{"id":2857,"date":"2012-11-13T06:20:40","date_gmt":"2012-11-13T06:20:40","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=2857"},"modified":"2012-11-13T06:20:40","modified_gmt":"2012-11-13T06:20:40","slug":"eu-team-nb-issues-a-code-of-conduct-some-have-signed","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2012\/11\/13\/eu-team-nb-issues-a-code-of-conduct-some-have-signed\/","title":{"rendered":"EU Team-NB adopted V3.0 Code of Conduct &#8211; Align to Recent Proposed Regulations"},"content":{"rendered":"<p><span style=\"font-family: arial, helvetica, sans-serif;\">On 10 Oct 2012 <strong><a href=\"http:\/\/www.team-nb.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">The European Association for Medical devices of Notified Bodies<\/a><\/strong> (better known as <strong><a href=\"http:\/\/www.team-nb.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">Team-NB<\/a><\/strong>) issued a <strong><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2012\/11\/Team-NB-Press-release-COC1.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">press release on the adoption of Version 3.0 of the Code of Conduct (CoC) for Notified Bodies<\/a><\/strong> under Directives 90\/385\/EEC (Active Implantable Medical Devices Directive), 93\/42\/EEC (Medical Devices Directive), and 98\/79\/EC (In-Vitro Diagnostic Directive) that is focusing on the <strong><a title=\"White Paper on Propposed New EU Medical Device Regulations\" href=\"http:\/\/www.eisnersafety.com\/white-paper-on-proposed-new-eu-medical-device-regulations\/\" target=\"_blank\" rel=\"noopener noreferrer\">recently proposed Medical Device Regulations<\/a><\/strong>. \u00a0<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif;\"><!--more--><\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif;\">Team-NB is a voluntary organization of Medical Device Notified Bodies (doesn&#8217;t represent all EU NB&#8217;s under the 3 Medical Device Directives) and as of 12 Nov 2012 there are now 35 members. \u00a0During the 9 Oct 2012 Assembly in addition to the adoption of the CoC three (3) new members were unanimously added (LGA InterCert GmbH &#8211; Nurnberg Deutschland,\u00a0UDEM &#8211;\u00a0Ankara Turkey, and\u00a0ALBERK QA TECKNIC &#8211;\u00a0Istanbul Turkey).<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif;\">The <strong><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2012\/11\/Code_of_Conduct_Medical_Notified_Bodies_v3-0.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Version 3.0 Code of Conduct for Notified Bodies under Directives 90\/385\/EEC, 93\/42\/EEC, &amp; 98\/79\/EC<\/a><\/strong> is a very thorough document which is 31 pages long and includes the Unannounced Inspections (or Unannounced Audits of Medical Device Manufacturers that are Certified under the applicable Medical Directive) which comes from the\u00a0<strong><a title=\"White Paper on Propposed New EU Medical Device Regulations\" href=\"http:\/\/www.eisnersafety.com\/white-paper-on-proposed-new-eu-medical-device-regulations\/\" target=\"_blank\" rel=\"noopener noreferrer\">recently proposed Medical Device Regulations<\/a><\/strong>. \u00a0As of the <strong><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2012\/11\/TEAM-NB-Member-List-COC-signed-by-14-NBs-201210301.doc\" target=\"_blank\" rel=\"noopener noreferrer\">30 October 2012 News Release 14 Notified Bodies had signed the V3.0 CoC<\/a><\/strong>\u00a0and 2 additional NBs (LNE\/G-MED &amp; DQS) signed prior to 12 Nov 2012. \u00a0It is anticipated that more NBs will sign in the near future as they adopt the policies covered within the V3.0 CoC which shows their commitment to improve the implementation of the EU CE marking certification of medical devices through clarified organizational criteria, management of competence and assessment practices. \u00a0The major topics in the document are:<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif;\">Implementation, enforcement and monitoring of the Code of Conduct <\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif;\">Qualification and Assignment of Notified Body Assessment Personnel <\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif;\">Minimum time for Notified Body assessments <\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif;\">Unannounced visits <\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif;\">Sampling of class IIa and IIb technical files <\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif;\">Design Dossier Reviews <\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif;\">Rules for subcontracting <\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif;\">Rules for Certification Decisions\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial, helvetica, sans-serif;\">Further revisions will be made to be in line with the new developments of the European legislation.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 10 Oct 2012 The European Association for Medical devices of Notified Bodies (better known as Team-NB) issued a press release on the adoption of Version 3.0 of the Code of Conduct (CoC) for Notified Bodies under Directives 90\/385\/EEC (Active<\/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":[26,258,259,260,262,35,36,365,286,735,736,185,659,737,579,244,206,738,20,739,265,12,28,266,417,174,604,372,175,149,513,740,741,32,5,742,743,744,745,427,746,747,748],"class_list":["post-2857","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-200747ec","tag-90385eec","tag-9342eec","tag-9879ec","tag-active-implantable-medical-devices-directive","tag-aimdd","tag-cenelec","tag-class-i","tag-class-iii","tag-code-of-conduct-for-notified-bodies","tag-design-dossier-reviews","tag-eu","tag-eu-active-implantable-medical-device-directive","tag-eu-medical-device-regulation","tag-eu-notified-bodies","tag-eu-notified-body","tag-european-commission","tag-implantable-medical-devices","tag-ivd","tag-ivd-directive","tag-ivdd","tag-mdd","tag-mdd-amendment","tag-medical-device-directive","tag-medical-device-directives","tag-medical-device-industry","tag-medical-device-manufacturers","tag-medical-device-regulations","tag-medical-device-regulatory","tag-medical-devices","tag-medical-devices-directive","tag-medical-directive","tag-minimum-time-for-notified-body-assessments","tag-notified-body","tag-risk-management","tag-rules-for-certification-decisions","tag-rules-for-subcontracting","tag-sampling-of-class-iia-iib-technical-files","tag-sampling-of-technical-files","tag-team-nb","tag-unannounced-audits","tag-unannounced-inspections","tag-unannounced-visits"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2857","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=2857"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2857\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=2857"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=2857"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=2857"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}