{"id":248978,"date":"2021-06-01T12:45:49","date_gmt":"2021-06-01T07:15:49","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=248978"},"modified":"2021-12-30T11:35:30","modified_gmt":"2021-12-30T06:05:30","slug":"eu-medical-devices-regulation-mdr-comes-into-force","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2021\/06\/01\/eu-medical-devices-regulation-mdr-comes-into-force\/","title":{"rendered":"EU Medical Devices Regulation (MDR) comes into force"},"content":{"rendered":"<p style=\"text-align: justify;\">On May 26, 2021 the EU Medical Devices Regulation (MDR) entered into effect after a four-year transitional period. The Regulation introduces various changes which will have an effect on the supply chain for medical devices.<\/p>\n<p>&nbsp;<\/p>\n<blockquote>\n<p style=\"text-align: justify;\"><span style=\"color: #008000;\">Mr. Murali Neelakantan says that &#8220;MDR requires Pharma companies to display unique device identification (UDI) numbers used to track devices and instructions for use (IFU).<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #008000;\">This Regulation will alter the operations of medical device manufacturers and even impact the composition of their existing as well as future portfolios. Cost of compliance will most likely be significant. It is critical that businesses take action now to implement organisational changes.&#8221;<\/span><\/p>\n<\/blockquote>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><span dir=\"ltr\">Article 2 of <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32017R0745\">Regulation (EU) 2017\/745<\/a> defines &#8216;Medical <\/span><span dir=\"ltr\">device\u2019 as<\/span> <span dir=\"ltr\">any instrument, <\/span><span dir=\"ltr\">apparatus, <\/span><span dir=\"ltr\">appliance, <\/span><span dir=\"ltr\">software, <\/span><span dir=\"ltr\">implant, <\/span><span dir=\"ltr\">reagent, <\/span><span dir=\"ltr\">material or other article <\/span><span dir=\"ltr\">intended by the manufacturer <\/span><span dir=\"ltr\">to be used, alone or in combination, <\/span><span dir=\"ltr\">for human <\/span><span dir=\"ltr\">beings <\/span><span dir=\"ltr\">for one or more of the <\/span><span dir=\"ltr\">following specific <\/span><span dir=\"ltr\">medical <\/span><span dir=\"ltr\">purposes: <\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span dir=\"ltr\">diagnosis, <\/span><span dir=\"ltr\">prevention, <\/span><span dir=\"ltr\">mo<\/span><span dir=\"ltr\">nitori<\/span><span dir=\"ltr\">ng, prediction, <\/span><span dir=\"ltr\">prognosis, <\/span><span dir=\"ltr\">treatment <\/span><span dir=\"ltr\">or alleviation <\/span><span dir=\"ltr\">of disease,\u00a0<\/span><\/li>\n<li><span dir=\"ltr\"> diagnosis, <\/span><span dir=\"ltr\">monitori<\/span><span dir=\"ltr\">ng, treatment, <\/span><span dir=\"ltr\">alleviation <\/span><span dir=\"ltr\">of, or compen<\/span><span dir=\"ltr\">sation for, an injury or disability<\/span><span dir=\"ltr\">,\u00a0<\/span><\/li>\n<li><span dir=\"ltr\"> investig<\/span><span dir=\"ltr\">ation, <\/span><span dir=\"ltr\">replacement <\/span><span dir=\"ltr\">or modification <\/span><span dir=\"ltr\">of the anatomy or of a physiological <\/span><span dir=\"ltr\">or pathological <\/span><span dir=\"ltr\">process <\/span><span dir=\"ltr\">or <\/span><span dir=\"ltr\">state, <\/span><\/li>\n<li><span dir=\"ltr\">providing <\/span><span dir=\"ltr\">information <\/span><span dir=\"ltr\">by means <\/span><span dir=\"ltr\">of <\/span><span dir=\"ltr\">in vitro <\/span><span dir=\"ltr\">examination <\/span><span dir=\"ltr\">of specimens <\/span><span dir=\"ltr\">derived from the human <\/span><span dir=\"ltr\">body, including <\/span><span dir=\"ltr\">organ, <\/span><span dir=\"ltr\">blood and tissue donations, <\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span dir=\"ltr\">and which does not achieve its principal <\/span><span dir=\"ltr\">intended <\/span><span dir=\"ltr\">action <\/span><span dir=\"ltr\">by pharmacological, <\/span><span dir=\"ltr\">immunological <\/span><span dir=\"ltr\">or metabolic <\/span><span dir=\"ltr\">means, <\/span><span dir=\"ltr\">in or on the human <\/span><span dir=\"ltr\">body, but which <\/span><span dir=\"ltr\">may be assisted <\/span><span dir=\"ltr\">in its function <\/span><span dir=\"ltr\">by such means. <\/span><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><span dir=\"ltr\">The following products <\/span><span dir=\"ltr\">shall also be deemed <\/span><span dir=\"ltr\">to be medical <\/span><span dir=\"ltr\">devices: <\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span dir=\"ltr\">devices <\/span><span dir=\"ltr\">for the control <\/span><span dir=\"ltr\">or suppor<\/span><span dir=\"ltr\">t of concept<\/span><span dir=\"ltr\">ion; <\/span><\/li>\n<li><span dir=\"ltr\">products <\/span><span dir=\"ltr\">specifically intended <\/span><span dir=\"ltr\">for the cleaning, <\/span><span dir=\"ltr\">disinfection <\/span><span dir=\"ltr\">or sterilisation <\/span><span dir=\"ltr\">of devices <\/span><span dir=\"ltr\">as referred to in <\/span><span dir=\"ltr\">Article 1(4) and of those referred to in the first paragraph <\/span><span dir=\"ltr\">of this point.<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\">The new EU MDR regulation aims to create a new and improved landscape for the medical devices industry, with the following guidelines:<\/p>\n<ol style=\"text-align: justify;\">\n<li>All medical devices will have to undergo an independent assessment of safety and performance before they can be marketed in the EU.<\/li>\n<li>There will be greater transparency of information on the benefits for patients, residual risks, and a thorough assessment of the overall risk\/benefit ratio will be necessary.<\/li>\n<li>There will be clearer rules in place to enable standardisation and support simpler and less complex trading between EU member states.<\/li>\n<li>The new rules support patient-oriented innovation and take particular account of the specific needs of the many small and medium sized manufacturers in this sector.<\/li>\n<li>The EU MDR will place further responsibilities on \u201cNotified Bodies\u201d &#8211; those independent third parties that perform conformity assessments for medium and high risk devices. The Notified Bodies will be subject to heightened scrutiny from competent authorities and will need to be designated under the EU MDR, with the process of designation coordinated at a European level.<\/li>\n<li>Non-compliance of the Regulation will impose penalty.<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\">In order to put a required system in place for risk and quality management and to conduct clinical or performance evaluations, the Regulation clarifies the respective obligations of manufacturers, authorised representatives, importers and distributors.<\/p>\n<p style=\"text-align: justify;\"><span dir=\"ltr\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On May 26, 2021 the EU Medical Devices Regulation (MDR) entered into effect after a four-year transitional period. The Regulation introduces various <\/p>\n","protected":false},"author":8808,"featured_media":249078,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[14,4],"tags":[],"class_list":["post-248978","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-foreign","category-legislationupdates"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU Medical Devices Regulation (MDR) comes into force | SCC Times<\/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:\/\/www.scconline.com\/blog\/post\/2021\/06\/01\/eu-medical-devices-regulation-mdr-comes-into-force\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU Medical Devices Regulation (MDR) comes into force\" \/>\n<meta property=\"og:description\" content=\"On May 26, 2021 the EU Medical Devices Regulation (MDR) entered into effect after a four-year transitional period. 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