{"id":281975,"date":"2025-09-17T11:57:13","date_gmt":"2025-09-17T11:57:13","guid":{"rendered":"https:\/\/pass4ce.2fcom.me\/pass4ce-en\/"},"modified":"2025-11-21T14:25:37","modified_gmt":"2025-11-21T14:25:37","slug":"pass4ce-en","status":"publish","type":"page","link":"https:\/\/www.pass4ce.eu\/en\/","title":{"rendered":"Pass4CE"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;45deg&#8221; background_color_gradient_stops=&#8221;#f5f3f3 24%|rgba(245,243,243,0.27) 100%&#8221; background_color_gradient_overlays_image=&#8221;on&#8221; background_image=&#8221;https:\/\/pass4ce.eu\/wp-content\/uploads\/2025\/09\/immagine-home-pass4ce.png&#8221; positioning=&#8221;none&#8221; position_origin_a=&#8221;top_center&#8221; position_origin_f=&#8221;top_center&#8221; custom_padding=&#8221;150px||150px||true|false&#8221; 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We provide tailored technical and legislative consultancy, guiding our clients through every stage \u2014 from product design to full regulatory compliance. 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global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_heading title=&#8221;Strumenti Qualit\u00e0 e Misure srl&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; title_level=&#8221;h2&#8243; global_colors_info=&#8221;{}&#8221;][\/et_pb_heading][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]SQM operates worldwide and offers a comprehensive range of Technical and Legal Services designed to ensure the effective compliance of products with the requirements of the Directives that mandate CE Marking.[\/et_pb_text][et_pb_button button_url=&#8221;@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjIwIiwiZW5hYmxlX2h0bWwiOiJvZmYifX0=@&#8221; button_text=&#8221;Learn More&#8221; _builder_version=&#8221;4.27.4&#8243; 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_module_preset=&#8221;default&#8221; text_orientation=&#8221;center&#8221; global_colors_info=&#8221;{}&#8221;]Everything you need to know: clear and quick answers to your most common questions.[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; width_tablet=&#8221;&#8221; width_phone=&#8221;90%&#8221; width_last_edited=&#8221;on|phone&#8221; global_module=&#8221;6752&#8243; saved_tabs=&#8221;all&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_accordion closed_toggle_text_color=&#8221;#252B42&#8243; toggle_icon=&#8221;&#x4c;||divi||400&#8243; icon_color=&#8221;#252B42&#8243; use_icon_font_size=&#8221;on&#8221; icon_font_size=&#8221;20px&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_accordion_item title=&#8221;What is the European conformity of a product?&#8221; open=&#8221;on&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]European conformity means that a product meets the essential safety, health and environmental protection requirements established by EU directives and regulations.[\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;What is the CE marking?&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; open=&#8221;off&#8221;]The CE mark (Conformit\u00e9 Europ\u00e9enne) is the manufacturer\u2019s self-certification that the product complies with all applicable European regulations and standards.[\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;Which products require the CE marking?&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; open=&#8221;off&#8221;]<\/p>\n<p>The CE marking is mandatory for various products, including:<\/p>\n<ul>\n<li>Medical devices<\/li>\n<li>Toys<\/li>\n<li>Electrical and electronic equipment<\/li>\n<li>Construction products<\/li>\n<li>Machinery<\/li>\n<li>PPE (Personal Protective Equipment)<\/li>\n<li>Measuring instruments<\/li>\n<\/ul>\n<p>[\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;How is CE conformity obtained?&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; open=&#8221;off&#8221;]<\/p>\n<p>The process varies depending on the product and the applicable legislation, but generally includes:<\/p>\n<ul>\n<li>Identification of applicable directives and harmonized standards<\/li>\n<li>Conformity assessment (laboratory tests, risk analysis, etc.)<\/li>\n<li>Preparation of the technical file<\/li>\n<li>Drafting of the EU Declaration of Conformity<\/li>\n<\/ul>\n<p>Affixing of the CE marking<\/p>\n<p>[\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;Who is responsible for CE conformity?&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; open=&#8221;off&#8221;]<\/p>\n<p>The <strong>manufacturer<\/strong> is primarily responsible, but importers and distributors also have verification obligations before placing a product on the EU market.<\/p>\n<p>[\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;Which documents are required to demonstrate conformity?&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; open=&#8221;off&#8221;]<\/p>\n<ul>\n<li><strong>Technical file <\/strong>(including drawings, diagrams, tests, and risk assessments)<\/li>\n<li><strong>EU Declaration of Conformity <\/strong>(signed by the manufacturer)<\/li>\n<li><strong>Certificates from notified bodies<\/strong> (if required by legislation)<\/li>\n<\/ul>\n<p>[\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;Can a product without the CE mark be sold in Europe?&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; open=&#8221;off&#8221;]<\/p>\n<p>No. If a product falls within categories subject to CE marking, it cannot be sold within the EU without conformity.<\/p>\n<p>[\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;What happens if a product is non-compliant?&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; open=&#8221;off&#8221;]<\/p>\n<p>Market surveillance authorities may:<\/p>\n<ul>\n<li>Prevent the product from being sold<\/li>\n<li>Withdraw it from the market<\/li>\n<li>Impose sanctions on the manufacturer, importer, or distributor<\/li>\n<\/ul>\n<p>[\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;Where can I find the applicable EU legislation for my product?&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; open=&#8221;off&#8221;]<\/p>\n<p>EU directives and regulations are available on the<strong> European Commission\u2019s<\/strong> website and in the standards documents issued by organizations such as <strong>CEN, CENELEC, and ETSI.<\/strong><\/p>\n<p>[\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;What is the difference between directives and regulations?&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; open=&#8221;off&#8221;]<\/p>\n<ul>\n<li><strong>Directives: <\/strong>Must be transposed into national law by each EU Member State.<\/li>\n<li><strong>Regulations: <\/strong>Are directly applicable throughout the EU without the need for national implementation.<\/li>\n<\/ul>\n<p>[\/et_pb_accordion_item][\/et_pb_accordion][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; width=&#8221;60%&#8221; width_tablet=&#8221;80%&#8221; width_phone=&#8221;90%&#8221; width_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_heading title=&#8221;Latest News&#8221; _builder_version=&#8221;4.27.4&#8243; 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