{"id":24608,"date":"2022-11-22T09:46:29","date_gmt":"2022-11-22T08:46:29","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=24608"},"modified":"2022-11-22T14:26:45","modified_gmt":"2022-11-22T13:26:45","slug":"italy-ministry-of-health-issues-document-on-surveillance-requirements","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/11\/22\/italy-ministry-of-health-issues-document-on-surveillance-requirements\/","title":{"rendered":"ITALY: Ministry of Health issues document on surveillance requirements"},"content":{"rendered":"<h2>Last 11<sup>th<\/sup> October, the Italian Ministry of Health issued the document <a href=\"https:\/\/www.trovanorme.salute.gov.it\/norme\/renderNormsanPdf?anno=2022&amp;codLeg=89644&amp;parte=1%20&amp;serie=null\">\u201cVigilanza sugli incidenti con i dispositivi medici\u201d<\/a> which provides specifics about the <strong>operational instructions on modalities and timing<\/strong> of Medical Devices\u2019 Manufacturers\u2019 reports, addressed to Economic Operators involved in <strong>serious and non-serious accidents as well as complaints<\/strong> after such Medical Devices have been placed on the market, in particular in relation to Article 10 of <a href=\"https:\/\/www.gazzettaufficiale.it\/eli\/id\/2022\/09\/13\/22G00145\/sg\"><strong>Legislative Decree 5<sup>th<\/sup> August 2022, No.137<\/strong><\/a>, in force since 28 September last.<\/h2>\n<p>In particular, in the event of an <strong>accident<\/strong>, the Manufacturer is obliged to:<\/p>\n<ul>\n<li>Acquire all necessary information relating to the accident;<\/li>\n<li>Report the accident to the competent Authority using the <em>Manufacturer Incident Report<\/em> form MIR 7.2.1:<\/li>\n<li>Within <strong>15 days<\/strong> in case of serious accidents;<\/li>\n<li>Within <strong>2 days<\/strong> in case of a serious threat to public health;<\/li>\n<li>Within <strong>10 days<\/strong> in case of death or unexpected serious deterioration of a person&#8217;s health;<\/li>\n<\/ul>\n<p>NB: the Manufacturer may also submit Periodic Summary Reports (PSRs) instead of individual reports in the case of similar serious accidents occurring with the <strong>same device or same device type<\/strong> and for which the root cause has been identified; in this case the <em>Manufacturer&#8217;s Periodic Summary Report<\/em> template contained in Meddev 2.12-1 Rev.8 should be used.<\/p>\n<p>In the case of non-serious accidents or <strong>unexpected undesirable side effects<\/strong>, the Manufacturer is required to report any significant increase in the frequency or severity of the accident by means of <strong>Trend reports<\/strong>, to be sent to the competent Authorities.<\/p>\n<ul>\n<li>Take corrective safety action: <strong>corrective safety action<\/strong> must be reported in Italian without undue delay through the <em>Field Safety Corrective Action (FSCA)<\/em> and the <em>Field Safety Notice (FSN)<\/em>, before such corrective safety action is taken.<\/li>\n<\/ul>\n<p><strong>Public and private Healthcare Professionals<\/strong> who detect a serious or non-serious accident involving a Medical Device are required to report it to the Ministry of Health, to the Manufacturer or to its Authorised Representative also through the Distributor. In the case of a <strong>serious accident<\/strong>, the Healthcare Professional is required to report it <strong>as a matter of urgency and no later than 10 days<\/strong>; in the case of a <strong>non-serious accident<\/strong>, it is advisable to report it <strong>within 30 days<\/strong>. In the event of a <strong>complaint<\/strong>, the Healthcare Professional is required to make a report to the Manufacturer, also through the Distributor, and at the same time, to the Ministry of Health.<\/p>\n<p>Finally, the device that is the subject of the accident must be returned to the Manufacturer 10 days after becoming aware of such accident.<\/p>\n<p>The above indications may be subject to revision and modification: we will keep you informed in case of further developments or updates.<\/p>\n<h3>&gt;&gt; Do you need help implementing the requirements for post-market surveillance as defined by MDR (EU) 2017\/745 and national supplementary measures?<\/h3>\n<p>Rely on Thema\u2019s experts for <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\"><strong>strategic-regulatory consulting<\/strong><\/a> and <a href=\"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\"><strong>CE certification support<\/strong><\/a>.<\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/contact-us-2\/\"><strong>Contact us<\/strong><\/a> for more info!<\/p>\n<p>Source: <a href=\"https:\/\/www.trovanorme.salute.gov.it\/norme\/renderNormsanPdf?anno=2022&amp;codLeg=89644&amp;parte=1%20&amp;serie=null\">https:\/\/www.trovanorme.salute.gov.it\/norme\/renderNormsanPdf?anno=2022&amp;codLeg=89644&amp;parte=1%20&amp;serie=null<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Last 11th October, the Italian Ministry of Health issued the document \u201cVigilanza sugli incidenti con i dispositivi medici\u201d which provides specifics  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":24591,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-24608","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ITALY: Ministry of Health issues document on surveillance requirements<\/title>\n<meta name=\"description\" content=\"The Italian Ministry of Health issued the document \u201cVigilanza sugli incidenti con i dispositivi medici\u201d which provides specifics about...\" \/>\n<meta name=\"robots\" content=\"index, follow, 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