{"product_id":"technisch-dossier-voor-medische-hulpmiddelen","title":"Technical CE Dossier Medical Devices – MDR (EU) 2017\/745 | Editable Template","description":"\u003ch2\u003eTechnical CE Dossier for Medical Devices\u003c\/h2\u003e\n\u003cp\u003eThis editable CE dossier has been specifically developed for manufacturers of \u003cstrong\u003emedical devices\u003c\/strong\u003e and complies with the \u003cstrong\u003eMedical Devices Regulation (MDR) (EU) 2017\/745\u003c\/strong\u003e. The dossier contains all the documents you need to document your medical device for CE conformity.\u003c\/p\u003e\n\n\u003ch3\u003eContents of the CE dossier\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eLegal framework (umbrella document)\u003c\/li\u003e\n\u003cli\u003eRisk analysis according to MDR (EU) 2017\/745\u003c\/li\u003e\n\u003cli\u003eMinimum requirements for the instructions for use\u003c\/li\u003e\n\u003cli\u003eNotified Body: when is intervention required?\u003c\/li\u003e\n\u003cli\u003eRequirements for the CE label\u003c\/li\u003e\n\u003cli\u003eEU Declaration of Conformity (editable template)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eChoose your option\u003c\/h3\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eCE dossier only\u003c\/strong\u003e – the complete editable template (€129.95)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCE dossier + online course\u003c\/strong\u003e – including video explanation on how to complete the dossier, optional final test and certificate (€325,-)\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003ch3\u003eNeed support?\u003c\/h3\u003e\n\u003cp\u003eWe have years of experience in preparing CE dossiers for medical devices and can guide you through the completion and finalization process. Please contact us using the form below.\u003c\/p\u003e","brand":"Euronorm Advies B.V.","offers":[{"title":"CE-file medical devices","offer_id":53059199467848,"sku":null,"price":129.95,"currency_code":"EUR","in_stock":true},{"title":"CE-file + online course","offer_id":53059199500616,"sku":null,"price":325.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0926\/1180\/5512\/files\/medische_hulpmiddelen_template_technisch_dossier_ce-markering.jpg?v=1779273714","url":"https:\/\/www.euronorm.net\/en\/products\/technisch-dossier-voor-medische-hulpmiddelen","provider":"Euronorm Advies","version":"1.0","type":"link"}