{"id":91596470506,"date":"2024-11-28T08:50:42","date_gmt":"2024-11-28T07:50:42","guid":{"rendered":"https:\/\/neue-augen.de\/medical-device-safety\/"},"modified":"2024-11-28T08:50:42","modified_gmt":"2024-11-28T07:50:42","slug":"medical-device-safety","status":"publish","type":"page","link":"https:\/\/neue-augen.de\/en\/medical-device-safety\/","title":{"rendered":"Medical Device Safety"},"content":{"rendered":"\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-group is-style-default is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-group is-style-highlight is-layout-constrained wp-block-group-is-layout-constrained\"><h1 class=\"wp-block-heading\" id=\"medical-device-safety\">Medical Device Safety<\/h1>\n\n\n<p>We ensure more safety \u2013 <strong>Ordinance on the Construction, Operation and Application of Medical Devices (Medical Devices Operator Ordinance \u2014 MPBetreibV) \u00a7 6 Commissioner for Medical Device Safety<\/strong><\/p>\n\n\n\n<p>Healthcare facilities with regularly more than 20 employees must ensure that a competent and reliable person with medical, scientific, nursing, pharmaceutical, or technical training is designated as the Commissioner for Medical Device Safety.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-style-highlight is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-group is-content-justification-left is-layout-constrained wp-container-core-group-is-layout-12dd3699 wp-block-group-is-layout-constrained\"><h2 class=\"wp-block-heading has-text-align-center\" id=\"tasks\">Tasks<\/h2>\n\n\n<p><br>The Commissioner for Medical Device Safety serves as the central point in the health facility and performs the following tasks for the operator:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>acting as the contact person for authorities, manufacturers, and distributors regarding reports of medical device risks and the implementation of necessary corrective measures<\/li>\n\n\n\n<li>coordinating the health facility\u2019s internal processes to fulfil the reporting and cooperation obligations of users and operators, and<\/li>\n\n\n\n<li>coordinating the implementation of corrective actions and recalls by the person responsible under \u00a7 5 of the Medical Devices Act within healthcare institutions<\/li>\n<\/ol>\n\n\n\n<p>Source: \u00a7 6 paras. 1 and 2 MPBetrV in the version of 01.01.2017.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-group is-style-highlight is-content-justification-left is-layout-constrained wp-container-core-group-is-layout-12dd3699 wp-block-group-is-layout-constrained\"><h2 class=\"wp-block-heading has-text-align-center\" id=\"do-you-have-any-questions\">Do you have any questions?<\/h2>\n\n\n<p>Our Commissioner for Medical Device Safety can be reached at the following e\u2011mail address.<\/p>\n\n\n\n<p>Contact: <a href=\"mailto:medizinprodukte@neue-augen.de\">medizinprodukte@neue-augen.de<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Medical Device Safety We ensure more safety \u2013 Ordinance on the Construction, Operation and Application of Medical Devices (Medical Devices Operator Ordinance \u2014 MPBetreibV) \u00a7 6 Commissioner for Medical Device Safety Healthcare facilities with regularly more than 20 employees must ensure that a competent and reliable person with medical, scientific, nursing, pharmaceutical, or technical training [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":6,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-91596470506","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/neue-augen.de\/en\/wp-json\/wp\/v2\/pages\/91596470506","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/neue-augen.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/neue-augen.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/neue-augen.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/neue-augen.de\/en\/wp-json\/wp\/v2\/comments?post=91596470506"}],"version-history":[{"count":0,"href":"https:\/\/neue-augen.de\/en\/wp-json\/wp\/v2\/pages\/91596470506\/revisions"}],"wp:attachment":[{"href":"https:\/\/neue-augen.de\/en\/wp-json\/wp\/v2\/media?parent=91596470506"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}