Responsibilities of Economic Operators as per MDR 745/2017

Responsibilities of Economic Operators as per MDR 745/2017

Posted By: | 20-06-2019 |

MDR describes four Economic Operators as below;

  1. Manufacturer 
  2. Authorized Representative 
  3. Importers 
  4. Distributors 

Manufacturer :

Manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under    its name or trademark.

Responsibilities of Manufacturer:

  • Responsible for design and manufacturing
  • Maintaining Quality Management System
  • Risk Management 
  • Clinical Evaluation including PMS and PMCF
  • To implement Vigilance procedures
  • Document all of the above
  • Cooperate with the authorities 
  • Appoint and Coordinate with Authorized Representative, Importers and Distributors. 

Authorized Representative:

‘Authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.

  • Where the manufacturer of a device is not established in  a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
  • The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.

Responsibilities of Authorized Representative:

  • The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request. 
  • To verify 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; 
  • Keep available 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; 
  • Comply with 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 L 117/25 Official Journal of the European Union EN.
  • In response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device
  •  Forward to the manufacturer any request by a competent authority of the Member State 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;
  • 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; 
  • Terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.

Importers

‘Importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;

Responsibilities of Importer:

  • Importers shall place on the Union market only devices that are in conformity with this Regulation.
  • In order to place a device on the market, importers shall verify that: 
  • the device has been 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; 
  • the device is labelled in accordance with this Regulation and accompanied by the required instructions for use; 
  • where applicable, a UDI has been assigned by the manufacturer
  • here an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. 
  • Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.
  • Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer. 
  • Importers shall verify that the device is registered in the electronic system in accordance with Article 29. Importers shall add their details to the registration in accordance with Article 31. 
  • Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance.
  • Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints. 
  • Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative. Importers shall co-operate with the manufacturer, the manufacturer's authorised representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 56 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken. 
  • Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative. 
  • Importers shall keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements.
  • Importers shall cooperate with competent authorities.

Distributor:

‘Distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service

Responsibilities of Distributor:

  • When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable. 
  • Before making a device available on the market, distributors shall verify that all of the following requirements are met: 
  • the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
  • the device is accompanied by the information to be supplied by the manufacturer 
  • for imported devices, the importer has complied with the requirements 
  • that, where applicable, a UDI has been assigned by the manufacturer
  • Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer. 
  • Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken.
  • Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request. 
  • Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.