Consolidating Authorized Representative and Importer Roles Pros and Cons

In this article, we share the advantages and disadvantages associated with consolidating the roles of authorized representative and importer. Importers and authorized representatives are among the economic operators defined in the MDR/IVDR, each with their respective obligations established in the regulations.  While many non-EU manufacturers opt to maintain separate importers and authorized representatives, others have chosen to have a single entity take on both roles. Here are several pros and cons in having these roles consolidated with a single entity.

Pros of consolidating Authorized Representative and Importer roles

By leveraging the regulatory experience of authorized representatives, who now bear increased liabilities under the MDR/IVDR, the consolidated entity gains a deeper understanding of regulatory requirements. Additionally, having a single entity as importer/authorized representative allows for efficient communication and consolidation of regulatory activities, ensuring conformity with obligations such as reporting non-conformities and handling complaints. This consolidation also minimizes the impact on labeling space, as both the importer and authorized representative information can be included on the device labels, optimizing limited space.

In this section, we will delve deeper into the advantages of consolidating the roles of authorized representative and importer.

Leveraging authorized representative regulatory experience

The obligations and subsequent regulatory burden on authorized rep have increased under the MDR/IVDR when compared to the MDD/IVDD. This includes that they are now legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. While the obligations of authorized representatives are more onerous under the regulations, in contrast to importers, they were already accustomed to having obligations under the MDD/IVDD.

Additionally, under the MDR/IVDR only the manufacturer and authorized representative must have access to a person responsible for regulatory compliance (PRRC). With a single entity as importer/authorized representative, the importer would have direct access to the PRRC to serve as an additional resource for internal compliance oversight. 

Therefore, consolidating these roles with a single entity would result in an entity with greater experience and familiarity with regulatory requirements than an importer alone. 

Regulatory activity/responsibility consolidation

Another pro is the consolidation of regulatory activities/responsibilities, particularly as it relates to communication between economic operators. There are several importer/distributor obligations to communicate certain information to the authorized rep, including: 

• • Non-conformity of devices with the regulation (prior to and after placing devices on the market) 

• • Complaint details, including recalls and withdrawals 

Having a single entity as importer/authorized representative would ensure conformity with these requirements through internal communication. 

In this scenario, importers would also be required to verify that the manufacturer or authorized representative has been registered in EUDAMED within two weeks of placing a device on the market.

Furthermore, as the importer/authorized representative would have access to a PRRC, the PRRC would be able to directly have access to product / information allowing them to fulfill their responsibilities under the regulations (particularly critical for responsibilities directly linked to verification of device conformity). 

Minimization of impact to labeling space

Under the regulations both the name and address of both the importer and authorized representative must be indicate on device labeling (permissible locations can vary). Manufacturers that include this information on device labels, particularly those that are limited by the available label space, minimize the amount of labeling space for this information by having a single entity as importer/authorized representative.

Cons of consolidating Authorized Representative and Importer roles

In the subsequent section, we will delve deeper into the potential drawbacks of consolidating the roles of authorized representative and importer.

Increased regulatory risk under a single entity

Under this scenario there is a risk that where instances of regulatory non-conformity are observed, there may be non-conformity against both importer and authorized representative obligations. This con could be addressed to some extent by ensuring that manufacturer supplier controls are adequately robust when qualifying the importer/authorized representative for service provision. 

Change management

If a need arises for the manufacturer to assign either role to another entity, the current importer/authorized representative may not willingly cooperate in the transition. Transparent provisions in service agreements could address this con by outlining the roles and responsibilities during such transitions.

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