{"id":6389,"date":"2022-01-10T16:07:27","date_gmt":"2022-01-10T15:07:27","guid":{"rendered":"https:\/\/medtech-ingenieur.de\/?p=6389"},"modified":"2022-01-10T16:07:50","modified_gmt":"2022-01-10T15:07:50","slug":"neuer-anhang-a112021-fuer-en-iso-134852016","status":"publish","type":"post","link":"https:\/\/medtech-ingenieur.de\/en\/neuer-anhang-a112021-fuer-en-iso-134852016\/","title":{"rendered":"Annex A11:2021 of EN ISO 13485:2016"},"content":{"rendered":"<p>If you are also working in medical technology, you have probably already noticed that EN ISO 13485:2016 has a new annex:<\/p>\n<p><strong>EN ISO 13485:2016+A11:2021<\/strong><\/p>\n<p>Since we are also an EN ISO 13485 certified development service provider, we have taken a closer look at the changes.<\/p>\n<h3>What has changed?<\/h3>\n<p>The legal framework has changed with the introduction of the MDR (Regulation 2017\/745) and IVDR (Regulation 2017\/746). Since ISO 13485 is an international standard, the base standard remains unchanged. <img loading=\"lazy\" decoding=\"async\" class=\"wp-image-5494 alignleft\" src=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/05\/EU_MDR-294x300.png\" alt=\"\" width=\"134\" height=\"137\" srcset=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/05\/EU_MDR-294x300.png 294w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/05\/EU_MDR-100x102.png 100w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/05\/EU_MDR-150x153.png 150w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/05\/EU_MDR-200x204.png 200w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/05\/EU_MDR-300x306.png 300w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/05\/EU_MDR-450x459.png 450w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/05\/EU_MDR.png 588w\" sizes=\"auto, (max-width: 134px) 100vw, 134px\" \/> The legal requirements to be covered are usually specified in a separate information annex of a harmonised standard (1). These annexes are then called Annex ZA, ZB, or ZZ in the European standards.<\/p>\n<p>The changes therefore affect Annexes ZA and ZB and Annex A11:2021 contains these updated Annexes ZA and ZB.<br \/>\nAnnex ZA describes the relationship between EN ISO 13485 and the MDR, Annex ZB describes the relationship with the IVDR.<\/p>\n<p>EN ISO 13485 describes requirements for a quality management system, and accordingly, it does not cover all the requirements of the MDR or IVDR. Depending on your role within the MDR or IVDR, you may need to fill in the gaps. However, thanks to Annexes ZA and ZB, these are easy to find.<\/p>\n<p>Best regards,<\/p>\n<p>Martin Bosch<\/p>\n<p>&nbsp;<\/p>\n<h3>Left<\/h3>\n<p>(1) <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/PDF\/?uri=CELEX:52016XC0726(02)\">https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/PDF\/?uri=CELEX:52016XC0726(02)<\/a>The Blue Guide describes in more detail what \u201charmonised\u201d means in the context of standards.<\/p>\n<p>(2) <a href=\"https:\/\/www.beuth.de\/de\/norm\/din-en-iso-13485\/332674603\">https:\/\/www.beuth.de\/de\/norm\/din-en-iso-13485\/332674603<\/a>, Link to the Beuth Verlag website with the new edition DIN EN ISO 13485:2021-12.<\/p>","protected":false},"excerpt":{"rendered":"<p>Falls Sie auch in der Medizintechnik t\u00e4tig sind, dann haben Sie wahrscheinlich schon mitbekommen, dass die EN ISO 13485:2016 einen neuen Anhang hat: EN ISO 13485:2016+A11:2021 Da wir auch EN ISO 13485 zertifizierter Entwicklungsdienstleister sind, haben wir uns die \u00c4nderungen n\u00e4her angeschaut. Was hat sich ge\u00e4ndert? Der rechtliche Rahmen hat sich mit der Einf\u00fchrung der [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":5494,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[298],"class_list":["post-6389","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-normen","tag-iso13485","post-wrapper","thrv_wrapper"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Anhang A11:2021 der EN ISO 13485:2016 - MEDtech Ingenieur GmbH<\/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:\/\/medtech-ingenieur.de\/en\/neuer-anhang-a112021-fuer-en-iso-134852016\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Anhang A11:2021 der EN ISO 13485:2016 - MEDtech Ingenieur GmbH\" \/>\n<meta property=\"og:description\" content=\"Falls Sie auch in der Medizintechnik t\u00e4tig sind, dann haben Sie wahrscheinlich schon mitbekommen, dass die EN ISO 13485:2016 einen neuen Anhang hat: EN ISO 13485:2016+A11:2021 Da wir auch EN ISO 13485 zertifizierter Entwicklungsdienstleister sind, haben wir uns die \u00c4nderungen n\u00e4her angeschaut. 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Der rechtliche Rahmen hat sich mit der Einf\u00fchrung der [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/medtech-ingenieur.de\/en\/neuer-anhang-a112021-fuer-en-iso-134852016\/\" \/>\n<meta property=\"og:site_name\" content=\"MEDtech Ingenieur GmbH\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/medtechIngenieur\" \/>\n<meta property=\"article:author\" content=\"https:\/\/www.facebook.com\/medtechIngenieur\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-01-10T15:07:27+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-01-10T15:07:50+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/05\/EU_MDR.png\" \/>\n\t<meta property=\"og:image:width\" content=\"588\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Martin Bosch\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@https:\/\/twitter.com\/MedtechIng\" \/>\n<meta name=\"twitter:site\" content=\"@MedtechIng\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Martin Bosch\" \/>\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:\\\/\\\/medtech-ingenieur.de\\\/neuer-anhang-a112021-fuer-en-iso-134852016\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/neuer-anhang-a112021-fuer-en-iso-134852016\\\/\"},\"author\":{\"name\":\"Martin Bosch\",\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/#\\\/schema\\\/person\\\/4a6ce76ff044f5fc88a30484c695fd84\"},\"headline\":\"Anhang A11:2021 der EN ISO 13485:2016\",\"datePublished\":\"2022-01-10T15:07:27+00:00\",\"dateModified\":\"2022-01-10T15:07:50+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/neuer-anhang-a112021-fuer-en-iso-134852016\\\/\"},\"wordCount\":261,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/neuer-anhang-a112021-fuer-en-iso-134852016\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/medtech-ingenieur.de\\\/wp-content\\\/uploads\\\/2021\\\/05\\\/EU_MDR.png\",\"keywords\":[\"ISO13485\"],\"articleSection\":[\"Normen\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/medtech-ingenieur.de\\\/neuer-anhang-a112021-fuer-en-iso-134852016\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/neuer-anhang-a112021-fuer-en-iso-134852016\\\/\",\"url\":\"https:\\\/\\\/medtech-ingenieur.de\\\/neuer-anhang-a112021-fuer-en-iso-134852016\\\/\",\"name\":\"Anhang A11:2021 der EN ISO 13485:2016 - 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Sein Fachgebiet umfasst die Entwicklung von Embedded Elektronik, speziell f\u00fcr medizinische Anwendungen. Dabei liegt sein Fokus auf dem Design von Leiterplatten und Schaltungen, die sowohl Mikrocontroller als auch analoge Schaltungstechnik integrieren. Diese kommen in einer Vielzahl von Ger\u00e4ten zur Anwendung, von Blutanalyseger\u00e4ten bis hin zu Defibrillatoren.\",\"sameAs\":[\"https:\\\/\\\/www.medtech-ingenieur.de\",\"https:\\\/\\\/www.facebook.com\\\/medtechIngenieur\\\/\",\"https:\\\/\\\/x.com\\\/https:\\\/\\\/twitter.com\\\/MedtechIng\"],\"url\":\"https:\\\/\\\/medtech-ingenieur.de\\\/en\\\/author\\\/martin\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Anhang A11:2021 der EN ISO 13485:2016 - MEDtech Ingenieur GmbH","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/medtech-ingenieur.de\/en\/neuer-anhang-a112021-fuer-en-iso-134852016\/","og_locale":"en_US","og_type":"article","og_title":"Anhang A11:2021 der EN ISO 13485:2016 - MEDtech Ingenieur GmbH","og_description":"Falls Sie auch in der Medizintechnik t\u00e4tig sind, dann haben Sie wahrscheinlich schon mitbekommen, dass die EN ISO 13485:2016 einen neuen Anhang hat: EN ISO 13485:2016+A11:2021 Da wir auch EN ISO 13485 zertifizierter Entwicklungsdienstleister sind, haben wir uns die \u00c4nderungen n\u00e4her angeschaut. 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