The turbulent times we are experiencing, when the demand for sanitary products has skyrocketed, have highlighted the importance of having standards that guarantee the quality of these products.<\/p>\n
A medical device is defined as \u201cany instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by the manufacturer specifically for diagnostic and\/or therapeutic purposes and that are instrumental in its proper functioning, intended by the manufacturer to be used in humans for the purposes of:<\/strong><\/p>\n (Royal Decree 1591\/2009)<\/strong><\/em><\/p>\n Medical devices are regulated by common standards across the European Union, and CE marking by the manufacturer certifies that the product complies with all this legislation. As is the case with work equipment, a medical device that does not have this seal cannot be marketed within the European market.<\/p>\n The CE sanitary marking guarantees that a product has been manufactured and is intended for use in accordance with the safety and quality regulations established by the European Union. A product with this mark will have the appropriate technical documentation, will have been tested and evaluated, will comply with the relevant legislation and will have a quality assurance system.<\/p>\n The medical CE marking<\/strong> It is a complex process involving numerous regulations and directives. For the process to be efficient, it is very useful to have the advice and support of a company with extensive experience in the management of sanitary CE marking, such as Grupo TICE.<\/p>\n First of all, the product must be classified. Depending on the classification, different regulations will be considered for obtaining certification. The next step will be to obtain the manufacturing or import licence, in the case of seeking to market a product that has not been manufactured by us. Subsequently, the clinical evaluation is carried out and, following that, laboratory tests. At this point, the product's \u2018Technical file\u2019 is compiled, and finally, the necessary quality system is implemented to comply with all regulations relating to medical devices.<\/strong><\/p>\n After the satisfactory resolution of all these phases, the CE sanitary mark is obtained.<\/strong><\/p>","protected":false},"excerpt":{"rendered":" Los tiempos convulsos que atravesamos, cuando la demanda de productos sanitarios se ha disparado, han puesto en valor la importancia de contar normas que garanticen la calidad de estos productos. \u00bfA qu\u00e9 llamamos productos sanitarios? Se denomina producto sanitario a \u201ccualquier instrumento, dispositivo, equipo, programa inform\u00e1tico, material u otro art\u00edculo, utilizado solo o en combinaci\u00f3n, […]<\/p>\n","protected":false},"author":7,"featured_media":1811,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[79],"tags":[],"class_list":["post-1810","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-marcado-ce"],"yoast_head":"\n\n
What does the health CE guarantee?<\/h2>\n
How do you get the health certificate?<\/h2>\n
What steps do we need to follow to obtain CE marking for medical devices?<\/h2>\n