{"id":2450,"date":"2012-03-31T05:36:13","date_gmt":"2012-03-31T05:36:13","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=2450"},"modified":"2012-03-31T05:36:13","modified_gmt":"2012-03-31T05:36:13","slug":"electronic-ifus-for-eu-mdd-aimdd-devices","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2012\/03\/31\/electronic-ifus-for-eu-mdd-aimdd-devices\/","title":{"rendered":"Electronic IFUs for EU MDD &#038; AIMDD Devices"},"content":{"rendered":"<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther:<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The <a title=\"EU Commission Regulation of Electronic IFUs of Medical Devices\" href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2012\/03\/Electronic-IFUs-of-Med-Dvcs-Commission-Regulation-EU-No-2072012-of-9MAR2012.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Commission Regulation of electronic instructions for use (IFUs) of Medical Devices 207\/2012<\/a>\u00a0was released 10 March 2012. \u00a0Here\u2019s a general summary:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The directive does not cover IVDD devices which have their own guidance document.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">In general, an e-IFU is allowed for:<\/span><\/li>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">AIMDD and MDD devices intended exclusively for professional use where use by other persons is not reasonably foreseeable.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">MDD device fitted with a built-in system visually displaying the instructions for use.<\/span><\/li>\n<\/ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">It is important to read the full requirements.\u00a0 Below is a summary of some key items.<\/span><\/li>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">A documented risk analysis is required covering at least the items listed in Article 4 of the e-IFU directive (intended users\u2019 access to hardware and software to view the e-IFU, intended use environment and access to e-IFU at time of use, etc.).\u00a0 BSI provided a link,<a href=\"http:\/\/www.abhi.org.uk\/multimedia\/120215_risk_analysis-user_profiling_survey.pdf?utm_source=BSI+eUpdate+EU+Regulation+on+e-Labeling+of+Medical+Devices+Has+Arrived&amp;utm_medium=et_mail&amp;utm_content=2015238&amp;utm_campaign=BSI+eUpdate+EU+Regulation+on+e-Labeling+of+Medical+Devices+Has+Arrived_30_March_2012&amp;utm_term=Participate+Here\" target=\"_blank\" rel=\"noopener noreferrer\"> <strong>e-IFU REGULATION RISK ASSESSMENT SURVEY<\/strong><\/a>, to a general survey which may help avoid the need to run individual surveys.\u00a0 As with all risk analyses, it must be updated based on experience from the post-marketing phase.<\/span><\/span><!--more--><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device must be provided with the device.\u00a0 The information may be on the device or on a leaflet sent with the device.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Instructions must remain available:<\/span><\/li>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">For 2 years after the expiry date of the last produced device.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">For 15 years after the last device has been manufactured for:<\/span><\/li>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Devices without an expiry date.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Implantable devices.<\/span><\/li>\n<\/ul>\n<\/ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">There are specific requirements when the e-IFU is available through a website such as server downtime and display errors must be reduced as far as possible, and access must meet<a href=\"http:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=CONSLEG:1995L0046:20031120:EN:PDF\" target=\"_blank\" rel=\"noopener noreferrer\"> directive 95\/46\/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data<\/a>.\u00a0<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Hardcopy of the IFU must be provided no later than 7 days from request and at no charge to the user.<\/span><\/li>\n<\/ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">As of March 2013, the Notified Body will need to review compliance (with the exception of Class I MDD devices).<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Additional requirements may apply<\/strong> to specific devices based on relevant standards.\u00a0 For example, from EN 60601-1:2006 (same as IEC 60601-1:2005):<\/span><\/p>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">For medical devices, clause 7.9.1 states, \u201cACCOMPANYING DOCUMENTS may be provided electronically, e.g. electronic file format on CDROM.\u00a0 If the ACCOMPANYING DOCUMENTS are provided electronically, the RISK MANAGEMENT PROCESS shall include consideration of which information also needs to be provided as hard copy or as markings on the ME EQUIPMENT, e.g. to cover emergency operation.\u201d<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">For medical systems, clause 16.2 states, \u201cNOTE ACCOMPANYING DOCUMENTS can be provided electronically, e.g. electronic file format or CD-ROM, for an ME SYSTEM capable of displaying or printing those documents.\u201d<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The Commission Regulation of electronic instructions for use (IFUs) of Medical Devices 207\/2012\u00a0was released 10 March 2012. \u00a0Here\u2019s a general summary: The directive does not cover<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[26,61,15,16,262,35,353,549,550,551,232,552,355,63,64,185,10,371,358,4,553,12,28,22,330,266,174,175,149,32,554,422,555,5],"class_list":["post-2450","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-200747ec","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-active-implantable-medical-devices-directive","tag-aimdd","tag-dfu","tag-directions-for-use","tag-e-dfu","tag-e-ifu","tag-ec","tag-electronic-instructions","tag-electronic-instructions-for-use","tag-en60601","tag-en60601-1","tag-eu","tag-fda-guidance","tag-guidance-document","tag-ifu","tag-iso-14971","tag-leaflet","tag-mdd","tag-mdd-amendment","tag-medical","tag-medical-device","tag-medical-device-directive","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-notified-body","tag-personal-data","tag-risk-analysis","tag-risk-assessment","tag-risk-management"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2450","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=2450"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2450\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=2450"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=2450"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=2450"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}