Your Gateway to the EU Market: The Role of the Authorised Representative

Your Gateway to the EU Market: The Crucial Role of the Authorised Representative

Friday, 07 November 2025

Your Gateway to the EU Market: The Role of the Authorised Representative | QbD Group

7:14

For medical and in vitro diagnostic device manufacturers based outside the European Union, accessing the vast EU market comes with a critical requirement: appointing an Authorised Representative (AR). This is not a mere administrative formality. Your AR is your trusted regulatory partner, the bridge between your company and the European competent authorities. Choosing the right AR can be the difference between smooth market access and costly delays.

This post explores the essential functions, responsibilities, and legal standing of an Authorised Representative under the EU's Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

What is an Authorised Representative?

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.

A manufacturer must designate a sole authorised representative for each "generic device group". This designation is only valid when accepted in writing by the AR. This formal mandate is the cornerstone of the relationship, clearly defining the tasks the AR will perform on the manufacturer's behalf.

But not all ARs are the same. While the regulations define the minimum responsibilities, a strong AR distinguishes itself through expertise and a solid quality framework. At QbD RepS BV, part of QbD Group, our ISO 13485 certification, wealth of regulatory knowledge, and well-established processes ensure reliable support and peace of mind for our clients.

Core Responsibilities: Where Expertise Matters Most

The mandate must, at a minimum, empower the AR to perform several key tasks. These responsibilities position the AR as a gatekeeper and a point of contact within the EU.

1. Verification and Documentation Management

The AR is responsible for verifying that the manufacturer has drawn up the EU declaration of conformity and technical documentation. They must also check that an appropriate conformity assessment procedure has been carried out by the manufacturer.

Crucially, the AR must keep a copy of the technical documentation, the declaration of conformity, and any relevant certificates permanently available for inspection by competent authorities. This documentation must be retained for at least 10 years after the last device has been placed on the market, or 15 years in the case of implantable devices.

2. Registration Obligations

The AR has its own registration obligations under the regulations and must submit its details to the EUDAMED database. It is also the AR's responsibility to verify that the manufacturer has complied with its registration obligations in EUDAMED.

3. Cooperation with Competent Authorities

The AR acts as the primary contact point for competent authorities within the EU. Their duties include:

Providing authorities with all necessary information and documentation to demonstrate a device's conformity.
Forwarding any request from a competent authority for device samples to the manufacturer and verifying that the authority receives them.
Cooperating with authorities on any preventive or corrective actions taken to mitigate risks posed by devices.

4. Vigilance and Complaint Handling

The AR plays a vital role in post-market surveillance. They must immediately inform the manufacturer about any complaints and reports received from healthcare professionals, patients, and users regarding suspected incidents related to a device for which they are designated.

5. Terminating the Mandate for Non-Compliance

If a manufacturer acts contrary to its obligations under the regulations, the mandate must empower the AR to terminate the agreement. In such cases, the AR is obligated to immediately inform the competent authority of the Member State where it is established, as well as the relevant Notified Body, of the termination and the reasons for it.

With QbD RepS BV, you gain a partner who ensures regulatory obligations are managed efficiently, facilitates clear communication with competent authorities, and applies deep expertise and well-established processes to support your success in the EU market.

The Weight of Responsibility: Legal Liability

One of the most significant aspects of the AR's role is the potential for legal liability. Article 11(5) of the MDR/IVDR states that if a non-EU manufacturer has not complied with its general obligations under Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.

This "joint and several" liability means that an injured party could seek compensation from the AR directly, just as they could from the manufacturer. This liability is conditional on the manufacturer having failed to meet its obligations. This underscores the importance for the AR to ensure their manufacturing partner is fully compliant, including having sufficient financial coverage for potential liability.

That’s why you need an AR who not only has the right expertise but also takes their legal responsibilities seriously. At QbD RepS BV, we acknowledge the weight of joint liability under the MDR and IVDR and ensure that robust compliance measures are in place from the outset—protecting both the manufacturer and ourselves.

Changing the Relationship

The regulations foresee the possibility of changing the AR. This process must be clearly defined in a tripartite agreement between the manufacturer, the outgoing AR, and the incoming AR. This agreement must address the transfer of documents and the handling of any complaints or incident reports received by the outgoing AR after the mandate has ended.

Our team has supported many manufacturers in transitioning from their previous Authorised Representative to QbD RepS BV, ensuring continuity throughout the process. If you have doubts about your current AR, QbD RepS BV can help you make the switch smoothly and with confidence.

In Conclusion

The role of the Authorised Representative is far more than a simple mailing address in the EU. It is a regulated function with substantial responsibilities and significant legal liability. The AR is an essential partner for non-EU manufacturers, acting as a regulatory liaison and trusted point of contact with authorities.

By partnering with QbD RepS BV, part of QbD Group, you benefit from:

Deep regulatory expertise across both MDR and IVDR.
Reliable Compliance support that goes beyond administrative tasks.
Well-established communication with EU competent authorities.
Access to the Global QbD network of regulatory, quality, and clinical experts.
Trust and accountability backed by a strong track record with leading manufacturers.

With QbD RepS BV, you don’t just get an EU address, you gain a trusted partner committed to helping you enter and thrive in the European market with confidence.

The potential benefits of this harmonization are significant: a single coordinated submission process, fewer administrative delays, and more consistent feedback. Until then, sponsors must navigate a fragmented regulatory landscape, but with the right support and preparation, it is absolutely manageable.

Contact us today and discover how QbD Group can accelerate your EU journey, while keeping you fully compliant every step of the way.

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