{"id":3040,"date":"2021-11-23T11:27:23","date_gmt":"2021-11-23T03:27:23","guid":{"rendered":"https:\/\/regask.com\/?p=3040"},"modified":"2024-11-01T06:01:23","modified_gmt":"2024-10-31T22:01:23","slug":"eu-leitfaden-fur-altgerate","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/eu-legacy-devices-guidance\/","title":{"rendered":"EU: MDCG ver\u00f6ffentlicht Leitliniendokument zu \u201eLegacy Dev\u2026\u201c"},"content":{"rendered":"<p>Der <a href=\"https:\/\/www.eumonitor.eu\/9353000\/1\/j9vvik7m1c3gyxp\/vkkx77lllly9\" target=\"_blank\" rel=\"noopener\">Koordinierungsgruppe f\u00fcr Medizinprodukte<\/a> (MDCG), das Expertengremium der EU-Mitgliedstaaten und der EU-Kommission, hat am 20. Oktober ein Leitfadendokument f\u00fcr Hersteller, Importeure und H\u00e4ndler von \u201eAltger\u00e4ten\u201c ver\u00f6ffentlicht, in dem aufgef\u00fchrt wird, welche MDR-Verpflichtungen sie einhalten m\u00fcssen.<\/p>\n<p>Die Medizinprodukteverordnung 2017\/745 (MDR) sieht vor, dass bestimmte Ger\u00e4te, die unter der vorherigen Richtlinie (Medizinprodukterichtlinie 93\/42\/EWG) zertifiziert wurden, f\u00fcr einen \u00dcbergangszeitraum nach dem Geltungsbeginn der MDR am 26. Mai 2021 weiterhin auf dem EU-Markt in Verkehr gebracht und verkauft werden d\u00fcrfen, ohne dass diese Produkte speziell unter der MDR zertifiziert sind, vorausgesetzt, dass die MDR-Regeln hinsichtlich \u00dcberwachung und Vigilanz eingehalten werden k\u00f6nnen.<\/p>\n<p>Die Leitlinien enthalten detaillierte Informationen zum Umfang der regelm\u00e4\u00dfigen Sicherheitsaktualisierungsberichte, die erstellt und eingereicht werden m\u00fcssen, sowie zur Tatsache, dass f\u00fcr solche Altger\u00e4te keine f\u00fcr die Einhaltung gesetzlicher Vorschriften verantwortliche Person (PRRC) ernannt werden muss.<\/p>\n<p>Kontaktieren Sie RegASK, um mehr \u00fcber \u00c4nderungen der Vorschriften f\u00fcr Medizinprodukte zu erfahren. <a href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" rel=\"noopener\">Nehmen Sie Kontakt mit den Experten von RegASK auf.<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_sector\/docs\/md_mdcg_2021_25_en.pdf\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1595752783\">\n\n\t<div id=\"col-1588708263\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/de\/fallstudien\/ressourcen-fallstudien-medizinprodukte\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Medizinger\u00e4tebranche<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>The Medical Devices Coordination Group (MDCG) which is the expert panel of the EU Member States and the EU Commission published on 20 October a Guidance Document for manufacturers, importers, and distributors of &#8220;legacy devices&#8221; on which MDR obligations they must comply with. The Medical Devices Regulation 2017\/745 (MDR) provides that certain devices certified under&#8230;<\/p>","protected":false},"author":39,"featured_media":2754,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-3040","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU: Legacy Devices Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"The EU MDCG publishes a guidance document on legacy devices. Stay compliant with RegASK&#039;s expert analysis.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/de\/eu-leitfaden-fur-altgerate\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: MDCG Publish Guidance Document on &quot;Legacy Devices&quot;\" \/>\n<meta property=\"og:description\" content=\"The EU MDCG publishes a guidance document on legacy devices. Stay compliant with RegASK&#039;s expert analysis.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/eu-leitfaden-fur-altgerate\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2021-11-23T03:27:23+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-31T22:01:23+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/04\/medical-device-diabetes-blood-test-1.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/eu-legacy-devices-guidance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eu-legacy-devices-guidance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"EU: MDCG Publish Guidance Document on &#8220;Legacy Dev&hellip;\",\"datePublished\":\"2021-11-23T03:27:23+00:00\",\"dateModified\":\"2024-10-31T22:01:23+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eu-legacy-devices-guidance\\\/\"},\"wordCount\":247,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eu-legacy-devices-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/medical-device-diabetes-blood-test-1.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"de\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/eu-legacy-devices-guidance\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/eu-legacy-devices-guidance\\\/\",\"name\":\"EU: Legacy Devices Guidance | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eu-legacy-devices-guidance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eu-legacy-devices-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/medical-device-diabetes-blood-test-1.png\",\"datePublished\":\"2021-11-23T03:27:23+00:00\",\"dateModified\":\"2024-10-31T22:01:23+00:00\",\"description\":\"The EU MDCG publishes a guidance document on legacy devices. 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