{"id":2315,"date":"2026-04-28T09:07:48","date_gmt":"2026-04-28T09:07:48","guid":{"rendered":"https:\/\/theemcnews.co.uk\/?page_id=2315"},"modified":"2026-04-28T09:08:58","modified_gmt":"2026-04-28T09:08:58","slug":"eu-harmonised-standards-for-medical-devices","status":"publish","type":"page","link":"https:\/\/theemcnews.co.uk\/index.php\/eu-harmonised-standards-for-medical-devices\/","title":{"rendered":"EU Harmonised Standards for Medical Devices"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"2315\" class=\"elementor elementor-2315\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9fc2c8a e-flex e-con-boxed e-con e-parent\" data-id=\"9fc2c8a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c8422c8 elementor-widget elementor-widget-image\" data-id=\"c8422c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1920\" height=\"1080\" src=\"https:\/\/theemcnews.co.uk\/wp-content\/uploads\/2026\/04\/2-1.png\" class=\"attachment-full size-full wp-image-2293\" alt=\"\" srcset=\"https:\/\/theemcnews.co.uk\/wp-content\/uploads\/2026\/04\/2-1.png 1920w, https:\/\/theemcnews.co.uk\/wp-content\/uploads\/2026\/04\/2-1-300x169.png 300w, https:\/\/theemcnews.co.uk\/wp-content\/uploads\/2026\/04\/2-1-1024x576.png 1024w, https:\/\/theemcnews.co.uk\/wp-content\/uploads\/2026\/04\/2-1-768x432.png 768w, https:\/\/theemcnews.co.uk\/wp-content\/uploads\/2026\/04\/2-1-1536x864.png 1536w, https:\/\/theemcnews.co.uk\/wp-content\/uploads\/2026\/04\/2-1-600x338.png 600w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-23b04a9 e-flex e-con-boxed e-con e-parent\" data-id=\"23b04a9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bd64180 elementor-widget elementor-widget-text-editor\" data-id=\"bd64180\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Harmonised standards under the Regulations on medical devices and in vitro diagnostic medical devices\u00a0are developed by CEN and CENELEC as European standardisation organisations, on the basis of a standardisation request issued by the Commission according to\u00a0<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:32012R1025\">Regulation (EU) No 1025\/2012<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>.<\/p><p>Once their references are published by the Commission in the\u00a0<a href=\"https:\/\/eur-lex.europa.eu\/oj\/direct-access.html\">Official Journal of the European Union<\/a>, the voluntary use of those standards confer presumption of conformity with the requirements of the Regulations they aim to cover.<\/p><p>The Commission issued a standardisation request to CEN and CENELEC on 14 April 2021. It is available in the \u201ceNorm Platform &#8211; European Commission standardisation requests\u201d as\u00a0<a href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/enorm\/mandate\/575_en\">M\/575<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>\u00a0(<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/fd0618d9-2606-4881-91d0-28ada2ae676c_en?filename=c_2021_2406_annex_en.pdf\">EN version<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>\u00a0&#8211; FR and DE available, clicking on the linguistic icon).<\/p><p>A first amendment to the standardisation request was adopted on 31 January 2023, available as\u00a0<a href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/enorm\/mandate\/575Amd1_en\">M\/575 Amd 1<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>\u00a0in the\u00a0<a href=\"https:\/\/ec.europa.eu\/transparency\/documents-register\/detail?ref=C(2023)694&amp;lang=en\">EN, FR and DE versions<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>. A second amendment to the standardisation request was adopted on 27 May 2024, available as\u00a0<a href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/enorm\/mandate\/575Amd2_en\">M\/575 Amd 2<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>\u00a0in the\u00a0<a href=\"https:\/\/ec.europa.eu\/transparency\/documents-register\/detail?ref=C(2024)3371&amp;lang=en\">EN, FR and DE versions<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>.<\/p><p>A consolidated version of the standardisation request M\/575, for information purposes only, is available\u00a0<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/6eb9d1d8-7d9c-4442-9016-1eb84ab8492f_en?filename=md_mdr-ivdr-consolidated-stand-req-m-575.pdf\">here<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>.<\/p><p>The publications in the OJEU of references of harmonised standards under the medical devices regulations are available:<\/p><p>For\u00a0<a class=\"ecl-link\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02017R0745-20250110\">Regulation (EU) 2017\/745<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>\u00a0on medical devices:<\/p><ul><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2026\/760\/oj\">Commission Implementing Decision (EU) 2026\/760<\/a>\u00a0of 1 April 2026<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2026\/193\/oj\">Commission Implementing Decision (EU) 2026\/193<\/a>\u00a0of 28 January 2026\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2025\/2078\/oj\">Commission Implementing Decision (EU) 2025\/2078<\/a>\u00a0of 17 October 2025<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2025\/681\/oj\">Commission Implementing Decision (EU) 2025\/681<\/a>\u00a0of 8 April 2025<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2024\/2631\/oj\">Commission Implementing Decision (EU) 2024\/2631<\/a>\u00a0of 8 October 2024<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2024\/815\/oj\">Commission Implementing Decision (EU) 2024\/815<\/a>\u00a0of 6 March 2024<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2023\/1410\/oj\">Commission Implementing Decision (EU) 2023\/1410<\/a>\u00a0of 4 July 2023<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/757\/oj\"><u>Commission Implementing Decision (EU) 2022\/757<\/u><\/a>\u00a0of 11 May 2022 \u00a0<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:32022D0006\">Commission Implementing Decision (EU) 2022\/6<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>\u00a0of 4 January 2022<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2021\/1182\/oj\">Commission Implementing Decision (EU) 2021\/1182<\/a>\u00a0of 16 July 2021<\/li><\/ul><p>For\u00a0<a class=\"ecl-link\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02017R0746-20250110\">Regulation (EU) 2017\/746<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>\u00a0on in vitro diagnostic medical devices:<\/p><ul><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2026\/197\/oj\">Commission Implementing Decision (EU) 2026\/197<\/a>\u00a0of 28 January 2026\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2025\/679\/oj\">Commission Implementing Decision (EU) 2025\/679<\/a>\u00a0of 8 April 2025<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2024\/2625\/oj\">Commission Implementing Decision (EU) 2024\/2625<\/a>\u00a0of 8 October 2024\u00a0\u00a0\u00a0<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2024\/817\/oj\">Commission Implementing Decision (EU) 2024\/817<\/a>\u00a0of 6 March 2024<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2023\/1411\/oj\">Commission Implementing Decision (EU) 2023\/1411<\/a>\u00a0of 4 July 2023<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/729\/oj\"><u>Commission Implementing Decision (EU) 2022\/729<\/u><\/a>\u00a0of 11 May 2022 \u00a0<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/15\/oj\">Commission Implementing Decision (EU) 2022\/15<\/a>\u00a0of 6 January 2022<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2021\/1195\/oj\">Commission Implementing Decision (EU) 2021\/1195<\/a>\u00a0of 19 July 2021<\/li><\/ul><p>Summary \/ consolidated lists of the above publications are available on the standardisation webpages on healthcare engineering:\u00a0<a class=\"ecl-link\" href=\"https:\/\/single-market-economy.ec.europa.eu\/single-market\/european-standards\/harmonised-standards\/medical-devices_en\">Medical devices<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>,\u00a0<a class=\"ecl-link\" href=\"https:\/\/single-market-economy.ec.europa.eu\/single-market\/european-standards\/harmonised-standards\/iv-diagnostic-medical-devices_en\">In vitro diagnostic medical devices<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>.<\/p><p>For more information on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, see the guidance document\u00a0<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/59ac4cb0-f187-4ca2-814d-82c42cde5408_en?filename=md_mdcg_2021_5_en.pdf\">MDCG 2021-5 rev.1 Guidance on standardisation for medical devices<\/a><button class=\"wt-unselected wt-laco wt-laco--button wt-offprint\" title=\"Search for available translations\" type=\"button\" aria-controls=\"laco-modal\"><\/button>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Harmonised standards under the Regulations on medical devices and in vitro diagnostic medical devices\u00a0are developed by CEN and CENELEC as European standardisation organisations, on the basis of a standardisation request issued by the Commission according to\u00a0Regulation (EU) No 1025\/2012. Once their references are published by the Commission in the\u00a0Official Journal&hellip; <\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-2315","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/theemcnews.co.uk\/index.php\/wp-json\/wp\/v2\/pages\/2315","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/theemcnews.co.uk\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/theemcnews.co.uk\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/theemcnews.co.uk\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/theemcnews.co.uk\/index.php\/wp-json\/wp\/v2\/comments?post=2315"}],"version-history":[{"count":4,"href":"https:\/\/theemcnews.co.uk\/index.php\/wp-json\/wp\/v2\/pages\/2315\/revisions"}],"predecessor-version":[{"id":2319,"href":"https:\/\/theemcnews.co.uk\/index.php\/wp-json\/wp\/v2\/pages\/2315\/revisions\/2319"}],"wp:attachment":[{"href":"https:\/\/theemcnews.co.uk\/index.php\/wp-json\/wp\/v2\/media?parent=2315"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}