{"id":3257,"date":"2013-04-27T05:12:12","date_gmt":"2013-04-27T05:12:12","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3257"},"modified":"2013-04-27T05:12:12","modified_gmt":"2013-04-27T05:12:12","slug":"meddev-2-12-1-guidelines-on-medical-devices-vigilance-system-updated-to-rev-8","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2013\/04\/27\/meddev-2-12-1-guidelines-on-medical-devices-vigilance-system-updated-to-rev-8\/","title":{"rendered":"MEDDEV 2.12-1 Guidelines on Medical Devices Vigilance System Updated to Rev 8"},"content":{"rendered":"<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">This blog post is thx to our associate Christine Ruther and a special thx goes out to\u00a0Helene Spencer.<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">MEDDEV 2.12-1 <em>Guidelines on a Medical Devices Vigilance System<\/em> was updated in January 2013.\u00a0 The revised guidance is <span style=\"color: #ff0000;\">applicable as of July 2013<\/span>.\u00a0 \u00a0The revision contains clarifications rather than significant changes.<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\"><!--more-->Download the <strong><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2013\/04\/MEDDEV-2.12-1-rev-8-Med-Dvc-Vigilance-System-JAn-2013-effecttive-July-2013.pdf\">MEDDEV 2.12\/1 revision 8 <em>Guidelines on a Medical Device Vigilance System<\/em> effective July 2013<\/a><\/strong>.\u00a0 An unofficial\u00a0<strong><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2013\/04\/Comparison-of-MEDDEV-2.121-from-rev7-to-rev-8-Vigilance-UNOFFICIAL.pdf\">Comparison of MEDDEV 2.12\/1 from revision 7 to revision 8<\/a><\/strong>\u00a0can be downloaded, as well.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\"><strong><span style=\"text-decoration: underline;\">Changes include:<\/span><\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Clarification that, in addition to IVD\u2019s, indirect harm can be from:<\/span>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">diagnostic devices,<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">consequence of the treatment of cells (e.g. gametes and embryos in the case of IVF\/ART devices) or organs outside of the human body that will later be transferred to a patient, or<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">software qualified as medical devices (e.g., incorrect information generated by software).<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Reinforcement that, when there is doubt, a report should be submitted.<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Clarification that, regardless of how a lack of performance to labeled specifications is identified (field report, in-house testing, etc.), if the issue might lead to or might have led to death or serious deterioration in the state of health associated with the use of the device and the issue impacts a product that has already been placed on the market then a field safety correct action (FSCA) must be initiated.<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Adds \u201cabsence of treatment\u201d as an indirect harm that must be considered.<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Indicates that a National Competent Authority should consult the manufacturer or the manufacturer\u2019s European Representative before forwarding a National Competent Authority Report (NCAR) to fellow National Competent Authorities.<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Updates to reporting formats from the MEDDEV website are below in the formats that they provide them in:<\/span><\/li>\n<\/ul>\n<p style=\"padding-left: 150px;\"><a href=\"http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/2_12_1-mir_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><strong style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Manufacturer Incident Report<\/strong><span style=\"font-family: arial, helvetica, sans-serif; font-size: x-small;\"><img decoding=\"async\" src=\"http:\/\/ec.europa.eu\/wel\/images\/doc_icons\/f_pdf_16.gif\" alt=\"pdf\" \/><\/span><\/a><span style=\"font-family: arial, helvetica, sans-serif; font-size: x-small;\">(971 KB)<\/span><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">\u00a0<\/span><br style=\"font-family: arial, helvetica, sans-serif; font-size: small;\" \/><a href=\"http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/mir_use_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><strong style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">How to use the MIR<\/strong><span style=\"font-family: arial, helvetica, sans-serif; font-size: x-small;\"><img decoding=\"async\" src=\"http:\/\/ec.europa.eu\/wel\/images\/doc_icons\/f_pdf_16.gif\" alt=\"pdf\" \/><\/span><\/a><span style=\"font-family: arial, helvetica, sans-serif; font-size: x-small;\">(13 KB)<\/span><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">\u00a0<\/span><br style=\"font-family: arial, helvetica, sans-serif; font-size: small;\" \/><a href=\"http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/2_12_1-fsca_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><strong style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Field Safety Corrective Action<\/strong><span style=\"font-family: arial, helvetica, sans-serif; font-size: x-small;\"><img decoding=\"async\" src=\"http:\/\/ec.europa.eu\/wel\/images\/doc_icons\/f_pdf_16.gif\" alt=\"pdf\" \/><\/span><\/a><span style=\"font-family: arial, helvetica, sans-serif; font-size: x-small;\">(2 MB)<\/span><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">\u00a0<\/span><br style=\"font-family: arial, helvetica, sans-serif; font-size: small;\" \/><a href=\"http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/form_2_12_1_rev7_trend_en.doc\" target=\"_blank\" rel=\"noopener noreferrer\"><strong style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Trend Report<\/strong><span style=\"font-family: arial, helvetica, sans-serif; font-size: x-small;\"><img decoding=\"async\" src=\"http:\/\/ec.europa.eu\/wel\/images\/doc_icons\/f_msw8_16.gif\" alt=\"msw8\" \/><\/span><\/a><span style=\"font-family: arial, helvetica, sans-serif; font-size: x-small;\">(151 KB)<\/span><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">\u00a0<\/span><br style=\"font-family: arial, helvetica, sans-serif; font-size: small;\" \/><a href=\"http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/form_2_12_1_rev7_psr_en.doc\" target=\"_blank\" rel=\"noopener noreferrer\"><strong style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Periodic Summary Report<\/strong><span style=\"font-family: arial, helvetica, sans-serif; font-size: x-small;\"><img decoding=\"async\" src=\"http:\/\/ec.europa.eu\/wel\/images\/doc_icons\/f_msw8_16.gif\" alt=\"msw8\" \/><\/span><\/a><span style=\"font-family: arial, helvetica, sans-serif; font-size: x-small;\">(192 KB)<\/span><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">\u00a0<\/span><br style=\"font-family: arial, helvetica, sans-serif; font-size: small;\" \/><a href=\"http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/mir_and_fsca_xml.zip\" target=\"_blank\" rel=\"noopener noreferrer\"><strong style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">MIR and FSCA xml files<\/strong><span style=\"font-family: arial, helvetica, sans-serif; font-size: x-small;\"><img decoding=\"async\" src=\"http:\/\/ec.europa.eu\/wel\/images\/doc_icons\/f_zip_16.gif\" alt=\"zip\" \/><\/span><\/a><span style=\"font-family: arial, helvetica, sans-serif; font-size: x-small;\">(2 MB)<\/span><strong style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">\u00a0<strong>\u00a0<\/strong><\/strong><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\"><strong><span style=\"text-decoration: underline;\">Actions to consider:<\/span><\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Review your MEDDEV procedure(s) to ensure that:<\/span>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Any source of indirect harm will be considered and, if such could result in harm, will result in submission of an incident report.<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Actions taken to reduce risk of death or serious deterioration in the state of health associated with the use of a device that is already placed on the market will be reported through a Field Safety Corrective Action Report.<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">\u201cAbsence of treatment\u201d is an indirect harm that will be considered when making a reporting decision.<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Where there is doubt, a report will be submitted.<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Referenced forms reflect the current versions and requirements for completion.<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Review the contract with your European Representative to ensure that it is clear on how the company expects the EU Rep to respond to a request for comment on a NCAR.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Many thanks to Helene Spencer to highlighting the new revision (and for indicating that, with a little work, it is possible to create an unofficial redline).<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">If you need assistance with this or other issues, please contact us at Leo@EisnerSafety.com.\u00a0 As a reminder, you can access a <strong><a href=\"http:\/\/ec.europa.eu\/health\/medical-devices\/documents\/guidelines\/index_en.htm\" target=\"_blank\" rel=\"noopener noreferrer\">full list of MEDDEV\u2019s<\/a><\/strong> from the MEDDEV guidance website\u00a0.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>This blog post is thx to our associate Christine Ruther and a special thx goes out to\u00a0Helene Spencer. MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System was updated in January 2013.\u00a0 The revised guidance is applicable as of July<\/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":[262,500,27,185,412,556,194,557,20,12,28,44,963,964,22,266,174,175,149,433,32,965,966,5,558,559,34,560],"class_list":["post-3257","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-active-implantable-medical-devices-directive","tag-competent-authority","tag-escnews","tag-eu","tag-european-medical-device","tag-field-safety","tag-guidance-documents","tag-incident-report-form","tag-ivd","tag-mdd","tag-mdd-amendment","tag-meddev","tag-meddev-2-121","tag-meddev2-12-1","tag-medical","tag-medical-device-directive","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-notified-bodies","tag-notified-body","tag-revision-7","tag-revision-8","tag-risk-management","tag-trend-report","tag-trend-reports","tag-vigilance","tag-vigilance-system"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3257","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=3257"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3257\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3257"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3257"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3257"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}