{"id":596,"date":"2024-11-22T10:39:30","date_gmt":"2024-11-22T10:39:30","guid":{"rendered":"https:\/\/newmeden.sviluppokeyweb.com\/certificazione-europea-dispositivi-medici-e-marcatura-ce\/"},"modified":"2025-02-07T07:54:10","modified_gmt":"2025-02-07T07:54:10","slug":"u-medical-device-certification-and-ce-marking","status":"publish","type":"page","link":"https:\/\/www.newmedconsulting.com\/en\/u-medical-device-certification-and-ce-marking\/","title":{"rendered":"EU MEDICAL DEVICE CERTIFICATION AND CE MARKING"},"content":{"rendered":"

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COMPLIANCE WITH EUROPEAN REGULATIONS<\/strong><\/h1>\n

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Effective planning<\/strong> is essential to meet the European requirements<\/strong> that regulate this sector. Every medical device placed on the market must comply with highly specific European regulation requirements<\/strong> to obtain CE marking<\/strong>, which is fundamental for commercializing your product in the European Union and, therefore, also in Italy<\/p>\n

This is why you should rely on us<\/strong>: from our in-depth study and with our expertise, we will be able to guide you<\/strong> in the correct procedure to comply with European regulations<\/strong> and obtain the CE marking<\/strong>, ensuring that your product meets the requirements<\/p>\n

Find out how we can help you: fill out the form now!<\/strong><\/p>\n

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European Commission<\/p>\n

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EU Regulation 2017\/745 MDR<\/p>\n

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Italian Ministry of Health<\/p>\n

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max_width_tablet=”90%” max_width_phone=”90%” max_width_last_edited=”on|phone” custom_margin=”|auto|-11px|auto||” custom_padding=”104px||66px|||” animation_style=”fade” animation_delay=”400ms” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”Roboto|300|||||||” text_text_color=”#ffffff” text_font_size=”42px” text_line_height=”1.2em” header_font=”–et_global_heading_font||||||||” header_text_color=”#000000″ custom_margin=”-12px||||false|false” custom_margin_tablet=”-22px||||false|false” custom_margin_phone=”-22px||||false|false” custom_margin_last_edited=”on|phone” hover_enabled=”0″ text_font_size_tablet=”” text_font_size_phone=”25px” text_font_size_last_edited=”on|phone” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

WITH YOU EVEN AFTER ACHIEVING CERTIFICATION<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”||||||||” text_text_color=”#000000″ text_font_size=”15px” text_line_height=”1.5em” custom_margin=”1px||||false|false” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”0px||||false|false” custom_margin_last_edited=”on|phone” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

We firmly believe in the continuity<\/strong> of the journey we have undertaken together, which extends beyond the phases of consultation, design, production, and ultimately marketing of the medical product<\/p>\n

Our service<\/strong> continues with the post-marketing phase<\/strong>, where we monitor the safety of your device after it is placed on the market. This type of surveillance can help further refine the medical device thanks to feedback from users<\/p>\n

Finally, we offer our support <\/strong>during both internal and external technical and inspection audits<\/strong>, which are carried out by Competent Authorities, Certification Bodies and Notified Bodies<\/strong>. This type of check is carried out with variable frequency, but thanks to our assistance you will be able to discover how to best prepare yourself<\/p>\n

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Would you like more information?
<\/strong>Contact us, our team is at your service.<\/p>\n

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Contact us<\/p>\n

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