In the context of the EU medical device regulation (EU MDR), what is an “economic operator” and why is it important for medical device manufacturers to understand the roles of economic operators? What is the difference between “placing on the market” and “making available on the market,” and why is that important?
The term “economic operators” is defined in EU MDR 2017/745 as “a manufacturer, an authorized representative, an importer, a distributor or a person” that is part of the product supply chain. This includes, for example, manufacturers, importers, distributors, and warehousing facilities. The regulation describes the responsibilities of the many integral entities to bring a medical device to market in a compliant manner as well as their responsibilities once the device is on the market.
Answers to the following questions can help clarify the various roles and responsibilities of the economic operators:
- How do these economic operators need to interact with a European Commission (EC) representative, competent authorities, and notified bodies, according to the EU MDR?
- What is the impact if the manufacturer resides inside or outside the European Union?
- What are the requirements for importers and distributors?
- Can an importer and a distributor be the same entity for a given medical device?
At the virtual RAPS Euro Convergence Conference in May, two speakers discussed Economic Operators in light of the then-upcoming date of application for EU MDR on May 26. The speakers on the topic were:
- Medical Device Safety Service (MDSS) GmbH President Ludger J. Moeller (Authorized Representative, or AR)
- NAMSA Medical Writer Richard Bassett (Contract Research Organization, or CRO)
The speakers provided varied perspectives from an AR, CRO, and notified body toward addressing the requirements for economic operators.
Authorized Representative Perspective
Moeller debunked myths about economic operators. He began by clarifying the definition of a “manufacturer” as it relates inside and outside the European Union.
As shown in Figure 1, the key criteria to establish the entity that is the manufacturer is the one who fulfills the definition of “placing on the market.” “Placing on the market” according to EU MDR means the first making available of a device, other than an investigational device, on the EU market.
A manufacturer outside of the European Union would not be the manufacturer as it is not that particular company placing the device on the market, but, rather, the importer in the European Union that meets this criterion.
He indicated from his discussions with insurance companies in his role as an AR that “insurance companies view the importer as being very critical because according to the European regulation on liability the importer is actually the one that is liable.” Moeller further stated that “the liability regulation in the European Union has not changed as a result of EU MDR.” Conversely, a manufacturer existing in the European Union would fulfill the criterion of “placing on the market.”
Can an importer and a distributor be the same entity? Moeller’s answer is “no.” He made a clear distinction between an importer and distributor as noted in EU MDR. A distributor is any natural or legal person in the supply chain, other than the manufacturer or importer, that makes a device available on the market, up until the point of putting it into service. The basic difference in the roles is between “placing on the market” (importer) and “making available on the market” (distributor). To be clear, however, an importer could distribute product to an end user.
In Figure 2, there is a reference to Article 10 of EU MDR—General obligation of the Manufacturer— and Annex III. Both stipulate the communication expectation of the manufacturer with the economic operators from a quality management system (QMS) and post-market surveillance perspective, respectively.
Moeller indicated that “it may make sense” to establish contract agreements among economic operators, such as between Manufacturer-Importer, Manufacturer-Distributor, or Importer-Distributor. But it is not a requirement of the EU MDR.
The important expectation is the communication of nonconformities or device-related issues among economic operators with notified bodies and competent authorities. A contract agreement is a legally binding arrangement between the entities involved. This would assist in formalizing the relationship among the economic operators. These contract agreements are subject to review by a regulatory authority.
Figure 3 outlines product flow for the following three areas:
- Informing authorities on noncompliance issues
- Informing authorities on serious risks due to a noncompliance issue
- Informing authorities on vigilance interactions
Figure 3 also displays the necessary interactions for a company existing outside of the European Union to be notified of, as well as its communication pathways to the appropriate authorities within the European Union.
Moeller stated that a manufacturer “may receive multiple communications of one product failure” given the requirements. He did explain that Figure 3 does not provide all the communication pathways that might need to be executed but rather, only the “most important ones.”
The complexity of the necessary communications among economic operators is displayed in Figure 3. The interrelationship of the economic operators highlights the impact of EU MDR to generate awareness of non-compliant issues so the appropriate steps and corrective actions can be enacted.
[Related: Find out what two GMP experts think about the impact of the EU MDR on combination products. Click here to access a FREE report.]
Perspective on Impact to Manufacturer
Bassett described what the impact of MDR/IVDR requirements for economic operators means for manufacturers. He opened his presentation by explaining that manufacturers do not need to ensure the various economic operators are compliant with EU MDR (Figure 4). He stated that “this is not a compliance issue and you will not be checked as a part of your conformity assessment.”
While an importer or distributor would not be in scope for a conformity assessment audit, he said that what falls under the scope of an audit are “the requirements in regard to the procedures, policies, and contracts they have set up for themselves” as part of their QMS. As per ISO 13485, the entities that are a part of the distribution of a medical device could be subject to an audit.
Bassett explained that a manufacturer may incorporate another manufacturer`s device, e.g., as part of a test kit or procedure pack. As a result, the manufacturer would be making the device available to the market (distributor role) or placing it on the market in the European Union (importer role). Figure 5 outlines some of the requirements if a manufacturer becomes an importer or distributor. As their role would be changing from a regulatory perspective, they would need to adhere to certain requirements as indicated by being a distributor or importer.
In summary, it is important to understand the relationship of economic operators with their role in moving devices through the supply chain. Requirements will change as a function of a company’s role in making devices available to the market. Understanding the reporting requirements for economic operators to the appropriate regulatory authorities will be paramount given the attention to post-market surveillance as described in EU MDR.
[Editor’s note: For more from Mark Agostino on the EU MDR, read his article, “Navigating a Regulatory Path to Market Through EU MDR Article 117.”]
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