{"id":6349,"date":"2026-05-22T11:12:03","date_gmt":"2026-05-22T05:42:03","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6349"},"modified":"2026-05-22T11:12:03","modified_gmt":"2026-05-22T05:42:03","slug":"eu-mdr-economic-operator","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/br-en\/eu-mdr-economic-operator\/","title":{"rendered":"Understanding EU MDR Economic Operators and Authorized Representatives"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6349\" class=\"elementor elementor-6349\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-14f06221 e-flex e-con-boxed e-con e-parent\" data-id=\"14f06221\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7432fca elementor-widget elementor-widget-heading\" data-id=\"7432fca\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Understanding EU MDR Economic Operators and Authorized Representatives<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1cf3ce44 e-con-full e-flex e-con e-child\" data-id=\"1cf3ce44\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-452c9944 elementor-widget elementor-widget-text-editor\" data-id=\"452c9944\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">For the medical device manufacturer, it is important to understand the role of the EU MDR economic operator. These operators are also referred to with the acronym MAID. The role of an economic operator is tied to legal liability so one should understand how they fit in the economic operator framework.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e4d7c0e elementor-widget elementor-widget-heading\" data-id=\"e4d7c0e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Who Are EU MDR Economic Operators?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e8e9480 elementor-widget elementor-widget-text-editor\" data-id=\"e8e9480\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Economic operator As per MDR \/ IVDR economic operator means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Articles 22(1) and 22(3).\u202fThe entity which supplies goods, services in the context of that market is termed as operator.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1aa5815 elementor-widget elementor-widget-heading\" data-id=\"1aa5815\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">EU MDR Economic Operators Are Considered As\u202f<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-465af55 elementor-widget elementor-widget-text-editor\" data-id=\"465af55\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Manufacturer<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Authorized representative<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Importer<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Distributor<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">As per article 22 (1) the entity that combines the devices which are CE Certified<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Devices that bear the <a href=\"https:\/\/operonstrategist.com\/elevateplus\/ce-marking-eu-mdr-ivdr\/\">CE marking<\/a><\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><i><span style=\"font-weight: 400;\">IVD<\/span><\/i><span style=\"font-weight: 400;\"> medical devices bearing CE marking (EU IVDR 2017\/746)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Compliant products used within a Medical Procedure or which presence on the pack is justified.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">If anyone performs the above activities and they are not a legal manufacturer then such entity is also called an Economic operator.\u202fAs per article 22 (3) an entity that sterilizes systems or procedure packs with the purpose of placing them on the market such entity is also considered an Economic Operator.<\/span><\/p><p><span style=\"font-weight: 400;\">After identification and addition of two points, we will consider economic operator-<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Manufacturer<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Authorised representative<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Importer<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Distributor<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Device combinatory<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sterilizer company<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2905650 elementor-widget elementor-widget-heading\" data-id=\"2905650\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">In EU MDR 2017\/745 and EU IVDR 2017\/746 the Activities of the Economic Operator Are Defined in the Article:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4e991fd elementor-widget elementor-widget-text-editor\" data-id=\"4e991fd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li><span style=\"font-weight: 400;\">Article 11- Authorised representative<br \/><br \/><\/span><\/li><li><span style=\"font-weight: 400;\">Article 13- General obligations for Importer<br \/><br \/><\/span><\/li><li><span style=\"font-weight: 400;\">Article 14- General obligations for Distributor<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6f0967c elementor-widget elementor-widget-heading\" data-id=\"6f0967c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is an EU Authorized Representative?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6719db2 elementor-widget elementor-widget-text-editor\" data-id=\"6719db2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">EU Authorized Representative means any natural or legal person established within the Union who has obtained and accepted a written mandate from a manufacturer, located outside the European Union, to act on the manufacturer\u2019s behalf concerning specified tasks given in MDR 2017\/745.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">If the manufacturer is located outside the European Union or the manufacturer does not have a registered place of business in the European Union, in that case, the manufacturer may hire a representative from the European Union called an Authorized European Representative. Operon Strategist operates globally, our team knows the regulatory process of European countries. As a <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/ce-marking\/\"><span style=\"font-weight: 400;\">CE mark medical device consultant<\/span><\/a><span style=\"font-weight: 400;\"> we will help you in the process of making technical files for your product. If you want any regulatory guidance do <\/span><a href=\"https:\/\/operonstrategist.com\/contact-us\/\"><span style=\"font-weight: 400;\">contact us<\/span><\/a><span style=\"font-weight: 400;\"> or you can also <\/span><a href=\"https:\/\/api.whatsapp.com\/send\/?phone=919028043428&amp;text=Hi%2C+I+require+regulatory+consultancy+for+medical+device.&amp;app_absent=0\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">whatsapp us<\/span><\/a><span style=\"font-weight: 400;\"> your details we will connect you back.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">The EU Authorized representative is also called <strong>CEREP, EUAR, EU REP, EC REP and EAR<\/strong>.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Manufacturer and Authorized Representative must sign a Mandate\/ Agreement before initiating any activity. The mandate should in reality outline the roles and obligations of the both parties and the designation shall represent the authorized representative mandate, it will be valid only when established in writing through the authorized representative and will be effective at the least for all devices of the same regular device group.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">The EU authorized representative shall carry out the duties specified in the mandate agreed between it and the manufacturer. The authorized representative shall provide a copy of the mandate to the competent authorities of the member state upon request.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-31c15ee elementor-widget elementor-widget-heading\" data-id=\"31c15ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">EU Authorized Representative Responsibilities: <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8485373 elementor-widget elementor-widget-text-editor\" data-id=\"8485373\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The following tasks\/ responsibilities are clearly defined in the mandate and the same require to be performed by the European Authorized Representative.\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">EU Authorized representatives shall verify that the EU declaration of conformity, other technical documents and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">EU Authorized representative shall maintain a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with certificates of conformity, at the disposal of competent authorities for the period of 10 years and for implantable devices documents are maintained for 15 years after the last device supplied by manufacturer in market.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Comply with the registration obligations and verify that the manufacturer has complied with the registration obligations as per Article 27 (Unique device Identification) and Article 29 (Registration of Devices)\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">If the Component authority of a member state requested the Set of Technical documentation, then the Authorized representative is responsible to provide the necessary documents to demonstrate the conformity of devices, in official union language determined by member state.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Forward to the manufacturer any request by a competent authority of the Member State in which the authorized representative has its registered workplace of business for samples, or access to a device and affirm that the competent authority receives the samples or is given access to the device.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">EU Authorized representative shall cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not always viable mitigate the risks posed by devices; (immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.)\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The European Authorized representative may terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.\u00a0<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">If the European authorized representative terminates the Mandate, then they immediately need to notify the Competent Authority of the member state along with the reason for termination.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Where the manufacturer is not established in a Member State and has not complied with the obligations given in article 10 (General Obligations of Manufacturer), the EU authorized representative shall be legally liable for faulty devices on the same basis as, and jointly and severally with, the manufacturer. <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a4c9896 elementor-widget elementor-widget-heading\" data-id=\"a4c9896\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Obligations of Authorized Representative<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c8896e elementor-widget elementor-widget-text-editor\" data-id=\"0c8896e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">As per article 11, verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A copy of the technical documentation\u00a0 need to be available, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued as per the Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">As\u00a0 the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29; 5.5.2017 EN Official Journal of the European Union 117\/25<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A request from a competent authority, provide that the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Any request by a competent authority of the Member State forward to the manufacturer in which the authorized representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The manufacturer should get informed immediately about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">If the manufacturer acts contrary to its obligations under this Regulation, terminate the mandate.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c2d0ae elementor-widget elementor-widget-heading\" data-id=\"0c2d0ae\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why Do You Need a European Authorized Representative for Medical Devices?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e053cca elementor-widget elementor-widget-text-editor\" data-id=\"e053cca\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">As of July 2021, companies located outside the EU, but selling to consumers in the European Union, must have an authorized representative. The role of the authorized representative for medical devices can be summarized as follows:\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The authorized representative authorizes the non-EU company to use their address on the packaging (which is mandatory)\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The authorized representative holds the technical file, test report, and other relevant compliance documents\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The authorized representative communicates with the national authorities (e.g. market surveillance authorities) on behalf of the non-EU company\u00a0<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">There are a number of companies acting as European authorized representatives for medical devices as a paid service, some of which are listed in this article. These companies normally charge a yearly fee. That said, paying a fee alone is not sufficient, as you must also provide extensive documentation:\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Business registration documents\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Product liability insurance\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Compliance documents (e.g. test reports)\u00a0<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">In short, you need to have your act together before you can even appoint an authorized representative. Keep in mind that the customs authorities can, and will, confiscate and destroy inbound shipments without an authorized representative address.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-49d8051 elementor-widget elementor-widget-heading\" data-id=\"49d8051\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Obligations of Importer\u202fas per the Article:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-32280ce elementor-widget elementor-widget-text-editor\" data-id=\"32280ce\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The device need to be CE marked and that the EU declaration of conformity of the device has been drawn up;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A manufacturer is identified and that an authorised representative in accordance with\u202f<\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:02017R0745-20170505#tocId15\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Article 11<\/span><\/a><span style=\"font-weight: 400;\">\u202fhas been designated by the manufacturer;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">According to this regulations and accompanied by the required instruction the device should be\u00a0 labelled for us ;<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">A UDI has been assigned by the manufacturer in accordance with \u202f<\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:02017R0745-20170505#tocId32\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Article 27<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a80d5eb elementor-widget elementor-widget-heading\" data-id=\"a80d5eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Obligations of Distributor\u202fas per the article:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1802676 elementor-widget elementor-widget-text-editor\" data-id=\"1802676\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">According to article 10(11) The device is accompanied by the information to be supplied by the manufacturer<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The importer has complied with the requirements set out in Article 13(3) for the imported devices.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">UDI has been assigned by the manufacturer wherever it is applicable.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-90b7b21 elementor-widget elementor-widget-heading\" data-id=\"90b7b21\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Control on Economic Operator as per MDR<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-50f1b84 elementor-widget elementor-widget-text-editor\" data-id=\"50f1b84\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">If you are a manufacturer then the notified body and competent authority have direct control over you. The Notified Body will audit you every year and if any severe complaint or a series of non-severe complaints received from the market, then the competent authority will come into the picture.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">If you are an Authorized representative of an importer or a distributor then the competent authority is responsible for having control over you. If you are involved in any activity like storage and or distribution of devices and receive any complaint from the market then the economic operator shall be audited by the notified body of the manufacturer.\u202f But some notified bodies will audit you every year to check your performance as per regulation MDR 2017\/745. If required they can perform an unannounced audit.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-70cfaac elementor-widget elementor-widget-heading\" data-id=\"70cfaac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Operon Strategist's Path to Seamless CE Marking<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a90b1c8 elementor-widget elementor-widget-text-editor\" data-id=\"a90b1c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The objective of these operators is to maintain safety and performance of the medical devices in Europe. We always work hard, do keen research on clients\u2019 needs and give error-free delivery. Our work methodology makes us a leading <\/span><a href=\"https:\/\/operonstrategist.com\/\"><span style=\"font-weight: 400;\">medical device consulting<\/span><\/a><span style=\"font-weight: 400;\"> company who provides end to end solutions to the manufacturer. Operon Strategist is a medical device regulatory consulting company who works in co-ordination\u00a0 with different regulatory bodies to provide\u00a0 the regulatory services to clients. We help the manufacturers in obtaining <\/span><a href=\"https:\/\/operonstrategist.com\/sa-en\/ce-certification-for-medical-devices\/\"><span style=\"font-weight: 400;\">CE marking medical devices<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\t\t\t\t\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\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>For the medical device manufacturer, it is important to understand the role of the EU MDR economic operator. These operators are also referred to with the acronym MAID. The role of an economic operator is tied to legal liability so one should understand how they fit in the economic operator framework. Who Are EU MDR [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6517,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6349","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/posts\/6349","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/comments?post=6349"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/posts\/6349\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/media\/6517"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/media?parent=6349"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/categories?post=6349"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/tags?post=6349"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}