EU MDR Economic Operator

EU MDR Economic operators are considered as  

• Manufacturer 
• Authorised representative  
• Importer 
• Distributor 

As per article 22 (1) the entity that combines the devices which are CE Certified and  

• Devices that bear the CE marking 
• IVDmedical 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 
• Steriliser company 

Also read:

• Effects of COVID-19 on EU Medical Device Regulation
• Does Medical Device Regulation apply only to big companies? (EU MDR)
• Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
• Medical Device Registration in Australia
• Roles of PRRC

In EU MDR 2017/745 and EU IVDR 2017/746 the activities of Economic Operator are defined in the article  

Article 11- Authorised representative  

Article 13- General obligations for Importer 

Article 14- General obligations for Distributor 

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 authorised 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. 

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 制造商指定的制造er; 
• 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

如果你是一个制造商的公告机构nd 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 an importer or a distributor then the competent authority is responsible to have control over you. If you involve 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.  

The competent authority has a right to check that you are complying with the regulation MDR 2017/745, but there is no defined frequency for that. Usually, Competent authorities come to visit you only when they suspect a problem. 

Eg. If you are a Distributor and you are responsible for maintaining the defined storage conditions of medical devices as defined by manufacturer, but unfortunately, users found some issue/ device is not working as intended, then they can suspect that this comes from you and will come to visit at your premises. The Procedure Pack producer or Sterilizer are also considered as Economic Operators and all this is applicable to them also . 

To conclude the topic and to understand the EU MDR economic operator we can say that ,the objective of these operator is to maintain safety and performance of the medical devices in Europe .We are the leading188金宝慱亚洲体育公司provideend to end solutions to the manufacturer.