[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_fullwidth_image src=”https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/10\/top_pharma-medizinprodukte-min.jpg” alt=”Pharma & Medizinprodukte” title_text=”Medizinprodukte” _builder_version=”4.18.1″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.17.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ custom_margin=”||0px||false|false” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.18.1″ text_font=”||||||||” text_line_height=”2em” header_font=”Manrope|600|||||||” header_text_color=”#20292f” header_line_height=”1.4em” header_2_font=”Manrope|500||on|||||” header_2_text_color=”#193b7a” header_2_font_size=”14px” header_2_letter_spacing=”1px” header_2_line_height=”1.5em” header_3_font=”Manrope|500|||||||” header_3_font_size=”20px” header_3_line_height=”1.4em” custom_margin=”0px||0px||false|false” hover_enabled=”0″ header_2_font_size_tablet=”42px” header_2_font_size_phone=”32px” header_2_font_size_last_edited=”off|desktop” header_3_font_size_tablet=”28px” header_3_font_size_phone=”20px” header_3_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.18.1″ _module_preset=”default” text_font=”Manrope||||||||” header_font=”Manrope|600|||||||” custom_margin=”0px||||false|false” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
Manufacturers in Europe must pass a conformity assessment procedure for the approval\/marking of their product. Depending on the medical device class (1-3), different conformity assessment procedures<\/strong> (quality management system QMS)<\/strong>\u00a0and a technical documentation assessment<\/strong> (Annex IX of the Medical Device Regulation EU-<\/strong>MDR<\/strong><\/a> , a type examination<\/strong> (Annex X of the MDR), and a product conformity assessment<\/strong> (Annex XI) are applied. The conformity assessment procedure is the authorization to place the product on the market with CE marking. The conformity assessment, e.g., the type examination, is carried out by Notified Bodies \/ testing institutes such as Technical Inspection Association (T\u00dcV)<\/a><\/strong>.<\/p>\n The conformity assessment procedures<\/strong> require a certified QMS<\/strong><\/a>. The establishment and maintenance of QMSs<\/strong> were originally based on the EN ISO 9001<\/strong> standard followed by EN ISO 13485: 2016 <\/strong><\/a>. With the new European MDR, a QMS is an important tool for all medical device manufacturers<\/strong> to remain competitive. For medical devices of all classes<\/strong>, manufacturers must submit the technical documentation of the medical device to a Notified Body.<\/p>\n Once you have submitted and created the Declaration of Conformity, the CE mark can be applied to your product and you can register your medical device. In Germany, the German Institute for Medical Documentation and Information (DIMDI)<\/strong><\/a> is responsible fo medical device registration. You next issue the market release and place the product with the CE mark on the market. After the product launch, you are obligated to continually monitor feedbacks and incidents from the market (risk management).<\/p>\n Legislation differs in other countries. Medical device manufacturers in the US, for example, must apply for approval from the Food and Drug Administration (FDA)<\/strong><\/a> when placing the product on the US market . <\/strong>The most important approval procedure here is premarket notification<\/strong> in accordance with 510(k) (FDA)<\/strong><\/a>. Other submission pathways are Pre Market Approval Applications (PMA)\u00a0<\/strong><\/a>with class III medical devices or DeNovo submissions<\/strong><\/a>.<\/p>\n We can help you with everything from file submission and choice of conformity procedure to obtaining CE marking and the FDA approval of your medical device.<\/p>\n Feel free to contact us!<\/p>\n [\/et_pb_text][et_pb_button button_url=”\/en\/contact” button_text=”Make a consultation appointment” _builder_version=”4.16″ _module_preset=”default” custom_button=”on” button_text_size=”13px” button_text_color=”#FFFFFF” button_bg_color=”#16918f” button_border_width=”4px” button_border_color=”#16918f” button_border_radius=”0px” button_font=”Manrope|||on|||||” button_icon=”$||divi||400″ button_icon_color=”#FFFFFF” background_layout=”dark” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" Conformity assessment & CE marking From the choice of the conformity assessment procedure to CE markingManufacturers in Europe must pass a conformity assessment procedure for the approval\/marking of their product. Depending on the medical device class (1-3), different conformity assessment procedures (quality management system QMS)\u00a0and a technical documentation assessment (Annex IX of the Medical Device […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":" [et_pb_section fb_built=\"1\" fullwidth=\"on\" _builder_version=\"4.10.7\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_fullwidth_image src=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/10\/top_pharma-medizinprodukte-min.jpg\" alt=\"Pharma & Medizinprodukte\" title_text=\"Medizinprodukte\" _builder_version=\"4.11.4\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=\"1\" _builder_version=\"4.10.7\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_row _builder_version=\"4.10.7\" custom_margin=\"||0px||false|false\" custom_padding=\"0px||0px||false|false\" locked=\"off\" global_colors_info=\"{}\"][et_pb_column type=\"4_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_text _builder_version=\"4.14.2\" text_font=\"||||||||\" text_line_height=\"2em\" header_font=\"Manrope|600|||||||\" header_text_color=\"#20292f\" header_line_height=\"1.4em\" header_2_font=\"Manrope|500||on|||||\" header_2_text_color=\"#193b7a\" header_2_font_size=\"14px\" header_2_letter_spacing=\"1px\" header_2_line_height=\"1.5em\" header_3_font=\"Manrope|500|||||||\" header_3_font_size=\"20px\" header_3_line_height=\"1.4em\" custom_margin=\"0px||0px||false|false\" hover_enabled=\"0\" header_2_font_size_tablet=\"42px\" header_2_font_size_phone=\"32px\" header_2_font_size_last_edited=\"off|desktop\" header_3_font_size_tablet=\"28px\" header_3_font_size_phone=\"20px\" header_3_font_size_last_edited=\"on|phone\" locked=\"off\" global_colors_info=\"{}\" sticky_enabled=\"0\"]<\/p> [\/et_pb_text][et_pb_text _builder_version=\"4.14.2\" _module_preset=\"default\" text_font=\"Manrope||||||||\" header_font=\"Manrope|600|||||||\" custom_margin=\"0px||||false|false\" hover_enabled=\"0\" global_colors_info=\"{}\" sticky_enabled=\"0\"]<\/p> Die Hersteller in Europa m\u00fcssen f\u00fcr die Zulassung\/Kennzeichnung ihres Produktes\u00a0ein Konformit\u00e4tsbewertungsverfahren<\/strong>\u00a0bestehen. Abh\u00e4ngig von der Medizinprodukte-Klasse werden unterschiedliche Konformit\u00e4tsbewertungsverfahren<\/strong> (Qualit\u00e4tsmanagementsystem<\/strong>\u00a0(QMS) und eine\u00a0Bewertung der technischen Dokumentation<\/strong> (Anhang IX der Medical Device Regulation (MDR)), eine Baumusterpr\u00fcfung<\/strong> (Anhang X der MDR) sowie eine Produktkonformit\u00e4tspr\u00fcfung<\/strong> (Anhang XI) angewendet. Das Konformit\u00e4tsbewertungsverfahren ist die Berechtigung, das Produkt mit CE-Kennzeichnung in den Verkehr zu bringen. Die Konformit\u00e4tspr\u00fcfung, z. B. die Baumusterpr\u00fcfung, wird durch Benannte Stellen \/ Pr\u00fcfinstitute wie den T\u00dcV durchgef\u00fchrt.<\/p> Die Konformit\u00e4tsbewertungsverfahren <\/strong>setzen zertifizierte QMS<\/strong><\/a> voraus. Die Errichtung und Aufrechterhaltung<\/strong> von QMS<\/strong>\u00a0beruhte urspr\u00fcnglich auf der Norm EN ISO 9001; sp\u00e4ter<\/strong>\u00a0folgte\u00a0EN ISO 13485<\/strong>. Mit der neuen europ\u00e4ischen MDR<\/strong>\u00a0ist ein QMS<\/strong>\u00a0f\u00fcr alle Medizinprodukte-Hersteller ein wichtiges Hilfsmittel, um wettbewerbsf\u00e4hig zu bleiben. F\u00fcr Medizinprodukte aller Klassen<\/strong> m\u00fcssen die Hersteller die\u00a0<\/strong>technische Dokumentation des Medizinproduktes<\/strong> bei einer Benannten Stelle<\/strong> einreichen.<\/p>Konformit\u00e4tsbewertung & CE-Kennzeichnung<\/h2>
Von der Wahl des Konformit\u00e4tsbewertungsverfahrens bis zur CE-Kennzeichnung<\/h1>