{"id":6877,"date":"2019-02-09T10:39:46","date_gmt":"2019-02-09T09:39:46","guid":{"rendered":"https:\/\/productosanitario.es\/compliance-ce-marking-of-medical-devices\/"},"modified":"2025-03-07T17:36:08","modified_gmt":"2025-03-07T16:36:08","slug":"compliance-ce-marking-of-medical-devices","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/compliance-ce-marking-of-medical-devices\/","title":{"rendered":"Compliance. CE marking of medical devices"},"content":{"rendered":"\t\t
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Compliance. CE marking of medical devices<\/b><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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A requirement of the regulation that obliges the company, and the medical device, to comply with all applicable requirements in relation to the classification and intended purpose of the device. Compliance with requirements is the fundamental principle on which CE marking grows, in this case, for medical devices.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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These are two terms that cannot be dissociated, that will never be separated and that always go together. The CE marking<\/strong><\/a> is the process by which compliance with the requirements applicable to the product is documented and verified, and the term regulatory compliance <\/a>is responsible for condensing the ability to comply with any of the requirements applicable to any medical device<\/a><\/strong>, regardless of its origin, whether legislative, regulatory, technical, of customer or any other foreseeable.<\/p>

It will be the responsibility of the company to identify what the requirements are that apply to its product, as well as to itself as an economic agent in the medical device<\/strong> sector.<\/p>

In the case of medical device manufacturing companies, they must put the medical device on the market with CE marking<\/strong> , and the rest of the economic agents (distributor, importer or authorised representative) are responsible for ensuring that the product with which they have a relationship has it.<\/p>

The requirements applicable to the medical device depend, to a large extent, on the properties and characteristics of the device itself. The requirements applicable to the specific device will depend mainly on its classification as a medical device, its intended purpose, its risk analysis<\/a> and its clinical evaluation<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Quality Management<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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One of the common requirements for all of them will be to have an adequate quality management system, which will be the main tool that the company uses to achieve the objective, the regulatory compliance of the medical device.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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At PS Consulting<\/b> we are specialists in medical device consulting, contact us if you need help and we will find the best solution.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Blog<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Compliance. CE marking of medical devices A requirement of the regulation that obliges the company, and the medical device, to comply with all applicable requirements in relation to the classification and intended purpose of the device. Compliance with requirements is the fundamental principle on which CE marking grows, in this case, for medical devices. These […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-6877","page","type-page","status-publish","hentry"],"yoast_head":"\nCompliance. 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