{"product_id":"technical-file-for-medical-devices","title":"CE Technical File for Medical Devices – MDR (EU) 2017\/745 | Editable Template","description":"\u003ch2\u003eCE Technical File for Medical Devices\u003c\/h2\u003e\n\u003cp\u003eThis complete, editable CE technical file is designed for manufacturers of \u003cstrong\u003emedical devices\u003c\/strong\u003e and is compliant with the \u003cstrong\u003eMedical Devices Regulation (MDR) (EU) 2017\/745\u003c\/strong\u003e. All documents are fully customisable for your specific product.\u003c\/p\u003e\n\n\u003ch3\u003eWhat's included?\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLegal framework\u003c\/strong\u003e – basic document based on CE legislation (Word)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRisk analysis\u003c\/strong\u003e – pre-filled template with requirements from MDR (EU) 2017\/745 (Excel)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eInstructions for use\u003c\/strong\u003e – guidance document: what must be included in a user manual?\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eConformity assessment\u003c\/strong\u003e – flowchart: self-certification or is a Notified Body required? (Word)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCE label\u003c\/strong\u003e – guidance on CE marking requirements for medical devices\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDeclaration of Conformity (DoC)\u003c\/strong\u003e – editable model declaration (Word)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eHow it works\u003c\/h3\u003e\n\u003cp\u003eAll editable documents are fully customisable for your specific medical device. The conformity assessment flowchart helps you determine whether you need to involve a Notified Body.\u003c\/p\u003e\n\n\u003ch3\u003eNeed support?\u003c\/h3\u003e\n\u003cp\u003eWe have years of experience preparing CE technical files for medical devices and can assist you in completing your documentation. Please contact us for more information.\u003c\/p\u003e","brand":"Euronorm Advies B.V.","offers":[{"title":"Default Title","offer_id":53059199402312,"sku":null,"price":129.95,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0926\/1180\/5512\/files\/medical_devices_directive_template_technical_file_for_ce-marking.jpg?v=1779273749","url":"https:\/\/www.euronorm.net\/en\/products\/technical-file-for-medical-devices","provider":"Euronorm Advies","version":"1.0","type":"link"}