The Role of Economic Operators within the EU MDR 2017/745

Who are Economic Operators according to EU MDR?

The term Economic Operators is explained in article 2 of EU MDR and IVDR and it refers to manufacturers, authorised representative, distributors and importers.

Specifically:

“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.

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

“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.’

“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.

Under the EU MDR and IVDR, Economic Operators share the responsibilities of ensuring compliance. The requirements are intended to ensure that different controls are carried out throughout the process of placing a device on the market, with each entity serving as a control on the others.

What are the responsibilities for Importers according to EU MDR?

Importers of medical devices have new responsibilities to meet specific regulatory requirements and verify certain information from the related manufacturers.

They need to ensure that device has been CE marked, labelling of the device in accordance with EU MDR requirements, and that UDI is assigned to the device.

Importers must ensure to take to take appropriate corrective actions when a non-conformance is identified and they must be engaged with post-market surveillance.

Finally, importers need to ensure that the device is registered and that while the device is under their responsibilities, storage or transport conditions do not compromise the compliance with the general safety and performance requirements.

From PMS point of view, importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals and provide to the manufacturers all the relevant information they need.

What are the responsibilities for distributors according to EU MDR?

The requirements for the distributors are reported in the Article 14 of EU MDR 2017/745. Specifically, before placing the device on the market, the distributor shall:

• ensure that the device brings the CE marking
• the device is provided with information from the manufacturers (IFU)
• if the device is imported, the importer shall comply with all the applicable requirements (see section before).
• UDI has been applied to the device.

If any of these requirements cannot be verified, the distributors shall not take the responsibilities to distribute the device on the market.

Storage and transportation are under the responsibilities of the distributor that shall ensure that these operations are performed under controlled conditions in order to avoid any impact on the device.

In case any complaints is received by the distributor, it should be forwarded immediately to the manufacturer.

Upon requests, all the documentation related to the device shall be made available to competent authorities.

What are the responsibilities for Authorised Representative according to EU MDR?

Finally, EU Authorised representative can place on the market medical devices in case the manufacturer is not established in one of the member states.

A written agreement shall be signed between the manufacturer and the authorised representative.

The authorised representative has different obligations, which are described in Article 11 of EU MDR. Some of these obligations are:

• verification of declaration of conformity and technical documentation and ensure they are available for any competent authorities
• 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
• immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users

Quality Agreement

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