EU Regulatory Importer: Legal Liabilities & Considerations

Manufacturers of Medical Devices and In Vitro Diagnostics (IVDs) located outside the European Union (EU) are required to appoint an Authorized Representative (AR) and Regulatory Importer within the EU. While the Regulatory Importer and Authorized Representative can be different entities, it is advantageous for manufacturers to consider a neutral third-party firm for these crucial roles. This article explores the significance of selecting the right Authorized Representative and Regulatory Importer, delving into their legal liabilities and providing essential considerations for manufacturers.

The role of an Authorized Representative

Understanding the legal liabilities of an Authorized Representative is crucial for manufacturers evaluating their current representative or seeking a new one.

Key considerations

1. Protocols to maintain Technical Records, updates, verify the conformity assessment route selected? 

2. Expertise in verifying if the Registration of the device is done as per Articles 27 (UDI), Article 29 (Registration of Device) and Article 31 (Registration of Economic Operators)?  

3. Person Responsible for Regulatory Compliance (PRRC) in their organization? 

4. Procedure to handle vigilance reported by professionals, users, different levels of the supply chain as the AR is identified on the label, package and IFU? 

5. Infrastructure to handle a possible audit by the Notified Bodies? 

6. Experience in handling the nuances of updates due to change in regulation from MDD to MDR?

Mandatory “yes” to these questions aligns with legal liabilities as defined in Article 2(32) MDR and Article 2(25) IVDR. Article 11 of MDR/IVDR further outlines general roles and responsibilities.

MDR/IVDR Article 11 defines the general roles and responsibilities of an Authorized Representative, emphasizing their legal liability for documentation maintenance, device updates, liaising with authorities, and handling post-market requirements. Manufacturers must choose an AR with a robust infrastructure capable of efficiently managing queries from various supply chain levels and ensuring prompt communication with both manufacturers and authorities.

The distinct role of a Regulatory Importer

Legal liabilities for a Regulatory Importer, as per MDR Article 2(33) and IVDR Article 2(26), involve placing devices from a third country into the EU. While Article 13 outlines Regulatory Importer obligations, the primary focus lies on labeling and EUDAMED registrations. Key Regulatory Importer responsibilities include ensuring device registration, UDI compliance, proper labeling, and monitoring complaints and recalls.

Legal liabilities: Regulatory Importer vs Authorized Representative

The legal liability of a Regulatory Importer is different from that of an Authorized Representative.

Key responsibilities of a Regulatory Importer:

1. As per Article 2(33) MDR and Article 2(26) IVDR, a Regulatory Importer is a person/ legal entity established within the EU and places the device from a third country into the EU.  

2. While Article 13 describes in detail the obligations of a Regulatory Importer, the primary focus is on labeling and EUDAMED Registrations.

3. A Regulatory Importer is legally liable to ensure that the medical devices and IVDs they place in the market are registered on the EUDAMED platform, have UDI, and meet labeling requirements. Additionally, Regulatory Importers must keep a track of complaints, recalls etc. 

4. As per Article 13, the Regulatory Importer must be identified on the packaging till the point where the product is put in use. While this allows manufacturers to have multiple regulatory importers, from a practical viewpoint it would be challenging to handle multiple distributor names as well as regulatory importers on labels and/or inserts.  

In this article, we outline additional pros and cons of consolidating the roles of your Authorized Representative and Regulatory Importer.

Understanding the role of the Authorized Representative post-Notified Body approval

In the case of Self Certified Products, the legal liability is even bigger as there is no Notified Body Approval process involved. Hence the entire compliance responsibility falls on the Authorized Representative. MedEnvoy does the detailed due diligence to assist Class I self-certified manufacturers to understand the gaps in their documentation and help close these bottlenecks for maintaining compliance with the local requirements.  

In the case of devices going through Notified Body Approval: even though the documents are audited by a Notified Body in the case of Notified devices, the Authorized Representative is still responsible to confirm that the proper conformity assessment procedure is followed, technical documents are compliant, and the Declaration of Conformity is correct.   

Choosing between Distributors and independent companies for legal liabilities

Selecting an Authorized Representative is important not only from a compliance point of view but also from a business point of view. While there can be multiple Regulatory Importers for each specific generic device group, there can be only one authorized representative for the same. This Representative is the “manufacturer” in the eyes of the local authorities. A formal written document is required to appoint the Authorized Representative and this entity must be declared to the notified body to get approval in the CE certification.  

Given the mandate by the European Law for Authorized Representative and Regulatory Importer for medical devices, it is important to select the right one. If the manufacturer wishes to change the Authorized Representative, while it is a simple enough process to do so (explained in Article 13), it is an expensive one. All labels, art works, IFUs, marketing materials etc. will have to be updated with the name of the new Authorized Representative. Additionally, proper documentation to show the flow from the old Authorized Representative to the new one, transfer of complaints, post market information, no lapse of timeline must be attended to. 

Hence, to maintain independence, compliance and ensure continued availability of the device in the market, selection of an Independent Neutral Authorized Representative is important to the manufacturers business and financial planning.  This also helps in ensuring that compliances are followed, post market vigilance is promptly notified to the authorities as often conflict of interest may occur between the distributors interest in protecting the business side vs the compliance requirements for the same.  

MedEnvoy as your Regulatory Importer

MedEnvoy has been working with medical device and IVD manufacturers since 2005. We understand the Authorized Representative/Regulatory Importer requirements and compliance issues associated with the MDR and IVDR.  

Selecting an “independent” Regulatory Importer and Authorized Representative that is solely focused on executing on its Authorized Representative/Regulatory Importer obligations and that will ensure MDR compliance without a need to take physical possession of your devices, is an option MedEnvoy Global offers to non-EU based manufacturers as an alternative to selecting a distributor(s) as your importer. 

Avoid many issues by appointing a single Authorized Representative/Regulatory Importer: You can avoid many of the labeling and contract hassles associated with having multiple regulatory importers by appointing just one instead. One point of contact. One contract. One team responsible for your compliance. Contact us to learn more.  

MedEnvoy offers EU Authorized Representative and Regulatory Importer services

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