[et_pb_section fb_built=”1″ _builder_version=”4.26.0″ _module_preset=”default” background_image=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2024\/09\/Servicios-4.png” min_height=”400px” locked=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.26.0″ _module_preset=”default” custom_margin=”100px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” header_font=”–et_global_heading_font|700|||||||” header_font_size=”48px” text_text_shadow_style=”preset3″ text_text_shadow_color=”rgba(209,209,209,0.4)” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” header_font=”–et_global_heading_font|700|||||||” header_text_color=”#009ee3″ header_font_size=”48px” custom_margin=”-20px||||false|false” header_text_shadow_style=”preset3″ header_text_shadow_color=”rgba(209,209,209,0.4)” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_row column_structure=”2_5,3_5″ _builder_version=”4.26.0″ _module_preset=”default” custom_padding=”40px|40px|40px|40px|false|false” border_radii=”on|4px|4px|4px|4px” border_width_all=”2px” border_color_all=”#009ee3″ locked=”off” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2025\/01\/GettyImages-107429856.jpg” title_text=”GettyImages-107429856″ _builder_version=”4.26.0″ _module_preset=”default” border_radii=”on|2px|2px|2px|2px” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
Outside of medical devices, there are a wide range of products that promise to improve people’s quality of life in a variety of ways. These products are not necessarily intended to treat, prevent or diagnose disease as are medical devices. There are products that, while they may have a relationship to health or wellness, do not have a medical purpose in the strictest sense. These are known as <\/span>non-medical products<\/span><\/i> o <\/span>non-medical products<\/span><\/i>. Although they are not intended to be used for medical purposes, it is essential that these products comply with regulations and standards to ensure their safety and quality. <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.26.0″ _module_preset=”default” background_image=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2024\/08\/vertical-blog-scaled.jpg” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.26.0″ _module_preset=”default” border_color_all=”#009ee3″ locked=”off” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n For the European Commission, the marketing of these products must be regulated just as medical devices are regulated. Therefore, MDR 2017\/745 includes a specific section explaining what requirements they must meet. Annex XVI describes what must be included in the <\/span>technical documentation for Annex XVI products<\/span><\/i>. As in all cases, regulation plays a crucial role in ensuring that non-medical products are safe and effective for consumers, which is a larger population target than any medical device. It is therefore very important to know what non-medical devices are, why technical documentation is crucial for these products, and how the MDR 2017\/745 regulation helps to ensure that these products are marketed responsibly. <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2025\/01\/GettyImages-2186497419.jpg” title_text=”GettyImages-2186497419″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” header_3_font=”Arial||||||||” header_3_font_size=”32px” locked=”off” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ disabled_on=”on|on|off” _builder_version=”4.26.0″ _module_preset=”default” background_image=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2025\/01\/GettyImages-2186917236.jpg” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” background_color=”#FFFFFF” custom_padding=”40px|40px|40px||false|false” animation_style=”slide” animation_direction=”left” animation_delay=”150ms” global_colors_info=”{}”]<\/p>\n The first question that arises when addressing the subject of non-medical <\/span>non-medical products<\/span><\/i> is: what distinguishes them from medical products? The key difference lies in the purpose for which they are intended. Medical products are specifically designed to treat, diagnose, prevent or alleviate disease, whereas <\/span>non-medical products<\/span><\/i> are not intended for this purpose.<\/span><\/p>\n This group includes a wide variety of products, such as cosmetics, wellness devices, personal care items, dietary supplements, among others. Although these products may have beneficial effects on a person’s health or well-being, they are not intended to treat medical conditions or directly influence the diagnosis or treatment of disease. A common example of <\/span>non-medical products<\/span><\/i> would be cosmetic creams that improve the appearance of the skin or fitness devices that help monitor physical activity without having a therapeutic purpose.<\/span><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ disabled_on=”off|off|on” _builder_version=”4.26.0″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2024\/12\/back-img-over-2.png” title_text=”GettyImages-2186917236″ _builder_version=”4.26.0″ _module_preset=”default” background_image=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2025\/01\/GettyImages-2186917236.jpg” max_height=”200px” animation_style=”slide” animation_direction=”right” animation_delay=”100ms” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” animation_style=”slide” animation_direction=”left” animation_delay=”150ms” global_colors_info=”{}”]<\/p>\n The first question that arises when addressing the subject of non-medical <\/span>non-medical products<\/span><\/i> is: what distinguishes them from medical products? The key difference lies in the purpose for which they are intended. Medical products are specifically designed to treat, diagnose, prevent or alleviate disease, whereas <\/span>non-medical products<\/span><\/i> are not intended for this purpose.<\/span><\/p>\n This group includes a wide variety of products, such as cosmetics, wellness devices, personal care items, dietary supplements, among others. Although these products may have beneficial effects on a person’s health or well-being, they are not intended to treat medical conditions or directly influence the diagnosis or treatment of disease. A common example of <\/span>non-medical products<\/span><\/i> would be cosmetic creams that improve the appearance of the skin or fitness devices that help monitor physical activity without having a therapeutic purpose.<\/span><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.26.0″ _module_preset=”default” custom_padding=”0px||||false|false” global_colors_info=”{}”][et_pb_row _builder_version=”4.26.0″ _module_preset=”default” custom_margin=”0px||||false|false” custom_padding=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” header_3_font=”Arial||||||||” header_3_font_size=”32px” locked=”off” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ disabled_on=”on|on|off” _builder_version=”4.26.0″ _module_preset=”default” background_image=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2025\/01\/GettyImages-2183257695.jpg” custom_margin=”||||false|false” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” background_color=”#FFFFFF” custom_padding=”40px||40px|40px|false|false” animation_style=”slide” animation_direction=”right” animation_duration=”1100ms” hover_enabled=”0″ global_colors_info=”{}” custom_margin=”|-1px|||false|false” sticky_enabled=”0″]<\/p>\n Although non-medical <\/span>non-medical products<\/span><\/i> are not intended to treat diseases, their marketing is regulated by the competent authorities to ensure that they are safe for consumer use. A crucial part of this regulation is that described in the <\/span>Annex XVI of the MDR<\/span><\/i>which is a set of requirements and guidelines that manufacturers must follow to ensure that their products meet safety and quality standards.<\/span><\/p>\n The <\/span>technical documentation<\/span><\/i> which is used to evidence compliance with the requirements of the European regulation, includes all the information that the manufacturer must gather to demonstrate that its product complies with the regulations and is designed, manufactured and distributed according to the highest standards of quality and safety. Although the technical documentation described in the MDR is primarily associated with medical devices, some products that do not have a direct medical purpose are also subject to these requirements if they present a potential risk to the user’s health or are otherwise health-related. <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ disabled_on=”off|off|on” _builder_version=”4.26.0″ _module_preset=”default” custom_margin=”20px||||false|false” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2024\/12\/back-img-over-2.png” title_text=”GettyImages-2183257695″ _builder_version=”4.26.0″ _module_preset=”default” background_image=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2025\/01\/GettyImages-2183257695.jpg” max_height=”200px” animation_style=”slide” animation_direction=”left” animation_duration=”1100ms” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” background_enable_color=”off” animation_style=”slide” animation_direction=”right” animation_duration=”1100ms” global_colors_info=”{}”]<\/p>\n Although non-medical <\/span>non-medical products<\/span><\/i> are not intended to treat diseases, their marketing is regulated by the competent authorities to ensure that they are safe for consumer use. A crucial part of this regulation is that described in the <\/span>Annex XVI of the MDR<\/span><\/i>which is a set of requirements and guidelines that manufacturers must follow to ensure that their products meet safety and quality standards.<\/span><\/p>\n The <\/span>technical documentation<\/span><\/i> which is used to evidence compliance with the requirements of the European regulation, includes all the information that the manufacturer must gather to demonstrate that its product complies with the regulations and is designed, manufactured and distributed according to the highest standards of quality and safety. Although the technical documentation described in the MDR is primarily associated with medical devices, some products that do not have a direct medical purpose are also subject to these requirements if they present a potential risk to the user’s health or are otherwise health-related. <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.26.0″ _module_preset=”default” background_color=”rgba(0,193,193,0.07)” locked=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” header_3_font=”Arial||||||||” header_3_font_size=”32px” locked=”off” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ disabled_on=”on|on|off” _builder_version=”4.26.0″ _module_preset=”default” background_enable_image=”off” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” background_enable_color=”off” custom_padding=”||||false|false” animation_style=”slide” animation_direction=”left” animation_delay=”150ms” global_colors_info=”{}”]<\/p>\n When referring to Annex XVI products <\/span>Annex XVI<\/span><\/i> refers to a specific set of products that, although not intended for medical purposes, may have implications for the health and well-being of consumers.<\/span><\/p>\n Contact lenses or other items intended to be inserted or placed in the eye.<\/span><\/p>\n Products intended to be wholly or partially introduced into the human body by invasive surgical means for the purpose of modifying the anatomy or fixation of parts of the body, with the exception of products for tattooing and piercing. This group includes, among others, breast prostheses for aesthetic purposes. <\/span><\/p>\n <\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n Substances, combinations of substances or articles intended for use as facial fillers, or in other dermal or mucous membrane areas, by subcutaneous, submucosal or intradermal injection or by other means of introduction, excluding those intended for tattooing. This annex establishes the requirements for the technical documentation that must accompany such products before they can be placed on the European market. <\/span><\/span><\/p>\n In order to comply with the regulation, the <\/span>technical documentation<\/span><\/i> must include, among other things:<\/span><\/p>\n <\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” header_2_text_color=”#0C71C3″ header_2_font_size=”40px” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” custom_margin=”-20px||||false|false” custom_padding=”0px||||false|false” global_colors_info=”{}”]<\/p>\n Detailed product description<\/b>:<\/span><\/p>\n This includes a full explanation of the product’s function, its features, and any other relevant information about its design and manufacture. It is essential that the manufacturer explains how the product works, what it is intended for, and why it is not considered a medical product. <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” header_2_text_color=”#0C71C3″ header_2_font_size=”40px” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” custom_margin=”-20px||||false|false” global_colors_info=”{}”]<\/p>\n Risk assessment<\/b>:<\/span><\/p>\n Although non-medical products are not intended to treat disease, it is crucial to identify any potential health risks that may arise from their use. This includes assessing any adverse effects the product may have on the skin, body or environment. Risk assessment helps to identify potential hazards and establish appropriate mitigation measures. <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” header_2_text_color=”#0C71C3″ header_2_font_size=”40px” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” custom_margin=”-20px||||false|false” global_colors_info=”{}”]<\/p>\n Safety tests<\/b>:<\/span><\/p>\n Manufacturers should provide evidence that the product has been subjected to tests that demonstrate its safety under normal conditions of use. This may include tests for toxicity, stability, resistance and other aspects related to the safety of the product. <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” header_2_text_color=”#0C71C3″ header_2_font_size=”40px” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” custom_margin=”-20px||||false|false” global_colors_info=”{}”]<\/p>\n Instructions for use and labeling<\/b>:<\/span><\/p>\n The technical documentation should also include clear information on how to use the product safely. This is especially important for products that could present risks if not used correctly, such as electronic devices or personal care products. Labels should be clear, informative and comply with market product labeling regulations. <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” header_2_text_color=”#0C71C3″ header_2_font_size=”40px” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” custom_margin=”-20px||||false|false” global_colors_info=”{}”]<\/p>\n Declaration of Conformity<\/b>:<\/span><\/p>\n This is a manufacturer’s declaration that the product complies with all applicable regulatory requirements. The manufacturer assumes responsibility that the product has been designed and manufactured in accordance with safety and quality regulations. <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.26.0″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” header_3_font=”Arial||||||||” header_3_font_size=”32px” locked=”off” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ disabled_on=”on|on|off” _builder_version=”4.26.0″ _module_preset=”default” background_image=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2025\/01\/GettyImages-2183257234.jpg” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” background_color=”#FFFFFF” custom_padding=”40px|40px|40px||false|false” animation_style=”slide” animation_direction=”left” animation_delay=”150ms” global_colors_info=”{}”]<\/p>\n In the European Union, non-medical <\/span>non-medical products<\/span><\/i> are subject to regulations that guarantee their safety and quality. EU legislation establishes that any product placed on the market must comply with the requirements set out in the <\/span>Regulation (EU) 2017\/745<\/span><\/i>which regulates medical products. This regulatory framework is applicable to non-medical products, as they must also ensure consumer safety. <\/span><\/p>\n In addition, the <\/span>Annex XVI<\/span><\/i> provides a specific regulatory framework for certain non-medical products that may have an impact on health or well-being. Products falling under this annex must undergo a thorough evaluation before being placed on the market, and manufacturers must submit all technical documentation demonstrating that the product complies with safety and quality regulations. <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ disabled_on=”off|off|on” _builder_version=”4.26.0″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2024\/12\/back-img-over-2.png” title_text=”GettyImages-2183257234″ _builder_version=”4.26.0″ _module_preset=”default” background_image=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2025\/01\/GettyImages-2183257234.jpg” max_height=”200px” animation_style=”slide” animation_direction=”right” animation_delay=”100ms” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” animation_style=”slide” animation_direction=”left” animation_delay=”150ms” global_colors_info=”{}”]<\/p>\n In the European Union, non-medical <\/span>non-medical products<\/span><\/i> are subject to regulations that guarantee their safety and quality. EU legislation establishes that any product placed on the market must comply with the requirements set out in the <\/span>Regulation (EU) 2017\/745<\/span><\/i>which regulates medical products. This regulatory framework is applicable to non-medical products, as they must also ensure consumer safety. <\/span><\/p>\n In addition, the <\/span>Annex XVI<\/span><\/i> provides a specific regulatory framework for certain non-medical products that may have an impact on health or well-being. Products falling under this annex must undergo a thorough evaluation before being placed on the market, and manufacturers must submit all technical documentation demonstrating that the product complies with safety and quality regulations. <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.26.0″ _module_preset=”default” custom_padding=”0px||||false|false” locked=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.26.0″ _module_preset=”default” custom_margin=”0px||||false|false” custom_padding=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” header_3_font=”Arial||||||||” header_3_font_size=”32px” locked=”off” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ disabled_on=”on|on|off” _builder_version=”4.26.0″ _module_preset=”default” background_image=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2025\/01\/GettyImages-950928592.jpg” custom_margin=”||||false|false” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” background_color=”#FFFFFF” custom_padding=”40px||40px|40px|false|false” animation_style=”slide” animation_direction=”right” animation_duration=”1100ms” hover_enabled=”0″ global_colors_info=”{}” custom_margin=”|-1px|||false|false” sticky_enabled=”0″]<\/p>\n Correctly draft the technical <\/span>technical documentation for Annex XVI products<\/span><\/i> plays a fundamental role in the process of marketing non-medical products. First, it ensures that products are safe for consumer use. Second, it protects manufacturers from potential legal risks by demonstrating that they have complied with the relevant regulations. It also helps maintain consumer confidence by providing evidence that the product has been evaluated and approved to the most rigorous standards. <\/span><\/p>\n In addition, having up to date technical documentation in compliance with European regulations is essential in the case of regulatory audits or safety inspections by the Spanish Agency for Medicinal Products and Medical Devices.<\/span> Spanish Agency of Medicines and Medical Devices (Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios).<\/span><\/a>. If a product is subject to a review by the competent authorities, having all the appropriate documentation can speed up the approval process and avoid legal problems or product recalls. <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ disabled_on=”off|off|on” _builder_version=”4.26.0″ _module_preset=”default” custom_margin=”20px||||false|false” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2024\/12\/back-img-over-2.png” title_text=”GettyImages-950928592″ _builder_version=”4.26.0″ _module_preset=”default” background_image=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2025\/01\/GettyImages-950928592.jpg” max_height=”200px” animation_style=”slide” animation_direction=”left” animation_duration=”1100ms” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” background_enable_color=”off” animation_style=”slide” animation_direction=”right” animation_duration=”1100ms” global_colors_info=”{}”]<\/p>\nWhat are non-medical products?<\/b><\/span><\/h3>\n
The importance of technical documentation for non-medical products<\/b><\/strong><\/h3>\n
What is covered by the technical documentation according to Annex XVI?<\/b><\/span><\/h3>\n
1<\/strong><\/span><\/h2>\n
2<\/strong><\/span><\/h2>\n
3<\/strong><\/span><\/h2>\n
4<\/strong><\/span><\/h2>\n
5<\/strong><\/span><\/h2>\n
Regulation of non-medical products in the European Union<\/b><\/span><\/h3>\n
Why is technical documentation so important?<\/b><\/strong><\/h3>\n