{"id":10372,"date":"2025-10-22T21:53:48","date_gmt":"2025-10-22T20:53:48","guid":{"rendered":"https:\/\/mcamps.com\/?p=10372"},"modified":"2026-04-30T13:02:26","modified_gmt":"2026-04-30T12:02:26","slug":"nuevo-real-decreto-de-productos-sanitarios-para-diagnostico-in-vitro","status":"publish","type":"post","link":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/nuevo-real-decreto-de-productos-sanitarios-para-diagnostico-in-vitro\/","title":{"rendered":"New Royal Decree on Medical Devices for in vitro diagnostics approved"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Yesterday, the Council of Ministers approved the text of the new <strong>Royal Decree on Medical Devices for in vitro diagnostics<\/strong>. This new <strong>RD 55\/2025 <\/strong>complements European legislation (<strong>Regulation (EU) 2017\/746<\/strong>) and allows it to be developed, in those points that are left in the hands of each member state of the European Union.  And therefore, this regulation will apply only within the Spanish national scope. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As the AEMPS informs us, in a <a href=\"https:\/\/www.aemps.gob.es\/informa\/el-consejo-de-ministros-aprueba-el-nuevo-real-decreto-de-productos-sanitarios-para-diagnostico-in-vitro\/\" target=\"_blank\" rel=\"noopener\">press release issued yesterday<\/a>, the new <strong>Royal Decree<\/strong> <strong>55\/2025<\/strong> delves into different aspects that the <strong>Regulation (EU) 2017\/746<\/strong> is left to each Member State. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Regulation allows member states to create their own legislation in the following areas: <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The determination of the competent authority for the purposes of the regulation and the establishment of the language regime.<\/li>\n\n\n\n<li>The manufacture of products for use in the health care facility itself (commonly referred to as the \"in-house\" or \"in-house\" production).\u00a0<em>in house<\/em>).<\/li>\n\n\n\n<li>Genetic testing, genetic information and the necessary pre- and post-test counselling.<\/li>\n\n\n\n<li>European reference laboratories.<\/li>\n\n\n\n<li>The characteristics of the marketing register in Spain.<\/li>\n\n\n\n<li>Diagnostic medical devices\u00a0<em>in vitro<\/em>\u00a0subject to prescription, eliminating the need for prescription for self-testing products and maintaining their sale exclusively through pharmacies or directly through the pharmacy's own website.<\/li>\n\n\n\n<li>National requirements for the authorisation of performance studies.<\/li>\n\n\n\n<li>Market surveillance and control obligations.<\/li>\n\n\n\n<li>Foreign trade requirements for economic operators.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>Royal Decree<\/strong> <strong>55\/2025<\/strong>, It also repeals the previous legislation in this area, i.e. the <strong>Royal Decree 1662\/2000, of 29 September 2000.<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>AEMPS organises an informative seminar on the new Royal Decree on Medical Devices for in vitro diagnosis<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>Spanish Agency for Medicines and Health Products (AEMPS)<\/strong>, which has been in charge of drafting this new Royal Decree on Medical Devices for in vitro diagnostics, has organised an informative session on the new law. <em>online <\/em>on the aspects regulated in the new text. At this information day, which will be held online on <strong>4 December<\/strong>, The new regulation will be presented to the main sectors involved, which have already been informed throughout the drafting and approval process of the new Royal Decree. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Registration for the event is now available and will also be available at\u00a0<em>streaming<\/em>\u00a0through the Linkedin and YouTube accounts of the AEMPS.<\/p>","protected":false},"excerpt":{"rendered":"<p>El Consejo de Ministros aprob\u00f3 ayer el texto del nuevo Real Decreto de Productos Sanitarios para diagn\u00f3stico in vitro. Este nuevo RD 55\/2025 complementa la normativa europea (Reglamento (UE) 2017\/746) y permite desarrollarla, en aquellos puntos que dejan en manos de cada estado miembro de la Uni\u00f3n Europea. Y por lo tanto, esta normativa aplicar\u00e1 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":10375,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[810,50,199],"tags":[287],"class_list":["post-10372","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislacion","category-noticias","category-productos-sanitarios","tag-productos-sanitarios"],"_links":{"self":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/posts\/10372","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/comments?post=10372"}],"version-history":[{"count":0,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/posts\/10372\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/media\/10375"}],"wp:attachment":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/media?parent=10372"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/categories?post=10372"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/tags?post=10372"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}