\n\n\n<li>metabolic means: action of a substance or its metabolites involving an alteration, including stopping, starting or changing the rate, extent or nature of a biochemical process (physiological or pharmacological), participating in, and available for, function of the human body;<\/li>\n\n\n\n<li>medical diagnosis: the process of investigating the anatomy, morphology, condition or functions of the human body and then interpreting the information to determine abnormalities.<\/li>\n<\/ul>\n\n\n\n<p>The Guidance incorporates a flowchart for determining if a product fulfils the definition of a medical device. According to the Commission, three questions must be asked: (i) is the product intended to be used for one of the listed medical purposes; (ii) if so, is it used or administered to make a medical diagnosis? If yes, then it is a medicinal product, otherwise the third question; (iii) is its principal action exerted by pharmacological, metabolic or immunological means? If yes, then it is a medical device.<\/p>\n\n\n\n<p>Finally, certain more complex classes of products are analysed, providing rules and examples to determine their status: (i) herbal products, (ii) substance-based medical devices (products based on substances used in vitro in contact with human cells, tissues, organs or embryos or; products based on substances intended to be introduced into the human body or applied to the skin) and; (iii) medical device and medicinal product combinations (integral combinations of medical devices and medicinal products; medical devices to administer medicinal products and; products comprising a medicinal product with an ancillary function).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The European Commission has released a new guide to delineate the concept of a medical device, which is essential in order to correctly classify a product and apply the appropriate legal regime to it. The boundary between medicinal product and medical device is sometimes complex.\u00a0 A medical device is defined as: any instrument, device, equipment,&#8230; <\/p>\n<div class=\"clear\"><\/div>\n<p><a href=\"https:\/\/faus-moliner.com\/en\/la-frontera-de-los-productos-sanitarios\/\" class=\"excerpt-read-more\">Read More<\/a><\/p>\n","protected":false},"author":28,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[72,86,1],"tags":[],"coauthors":[532],"class_list":["post-34405","post","type-post","status-publish","format-standard","hentry","category-capsulas-en","category-pharmaceutical-and-life-sciences-law","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The medical devices frontier - Faus Moliner<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/faus-moliner.com\/en\/la-frontera-de-los-productos-sanitarios\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The medical devices frontier - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"The European Commission has released a new guide to delineate the concept of a medical device, which is essential in order to correctly classify a product and apply the appropriate legal regime to it. The boundary between medicinal product and medical device is sometimes complex.\u00a0 A medical device is defined as: any instrument, device, equipment,... 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