{"id":76217,"date":"2016-11-17T13:42:33","date_gmt":"2016-11-17T13:42:33","guid":{"rendered":"http:\/\/mostafa.openonline.co.uk\/?guid=6e270380e786c3a4c409a64d17ca2cba"},"modified":"2016-11-17T13:42:33","modified_gmt":"2016-11-17T13:42:33","slug":"news-story-mhra-leading-european-action-to-reinforce-market-surveillance-of-medical-devices-to-protect-public-health","status":"publish","type":"post","link":"https:\/\/mostafa.openonline.co.uk\/?p=76217","title":{"rendered":"News story: MHRA leading European action to reinforce market surveillance of medical devices to protect public health"},"content":{"rendered":"<div class=\"govspeak\">\n<p>Medical devices cover a wide range of products \u2013 from sticking plasters to hip replacements, from contact lenses to personal oxygen tanks and implanted pacemakers. These devices and others like them, can be found in every household across Europe, once they have been CE marked.<\/p>\n<p>To make sure devices like these are acceptably safe and perform as intended, Competent Authorities need to have a strong programme of market surveillance.<\/p>\n<p>On 19 October 2016, at the 39th meeting of the Competent Authorities for Medical Devices in Bratislava, Slovakia, <abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> officially launched the Joint Action on Market Surveillance of Medical Devices.<\/p>\n<p>The project aims to reinforce the market surveillance system for medical devices by improving the coordination of activities by all member states of the European Union, and ensuring adequate communications and cooperation. These are crucial for success and effectiveness of the market surveillance in the field of medical devices.<\/p>\n<p>The Joint Action supports the Consumers, Health, Agriculture and Food Executive Agency\u2019s (Chafea) programme of community action in the field of health to deliver against one of its objectives: to contribute to innovative, efficient and sustainable health systems.<\/p>\n<p>Chafea is entrusted by the European Commission to implement the <a rel=\"external\" href=\"http:\/\/ec.europa.eu\/health\/programme\/policy\/index_en.htm\">health programme<\/a> and EU Members States involved in the programme \u2013 in January 2016.<\/p>\n<p>John Wilkinson, <abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr>\u2019s Director of Medical Devices, said:<\/p>\n<blockquote>\n<p class=\"last-child\">We are pleased to be leading this important activity and look forward to working with our colleagues across the EU in delivering improvements to reinforce market surveillance.<\/p>\n<\/blockquote>\n<h2 id=\"background\">Background<\/h2>\n<ol>\n<li>\n<p>The Joint Action will be implemented through five work packages: <abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> leads on three (Coordination dissemination and evaluation), while two will be implemented and delivered by EU Member State partners: the Netherlands (manufacturers\u2019 inspection) and Ireland (clinical process and resource development).<br \/>\nMore information about the Joint Action can be found on the <a rel=\"external\" href=\"http:\/\/www.camd-europe.eu\/\">CAMD website<\/a><\/p>\n<\/li>\n<li>\n<p>To report a suspected problem or incident with a medical device please visit the <a rel=\"external\" href=\"https:\/\/yellowcard.mhra.gov.uk\/\">Yellow Card Scheme<\/a> website.<\/p>\n<\/li>\n<li>\n<p><abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. <abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency  is an executive agency of the Department of Health. <a href=\"https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency\">www.mhra.gov.uk<\/a><\/p>\n<\/li>\n<\/ol>\n<div class=\"contact postal-address\" id=\"contact_2345\">\n<div class=\"content\">\n<h3>Media enquiries<\/h3>\n<div class=\"vcard contact-inner\">\n<p class=\"adr\">\n<span class=\"fn\">News centre<\/span><br \/>\n<span class=\"street-address\"><abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr><br \/>\n<br \/>\n151 Buckingham Palace Road<br \/>\n<br \/>\nVictoria<\/span><br \/>\n<span class=\"locality\">London<\/span><br \/>\n<span class=\"postal-code\">SW1W 9SZ<\/span>\n<\/p>\n<div class=\"email-url-number\">\n<p class=\"email\">\n              <span class=\"type\">Email<\/span><br \/>\n              <a class=\"email\" href=\"mailto:newscentre@mhra.gsi.gov.uk\">newscentre@mhra.gsi.gov.uk<\/a>\n            <\/p>\n<p class=\"tel\">\n              <span class=\"type\">During office hours:<\/span><br \/>\n              020 3080 7651 (08:30 &#8211; 17:00)\n            <\/p>\n<p class=\"tel\">\n              <span class=\"type\">Out of office hours:<\/span><br \/>\n              07770 446 189 (17:00 &#8211; 08:30)\n            <\/p>\n<\/p><\/div>\n<p class=\"comments\">Office hours are Monday to Friday, 8:30am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at <a href=\"https:\/\/www.twitter.com\/mhrapress\">https:\/\/www.twitter.com\/mhrapress<\/a><\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The Medicines and Healthcare products Regulatory Agency (MHRA) has officially launched the Joint Action on Market Surveillance of Medical Devices.<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"_links":{"self":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/76217"}],"collection":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=76217"}],"version-history":[{"count":0,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/76217\/revisions"}],"wp:attachment":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=76217"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=76217"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=76217"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}