{"id":6226,"date":"2021-11-29T09:16:26","date_gmt":"2021-11-29T08:16:26","guid":{"rendered":"https:\/\/medtech-ingenieur.de\/?p=6226"},"modified":"2021-11-29T09:16:26","modified_gmt":"2021-11-29T08:16:26","slug":"klassifizierung-von-medizinprodukten-i-ii-oder-iii","status":"publish","type":"post","link":"https:\/\/medtech-ingenieur.de\/en\/klassifizierung-von-medizinprodukten-i-ii-oder-iii\/","title":{"rendered":"Classification of medical devices I, II or III"},"content":{"rendered":"<p>1, 2 or 3 is not only the question in a well-known quiz show for children on public television, but also for companies that want to place a medical device on the market in the EU.<\/p>\n<p>The MDR provides for classes I, IIa, IIb, and 3 in Article 51. In addition, three further classes come into play in Article 52 (7 a, b, and c).<\/p>\n<ul>\n<li>Is: for sterile products<\/li>\n<li>In: for products with measuring function and<\/li>\n<li>Ir: for reusable surgical products<\/li>\n<\/ul>\n<p>Medical devices are classified using a risk-based system that considers the vulnerability of the human body and the potential risks associated with the devices. This approach uses a range of criteria to determine classification. These include, for example, the duration of contact with the body, the degree of invasiveness, the local or systemic effect, the potential toxicity, the part of the body affected by the use of the device, and whether or not the device is dependent on an energy source. These criteria can then be applied to a wide variety of medical devices and technologies.<br \/>\nThese classification rules are set out in Annex VIII to the Medical Device Regulation (EU) 2017\/745 (MDR).<\/p>\n<p>To put it simply, the effort required for product approval increases with the higher the product risk.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-6229 size-medium\" src=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/11\/ProductClassification-1-300x300.png\" alt=\"\" width=\"300\" height=\"300\" srcset=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/11\/ProductClassification-1-300x300.png 300w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/11\/ProductClassification-1-150x150.png 150w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/11\/ProductClassification-1-100x100.png 100w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/11\/ProductClassification-1-200x200.png 200w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/11\/ProductClassification-1-450x449.png 450w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/11\/ProductClassification-1-600x599.png 600w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2021\/11\/ProductClassification-1.png 605w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>In addition to Annex VIII of the MDR, there is now also a guide from the Medical Device Coordination Group. The MDCG 2021-24 Guidance on Classification of Medical Devices, published in October 2021, provides interested readers with detailed, 57-page guidance with clear decision-making rules and examples. I therefore highly recommend this document to anyone involved in product classification.<br \/>\nYou can download the document at the following link.<\/p>\n<p><a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_sector\/docs\/mdcg_2021-24_en.pdf\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_sector\/docs\/mdcg_2021-24_en.pdf<\/a><\/p>\n<p>Do you need support or advice in developing your medical device? Then please feel free to contact us. Our experienced MEDtech engineers will be happy to help you develop your medical device or clarify any questions you may have.<\/p>\n<p>Best regards<br \/>\nGoran Madzar<\/p>","protected":false},"excerpt":{"rendered":"<p>1, 2 oder 3 ist nicht nur die Frage bei einer bekannten Quizshow f\u00fcr Kinder im \u00f6ffentlich rechtlichen Fernsehen, sondern auch f\u00fcr Unternehmen, die ein Medizinprodukt in der EU in Verkehr bringen wollen. Die MDR sieht in Artikel 51 die Klassen I, IIa, IIb und 3 vor. Zus\u00e4tzlich kommen in Artikel 52 (7 a, b [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6227,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,14],"tags":[571,575,576,577,572,573,574,570,569,42,420,116],"class_list":["post-6226","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-dokumentation","category-normen","tag-i","tag-iia","tag-iib","tag-iii","tag-im","tag-ir","tag-is","tag-klassifizierung","tag-mdcg","tag-mdr","tag-medizinprodukt","tag-produkt","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>Klassifizierung von Medizinprodukten I, II oder III - 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\/klassifizierung-von-medizinprodukten-i-ii-oder-iii\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Klassifizierung von Medizinprodukten I, II oder III - MEDtech Ingenieur GmbH\" \/>\n<meta property=\"og:description\" content=\"1, 2 oder 3 ist nicht nur die Frage bei einer bekannten Quizshow f\u00fcr Kinder im \u00f6ffentlich rechtlichen Fernsehen, sondern auch f\u00fcr Unternehmen, die ein Medizinprodukt in der EU in Verkehr bringen wollen. 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