{"id":6467,"date":"2021-05-07T08:12:56","date_gmt":"2021-05-07T08:12:56","guid":{"rendered":"https:\/\/nora-material.de\/?p=6467"},"modified":"2021-07-05T09:58:07","modified_gmt":"2021-07-05T09:58:07","slug":"mdr-regulation","status":"publish","type":"post","link":"https:\/\/nora-material.de\/en\/produkte-en\/mdr-regulation\/","title":{"rendered":"Well prepared according to the MDR regulation (EU) 2017\/745"},"content":{"rendered":"

[vc_row][vc_column width=”5\/6″][vc_single_image image=”6468″ img_size=”full”][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/2″][vc_custom_heading text=”Well prepared according to the MDR regulation” font_container=”tag:h1|font_size:40|text_align:right” use_theme_fonts=”yes” css=”.vc_custom_1620309868123{padding-bottom: 10px !important;}”][\/vc_column][vc_column width=”1\/2″][vc_column_text]The European\u00a0Medical Device Regulation (EU) 2017\/745 (MDR)<\/a> replaces the Medical Device Directive (93\/42 \/ EEC) and was published in May 2017. The transition period originally lasted 3 years. Because of the COVID-19 pandemic, the EU Commission extended this transition period. Therefore, the start of validity is now May 26, 2021.[\/vc_column_text][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/2″][vc_column_text]Under the MDR (Medical Device Regulation, EU Regulation 2017\/745), materials<\/a> used for the production of medical products must be provided, amongst others, with a declaration of clearance<\/strong> with respect to their toxicological properties.<\/p>\n

\"\u2714\"\u00a0nora\u00ae<\/sup> products are free of constituents posing toxicological and carcinogenic risks as set down under EU Regulation 2017\/745.\u00a0<\/strong><\/p>\n

\"\u2714\"\u00a0Owing to their properties, nora\u00ae<\/sup> materials are suitable for the processing of Class 1 medical products.\u00a0<\/strong><\/p>\n

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Safe & proven<\/h3>\n

The closed-cell surface structure of the EVA foam also minimises the risk of harm to health in the form of germ and bacterial colonies and facilitates complete hygienic cleaning and disinfection<\/strong>.<\/p>\n

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Important aspects of our EVA foam:<\/strong><\/p>\n

\"\u2714\" dermatologically tested skin compatibility\u00a0“excellent”<\/p>\n

\"\u2714\" proven disinfectability<\/p>\n

\"\u2714\" phthalate-free and latex-free<\/p>\n

\"\u2714\" SG pollutant tested<\/p>\n

\"\u2714\" batch tracking<\/p>\n

\"\u2714\" proven cytotoxicity under ISO 10993[\/vc_column_text][\/vc_column][vc_column width=”1\/2″]