The ruler is a class 1 medical device classified by the BfArM and registered with the German Medical Devices Information and Database System (DMIDS) according to \u00a7 3 MDR.<\/p>\n
According to the Medical Device User Reporting and Information Ordinance (MPAMIV), both the manufacturer and the user are obliged to report incidents related to the use of the medical device.<\/p>\n
Definition: “An incident is a malfunction, failure, or change in characteristics or performance, or an inadequacy in the labeling or instructions for use of a medical device that has resulted, may have resulted, or could result, directly or indirectly, in the death or serious deterioration of the health of a patient, user, or other person.”<\/p>\n
To report incidents, please contact the manufacturer (see above) or the Federal Institute for Drugs and Medical Devices(www.BfArM.de)<\/a>. <\/a><\/p>\n As a class 1 medical device, the ruler was approved according to \u00a7 6 para. 1 MDR tested by the manufacturer according to the EC conformity assessment procedure and provided with a CE seal. All recommendations made on the ruler are in accordance with the currently valid guidelines or recommendations and\/or manufacturer’s specifications. Details in this regard are available from the manufacturer.<\/p>\n Registered design No 002909382-0001, Office for Harmonization in the Internal Market – OHIM.<\/p>\n","protected":false},"excerpt":{"rendered":" Medical device The ruler is a class 1 medical device classified by the BfArM and registered with the German Medical Devices Information and Database System (DMIDS) according to \u00a7 3 MDR. Incidents According to the Medical Device User Reporting and Information Ordinance (MPAMIV), both the manufacturer and the user are obliged to report incidents related […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3278","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/paeder.com\/en\/wp-json\/wp\/v2\/pages\/3278","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/paeder.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/paeder.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/paeder.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/paeder.com\/en\/wp-json\/wp\/v2\/comments?post=3278"}],"version-history":[{"count":0,"href":"https:\/\/paeder.com\/en\/wp-json\/wp\/v2\/pages\/3278\/revisions"}],"wp:attachment":[{"href":"https:\/\/paeder.com\/en\/wp-json\/wp\/v2\/media?parent=3278"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}CE certification<\/h4>\n
European design<\/h4>\n