{"id":54202,"date":"2021-06-23T03:00:26","date_gmt":"2021-06-23T10:00:26","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?p=54202"},"modified":"2023-01-12T16:49:03","modified_gmt":"2023-01-13T00:49:03","slug":"mdr-challenges-remain-as-regulation-goes-into-effect-medtech-europe","status":"publish","type":"post","link":"https:\/\/www.jamasoftware.com\/legacy\/blog\/2021\/06\/23\/mdr-challenges-remain-as-regulation-goes-into-effect-medtech-europe\/","title":{"rendered":"MDR Challenges Remain as Regulation Goes Into Effect: MedTech Europe"},"content":{"rendered":"<h3><img decoding=\"async\" class=\"aligncenter size-full wp-image-54203\" src=\"https:\/\/www.jamasoftware.com\/media\/2021\/06\/2021-06-23_MDR-MedTech-Post-1024x512-1.jpg\" alt=\"\" width=\"1024\" height=\"512\" srcset=\"https:\/\/www.jamasoftware.com\/legacy\/media\/2021\/06\/2021-06-23_MDR-MedTech-Post-1024x512-1.jpg 1024w, https:\/\/www.jamasoftware.com\/legacy\/media\/2021\/06\/2021-06-23_MDR-MedTech-Post-1024x512-1-300x150.jpg 300w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/h3>\n<p><strong>Editor\u2019s Note:\u00a0<\/strong>This posts on EU MDR\u00a0was originally published\u00a0<a href=\"https:\/\/www.medtechdive.com\/news\/mdr-challenges-remain-as-regulation-goes-into-effect-medtech-europe\/600818\/\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a> by MedTech Drive and written by <a href=\"https:\/\/www.medtechdive.com\/editors\/gslabodkin\/\" target=\"_blank\" rel=\"noopener\">Greg Slabodkin<\/a>.<\/p>\n<hr \/>\n<h3>Dive Brief:<\/h3>\n<ul>\n<li>While the Medical Device Regulation&#8217;s May 26 go-live date marks a significant milestone, MedTech Europe\u00a0<a href=\"https:\/\/www.medtecheurope.org\/news-and-events\/press\/medtech-europe-welcomes-the-medical-device-regulations-entry-into-full-application-and-urges-continued-work-to-deploy-the-new-regulatory-system\/\" target=\"_blank\" rel=\"noopener\">warned in a statement<\/a>\u00a0that MDR challenges remain, limiting the industry\u2019s ability to &#8220;seamlessly supply certified devices under the new rules.&#8221;<\/li>\n<li>The European trade group contends that despite the EU MDR going into effect, &#8220;some key pillars&#8221; of the necessary infrastructure are &#8220;still not fully operational or even in place,&#8221; creating challenges in particular for many small and medium enterprises.<\/li>\n<li>CEO Serge Bernasconi\u00a0argued that the complexity of MDR and the delay in the new regulatory system&#8217;s full readiness is resulting in European patients &#8220;losing their previous opportunities to be the first to benefit from critical medical technology innovation.&#8221;<\/li>\n<\/ul>\n<div class=\" large medium article-body\">\n<h3>Dive Insight:<\/h3>\n<p>MedTech Europe had been\u00a0<a href=\"https:\/\/www.medtechdive.com\/news\/medtech-europe-pushes-urgent-action-to-keep-devices-on-sale-after-mdr\/570103\/\" target=\"_blank\" rel=\"noopener\">sounding the alarm<\/a>\u00a0for some time about MDR&#8217;s\u00a0potential to disrupt product supply due to\u00a0issues around the ability of the EU&#8217;s infrastructure to ensure a smooth transition when the rules came into force on May 26.\u00a0Now that the new regulatory regime has reached Wednesday&#8217;s\u00a0date of application, the trade group is once again warning that significant challenges remain unresolved that could negatively impact the sector.<\/p>\n<p>A range of MDR\u00a0<a href=\"https:\/\/www.medtechdive.com\/news\/5-questions-ahead-of-mdrs-may-26-go-live-date\/600733\/\" target=\"_blank\" rel=\"noopener\">uncertainties and potential problems<\/a>\u00a0are hovering on the horizon.\u00a0While the medical device industry has resolved some near-term pressures as the delayed landmark regulation goes into effect, MedTech Europe on Wednesday listed a litany of MDR challenges that are hindering the successful deployment of the new regulatory system.<\/p>\n<p>These MDR challenges include:<\/p>\n<ul>\n<li>Non-harmonized interpretation and application of MDR rules across the EU.<\/li>\n<li>Limited capacity among notified bodies, especially for certification of new and innovative devices.<\/li>\n<li>Uncertainties with regards to pending discussions on the rules and agreements between the EU and other countries\u00a0<a href=\"https:\/\/www.bloomberg.com\/news\/articles\/2021-05-25\/a-278-billion-brexit-like-showdown-with-eu-looms-over-the-swiss\" target=\"_blank\" rel=\"noopener\">such as Switzerland.<\/a><\/li>\n<li>Unpredictable recognition of MDR certifications at the international level vis-\u00e0-vis regulatory approvals from other jurisdictions.<\/li>\n<\/ul>\n<p>&#8220;Such challenges need ongoing attention and work by the EU Commission and Member States, if Europe is to ensure a workable system in the long-term,&#8221;\u00a0MedTech Europe said.<\/p>\n<p>The trade group also highlighted an urgent need for attention to be given to the In Vitro Diagnostic Regulation,\u00a0a major overhaul of the diagnostics sector slated to go into effect in 12 months.<\/p>\n<p>&#8220;As with the MDR, the medical technology industry fully supports the new regulatory regime for IVDs but due to many factors, the system is not yet ready to support its implementation. Urgent solutions are needed here as well, and lessons learned from the MDR implementation should be taken into account,&#8221; according to MedTech\u00a0Europe.<\/p>\n<p>The group added that it is working with the EU and stakeholders to &#8220;rapidly propose solutions to avoid disruptions&#8221; in supply of medical devices and diagnostics.<\/p>\n<hr \/>\n<\/div>\n<div class=\"editor-box\"><\/div>\n<p><br class=\"avia-permanent-lb\" \/><!-- Uberflip Embedded Hub Widget --><\/p>\n<div id=\"UfEmbeddedHub1623875919092\"><\/div>\n<p><script>\n  window._ufHubConfig = window._ufHubConfig || [];\n  window._ufHubConfig.push({\n    'containers':{'app':'#UfEmbeddedHub1623875919092'},\n    'collection': '4131730',\n    'openLink':function(url){\n      window.top.location.href=url;\n    },\n    'lazyloader':{\n      'itemDisplayLimit':20,\n      'maxTilesPerRow':0,\n      'maxItemsTotal': 3\n    },\n    'tileSize': 'small',\n    'enablePageTracking':false,\n    'baseUrl': 'https:\/\/resources.jamasoftware.com\/',\n    'filesUrl': 'https:\/\/resources.jamasoftware.com\/',\n    'generatedAtUTC': '2021-06-16 20:37:48',\n  });\n  <\/script><\/p>\n<p><script>(function(d,t,u) {\n    function load(){\n      var s=d.createElement(t);s.src=u;d.body.appendChild(s);\n    }\n    if (window.addEventListener) {\n      window.addEventListener('load',load,false);\n    }\n    else if (window.attachEvent) {\n      window.attachEvent('onload',load);\n    }\n    else{\n      window.onload=load;\n    }\n  }(document,'script','https:\/\/resources.jamasoftware.com\/hubsFront\/embed_collection'));\n  <\/script><br \/>\n<!-- \/End Uberflip Embedded Hub Widget --><\/p>\n<input class=\"fooboxshare_post_id\" type=\"hidden\" value=\"54202\"\/>","protected":false},"excerpt":{"rendered":"<p>Editor\u2019s Note:\u00a0This posts on EU MDR\u00a0was originally published\u00a0here by MedTech Drive and written by Greg Slabodkin. Dive Brief: While the Medical Device Regulation&#8217;s May 26 go-live date marks a significant milestone, MedTech Europe\u00a0warned in a statement\u00a0that MDR challenges remain, limiting the industry\u2019s ability to &#8220;seamlessly supply certified devices under the new rules.&#8221; The European trade [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":54203,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[846],"tags":[489,474,40],"industry":[574],"class_list":["post-54202","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-compliance-regulation","tag-developing-a-medical-device","tag-eu-mdr","tag-medical-device-compliance","industry-medical-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.1 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU MDR Challenges Remain as Regulation Goes Into Effect - Jama<\/title>\n<meta name=\"description\" content=\"Now that the new regulatory regime has reached application, the trade group is warning that significant MDR challenges remain unresolved.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.medtechdive.com\/news\/mdr-challenges-remain-as-regulation-goes-into-effect-medtech-europe\/600818\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR Challenges Remain as Regulation Goes Into Effect: MedTech Europe\" \/>\n<meta property=\"og:description\" content=\"Now that the new regulatory regime has reached application, the trade group is warning that significant MDR challenges remain unresolved.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.medtechdive.com\/news\/mdr-challenges-remain-as-regulation-goes-into-effect-medtech-europe\/600818\/\" \/>\n<meta property=\"og:site_name\" content=\"Jama Software\" \/>\n<meta property=\"article:published_time\" content=\"2021-06-23T10:00:26+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-01-13T00:49:03+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.jamasoftware.com\/legacy\/media\/2021\/06\/2021-06-23_MDR-MedTech-Post-1024x512-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Jama Software\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jama Software\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.medtechdive.com\\\/news\\\/mdr-challenges-remain-as-regulation-goes-into-effect-medtech-europe\\\/600818\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2021\\\/06\\\/23\\\/mdr-challenges-remain-as-regulation-goes-into-effect-medtech-europe\\\/\"},\"author\":{\"name\":\"Jama Software\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/#\\\/schema\\\/person\\\/59a942565a528aa5f56b240c9342fc7f\"},\"headline\":\"MDR Challenges Remain as Regulation Goes Into Effect: MedTech Europe\",\"datePublished\":\"2021-06-23T10:00:26+00:00\",\"dateModified\":\"2023-01-13T00:49:03+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2021\\\/06\\\/23\\\/mdr-challenges-remain-as-regulation-goes-into-effect-medtech-europe\\\/\"},\"wordCount\":479,\"image\":{\"@id\":\"https:\\\/\\\/www.medtechdive.com\\\/news\\\/mdr-challenges-remain-as-regulation-goes-into-effect-medtech-europe\\\/600818\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.jamasoftware.com\\\/media\\\/2021\\\/06\\\/2021-06-23_MDR-MedTech-Post-1024x512-1.jpg\",\"keywords\":[\"developing a medical device\",\"EU MDR\",\"Medical Device Compliance\"],\"articleSection\":[\"Compliance &amp; Regulation\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2021\\\/06\\\/23\\\/mdr-challenges-remain-as-regulation-goes-into-effect-medtech-europe\\\/\",\"url\":\"https:\\\/\\\/www.medtechdive.com\\\/news\\\/mdr-challenges-remain-as-regulation-goes-into-effect-medtech-europe\\\/600818\\\/\",\"name\":\"EU MDR Challenges Remain as Regulation Goes Into Effect - 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