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 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?
Under the EU MDR 2017/745, an Authorised Representative (AR) plays a critical role for non-EU manufacturers in ensuring compliance with European regulatory requirements. The responsibilities of the Authorised Representative are defined primarily in Article 11 of the EU MDR. Here are the key responsibilities:
1. Verification of Compliance (Article 11.3):
The AR must ensure that:
- The EU Declaration of Conformity (DoC) and technical documentation are drawn up and kept up to date.
- The manufacturer has performed appropriate conformity assessment procedures.
- A copy of the technical documentation is available upon request by competent authorities.
2. Registration and Documentation (Article 11.4):
The Authorised Representative is responsible for:
- Registering the device in the EUDAMED database.
- Keeping a copy of the EU Declaration of Conformity, technical documentation, certificates, and any amendments or supplements available for at least 10 years (or 15 years for implantable devices) after the last device has been placed on the market.
3. Communication with Authorities (Article 11.3):
- Act as the primary point of contact for EU competent authorities and Notified Bodies.
- Cooperate with the authorities on preventive or corrective actions taken to eliminate or mitigate risks posed by the device.
4. Incident and Field Safety Corrective Actions (Article 11.5):
- Inform the manufacturer of complaints and reports of incidents.
- Coordinate with the manufacturer on the implementation of corrective actions, such as recalls or field safety corrective actions (FSCA).
5. Labelling Requirements (Article 11.3):
- The AR’s name, registered trade name, registered trademark, and address must appear on the device’s label, outer packaging, or instructions for use (IFU).
- This information must be clearly visible, legible, and permanent.
6. Document Retention (Article 11.4):
- Ensure availability of documentation for market surveillance and regulatory compliance.
- Maintain records of non-compliant devices, complaints, and corrective actions.
7. Market Surveillance (Article 11.3):
- Assist the manufacturer in complying with their obligations for market surveillance.
- Support the manufacturer’s obligations for post-market surveillance (PMS) and vigilance reporting.
8. Termination of Mandate (Article 11.6):
- If the mandate is terminated, the AR must:
- Notify the competent authority of the end of the mandate.
- Continue to maintain the technical documentation and required records for the necessary retention period.
9. Liability (Article 11.5):
- The AR may be held jointly and severally liable along with the manufacturer for defective devices under Directive 85/374/EEC.
10. Additional Responsibilities:
- Ensure the manufacturer has assigned a person responsible for regulatory compliance (PRRC) as required by Article 15 of the EU MDR.
- Monitor the manufacturer’s obligations, including UDI requirements and labeling compliance.
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