EU MDR Economic Operator & EU Authorized Representative

EU MDR Economic Operators Are Considered As 

• Manufacturer
• Authorized representative
• Importer
• Distributor
• As per article 22 (1) the entity that combines the devices which are CE Certified
• Devices that bear the CE marking
• IVD medical devices bearing CE marking (EU IVDR 2017/746)
• Compliant products used within a Medical Procedure or which presence on the pack is justified.

If anyone performs the above activities and they are not a legal manufacturer then such entity is also called an Economic operator. As per article 22 (3) an entity that sterilizes systems or procedure packs with the purpose of placing them on the market such entity also considers an Economic Operator.

After identification and addition of two points, we will consider economic operator-

• Manufacturer
• Authorised representative
• Importer
• Distributor
• Device combinatory
• Sterilizer company

In EU MDR 2017/745 and EU IVDR 2017/746 the Activities of the Economic Operator Are Defined in the Article

Article 11- Authorised representative

Article 13- General obligations for Importer

Article 14- General obligations for Distributor

What is EU Authorized Representative? 

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’s behalf concerning specified tasks given in MDR 2017/745. 

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 regulatory process of European countries, As a CE mark medical device consultant  we will help you in the process of making technical files for your product. If you want any regulatory guidance do contact us or you can also whatsapp us your details we will connect you back. 

The EU Authorized representative is also called CEREP, EUAR, EU REP, EC REP and EAR. 

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 representativ 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. 

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 member state upon request.  

EU Authorized Representative Responsibilities: 

The following tasks/ responsibilities are clearly defined in the mandate and the same require to be performed by the European Authorized Representative. 

• EU Authorized representative 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. 
• 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 year and for implantable devices documents are maintained for 15 years after the last device supplied by manufacturer in market. 
• 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) 
• If the Component authority of member state requested the Set of Technical documentation, then Authorized representative is responsible to provide the necessary documents to demonstrate the conformity of devices, in official union language determined by member state. 
• 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. 
• 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.) 
• The European Authorized representative may terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation. 

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. 

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. 

Obligations of Authorized Representative

•  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;
• A copy of the technical documentation  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);
• As  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
• 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;
• 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;
• 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;
•  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;
• If the manufacturer acts contrary to its obligations under this Regulation Terminate the mandate.

Why Do You Need a European Authorized Representative for Medical Devices?  

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: 

• The authorized representative authorizes the non-EU company to use their address on the packaging (which is mandatory) 
• The authorized representative holds the technical file, test report, and other relevant compliance documents 
• The authorized representative communicates with the national authorities (e.g. market surveillance authorities) on behalf of the non-EU company 

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: 

• Business registration documents 
• Product liability insurance 
• Compliance documents (e.g. test reports) 

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. 

Obligations of Importer as per the Article:

• The device need to be  CE marked and that the EU declaration of conformity of the device has been drawn up;
• A manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;
• According to this regulations and accompanied by the required instruction the device should be  labelled for us ;
• A UDI has been assigned by the manufacturer in accordance with Article 27.

Obligations of Distributor as per the article

•  According to article 10(11) The device is accompanied by the information to be supplied by the manufacturer
•  The importer has complied with the requirements set out in Article 13(3) for the imported devices.
• UDI has been assigned by the manufacturer wherever it is applicable.

Control on Economic Operator as per MDR

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 receives from the market, then the competent authority will come into the picture. 

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.  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. 

Operon Strategist’s Path to Seamless CE Marking

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’ needs and give error-free delivery. Our work methodology makes us leading medical device consulting company who provides end to end solutions to the manufacturer. Operon Strategist is a medical device regulatory  consulting company who works in co-ordination  with different regulatory bodies to provide  the regulatory services to clients.  we help the manufacturers in obtaining CE marking medical devices.