{"id":10580,"date":"2026-07-24T13:13:27","date_gmt":"2026-07-24T13:13:27","guid":{"rendered":"https:\/\/www.essecieffe.it\/implantable-devices-and-class-iii-devices-delegated-regulation-eu-2026-1451\/"},"modified":"2026-09-02T13:36:49","modified_gmt":"2026-09-02T13:36:49","slug":"implantable-devices-and-class-iii-devices-delegated-regulation-eu-2026-1451","status":"publish","type":"post","link":"https:\/\/www.essecieffe.it\/en\/implantable-devices-and-class-iii-devices-delegated-regulation-eu-2026-1451\/","title":{"rendered":"Implantable devices and class III devices: Delegated Regulation (EU) 2026\/1451"},"content":{"rendered":"

With the publication of Delegated Regulation (EU) 2026\/1451<\/strong><\/span>, the European Commission expands the list of<\/span><\/span> implantable devices and class III <\/strong>devices that may benefit from the exemption from the requirement to perform a clinical investigation, provided they are based on Well-Established Technologies (WET).<\/strong><\/span> <\/p>\n

SCF has prepared a focus<\/a> piece to delve into a key point that must not be misunderstood: the exemption applies exclusively to the clinical investigation and does not remove the obligation to demonstrate the clinical conformity of the device<\/strong><\/p>\n

Manufacturers must continue to:
\ud83d\udd39 plan and document the clinical evaluation;
\ud83d\udd39 gather sufficient clinical evidence;
\ud83d\udd39 demonstrate safety, performance, and a favorable benefit-risk ratio in accordance with Regulation (EU) 2017\/745.<\/p>\n

The Commission’s message is clear: lower administrative burdens where clinical experience is well established, but zero compromises on patient safety.<\/strong><\/p>\n

For many companies, this update represents an opportunity to optimize development time and costs, but it will still require a well-structured regulatory and clinical strategy to demonstrate compliance with MDR requirements.<\/span><\/p>\n

Ecco la traduzione adatta per chiudere il testo in modo efficace e d’impatto:
The real game-changer isn’t doing less, but proving better when existing clinical evidence is already sufficient!<\/span><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

With the publication of Delegated Regulation (EU) 2026\/1451, the European Commission expands the list of implantable devices and class III devices that may benefit from the exemption from the requirement to perform a clinical investigation, provided they are based on Well-Established Technologies (WET). SCF has prepared a focus piece to delve into a key point…<\/p>\n","protected":false},"author":5,"featured_media":10484,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[23],"tags":[40],"class_list":["post-10580","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-focus","tag-medicaldevice"],"acf":[],"yoast_head":"\nImplantable devices and class III devices: Delegated Regulation (EU) 2026\/1451 - Studio Consulenza Farmacologica<\/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:\/\/www.essecieffe.it\/en\/implantable-devices-and-class-iii-devices-delegated-regulation-eu-2026-1451\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Implantable devices and class III devices: Delegated Regulation (EU) 2026\/1451 - Studio Consulenza Farmacologica\" \/>\n<meta property=\"og:description\" content=\"With the publication of Delegated Regulation (EU) 2026\/1451, the European Commission expands the list of implantable devices and class III devices that may benefit from the exemption from the requirement to perform a clinical investigation, provided they are based on Well-Established Technologies (WET). SCF has prepared a focus piece to delve into a key point...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.essecieffe.it\/en\/implantable-devices-and-class-iii-devices-delegated-regulation-eu-2026-1451\/\" \/>\n<meta property=\"og:site_name\" content=\"Studio Consulenza Farmacologica\" \/>\n<meta property=\"article:published_time\" content=\"2026-07-24T13:13:27+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-02T13:36:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.essecieffe.it\/wp-content\/uploads\/2025\/12\/immagine-scf-news-9.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"683\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Emanuele Bertino\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Emanuele Bertino\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.essecieffe.it\\\/en\\\/implantable-devices-and-class-iii-devices-delegated-regulation-eu-2026-1451\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.essecieffe.it\\\/en\\\/implantable-devices-and-class-iii-devices-delegated-regulation-eu-2026-1451\\\/\"},\"author\":{\"name\":\"Emanuele Bertino\",\"@id\":\"https:\\\/\\\/www.essecieffe.it\\\/#\\\/schema\\\/person\\\/257c57107e36fd56832d254997e77aa7\"},\"headline\":\"Implantable devices and class III devices: Delegated Regulation (EU) 2026\\\/1451\",\"datePublished\":\"2026-07-24T13:13:27+00:00\",\"dateModified\":\"2026-09-02T13:36:49+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.essecieffe.it\\\/en\\\/implantable-devices-and-class-iii-devices-delegated-regulation-eu-2026-1451\\\/\"},\"wordCount\":200,\"publisher\":{\"@id\":\"https:\\\/\\\/www.essecieffe.it\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.essecieffe.it\\\/en\\\/implantable-devices-and-class-iii-devices-delegated-regulation-eu-2026-1451\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.essecieffe.it\\\/wp-content\\\/uploads\\\/2025\\\/12\\\/immagine-scf-news-9.png\",\"keywords\":[\"MedicalDevice\"],\"articleSection\":[\"Focus\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.essecieffe.it\\\/en\\\/implantable-devices-and-class-iii-devices-delegated-regulation-eu-2026-1451\\\/\",\"url\":\"https:\\\/\\\/www.essecieffe.it\\\/en\\\/implantable-devices-and-class-iii-devices-delegated-regulation-eu-2026-1451\\\/\",\"name\":\"Implantable devices and class III devices: Delegated Regulation (EU) 2026\\\/1451 - 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