Authorised Representative For Non-EU Manufacturers

Sebastian Skorka • Uncategorized • Updated May 31, 2025

As a manufacturer based outside the European Union (EU) and without an EU subsidiary, you must appoint an Authorised Representative (AR) to market your medical device in the EU. The AR acts on your behalf to ensure compliance with EU regulations, manage communications with regulatory bodies, and provide access to necessary documentation. In this article, we will outline the responsibilities of an AR and propose an alternative option for non-EU manufacturers, which is setting up a subsidiary in the EU to handle the certification process directly.

Regulatory Background and Definitions

The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) outline specific roles for economic operators in the medical device market. In addition to manufacturers and distributors, the AR plays a crucial role. According to MDR Article 2(32) and IVDR Article 2(25), an authorised representative is defined as:

"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 under this Regulation."

Core Responsibilities of an Authorised Representative (AR):

Outlined in Article 11 of both MDR and IVDR, the responsibilities include:

Article 11	Comments
(a) verify that the EU declaration of conformity and technical documentation have been drawn up	Is the Declaration of Conformity signed? Did the manufacturer create the appropriate technical documents and tests?
(b) keep available a copy of the technical documentation, the EU declaration of conformity	This includes a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market, and in the case of implantable devices, a period of at least 15 years after the last device has been placed on the market.
(c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;	Register as an AR in EUDAMED.Did the manufacturer assign the UDI and is registered in EUDAMED together with the medical device?In addition to registration, the authorised representative must verify that:its own registered information is updated within one week of any change occurring (MDR Article 31(4)/IVDR Article 28(4))the accuracy of the data it has submitted at intervals defined in Article 31(5) MDR/Article 28(5) IVDR, namely not later than one year after initial submission of the information, and every second year thereafter.
(d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;	Collaborate with the regulatory bodies when needed.
(e) 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 for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;	N/A
(f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;	N/A
(g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;	Forward complaints to the manufacturer about incidents and complaints. Communicate major incidents to the competent authorities if necessary.
(h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.	N/A

Liability of the Authorised Representative

The AR assumes joint and several liability for defective devices under certain conditions, as specified in Article 11(5) MDR/IVDR. If the manufacturer fails to meet obligations under Article 10, the AR may be held liable, along with the manufacturer, for any damage caused by defective devices.

The AR is also encouraged to verify that the manufacturer has appropriate financial coverage, such as liability insurance, to mitigate risk in case of non-compliance.

The Role of the PRRC (Person Responsible for Regulatory Compliance)

According to Article 15(6) MDR, ARs must have at least one Person Responsible for Regulatory Compliance (PRRC) available at all times. The PRRC ensures that regulatory tasks, such as post-market surveillance (PMS) and compliance with safety regulations, are managed correctly. Importantly, the PRRC for the AR cannot be the same as the PRRC for the non-EU manufacturer.

Post-Market Surveillance and Documentation

The AR plays a role in post-market surveillance by forwarding complaints or reports received from users to the manufacturer. In some cases, the AR can take on additional responsibilities such as drafting the PMS plan and preparing Periodic Safety Update Reports (PSURs). Regulatory authorities have the right to request these documents from the AR at any time.

Alternative Approach: Establishing a Subsidiary in the EU

While appointing an AR is the traditional route for non-EU manufacturers, an alternative is to establish a subsidiary within the EU. This approach offers several key advantages:

Direct Control Over Certification and Compliance:
- By having a subsidiary in the EU, the manufacturer retains direct oversight of the certification process and regulatory compliance, reducing dependence on third parties like ARs.
Streamlined Communication:
- The subsidiary can communicate directly with regulatory bodies, including Notified Bodies and Competent Authorities, ensuring timely and accurate
Cost Efficiency:
- Although establishing a subsidiary entails upfront costs, it may prove more cost-effective in the long term by reducing AR fees and streamlining operations.
Flexibility and Integration:
- Having a physical presence in the EU allows for more integrated post-market surveillance, customer support, and compliance management, thus improving operational efficiency.

Summary

For non-EU manufacturers, appointing an Authorised Representative is a necessary step to ensure compliance with EU MDR and IVDR regulations. The AR has significant responsibilities, including verifying documentation, managing device registration, and liaising with regulatory bodies. The AR is also subject to liability risks if the manufacturer fails to meet their obligations.

Alternatively, non-EU manufacturers can establish an EU subsidiary, which allows for direct control over the certification process and better management of risks and costs. While this requires more investment, it offers greater flexibility and reduces reliance on third-party representatives.

In conclusion, while the AR is essential for non-EU manufacturers without a physical EU presence, setting up an EU subsidiary offers a viable and often more advantageous alternative for managing compliance and market access.

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