{"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-1335476536\">\n\n\t<div id=\"col-1824713805\" 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>Die Koordinierungsgruppe f\u00fcr Medizinprodukte (MDCG), ein Expertengremium der EU-Mitgliedstaaten und der EU-Kommission, ver\u00f6ffentlichte am 20. Oktober einen Leitfaden f\u00fcr Hersteller, Importeure und H\u00e4ndler von Altprodukten, in dem die Pflichten gem\u00e4\u00df der Medizinprodukteverordnung (MDR) erl\u00e4utert werden. Die Verordnung (EU) 2017\/745 \u00fcber Medizinprodukte (MDR) sieht vor, dass bestimmte, nach dieser Verordnung zertifizierte Produkte \u2026<\/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 v28.0 (Yoast SEO v28.3) - 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. 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