European Authorized Representative

If you are a medical device manufacturer established outside the European Union, appointing a European Authorized Representative (EAR) is a legal requirement. Sobel acts as your trusted EAR, supporting compliance with MDR obligations and providing a clear, structured interface with regulatory authorities

For who?

Sobel supports your entry and long-term presence in the European medical device market with clarity and confidence.

Why do you need this service?

Manufacturers established outside the EU cannot place medical devices on the European market without appointing a European Authorized Representative.

This role serves as the official point of contact with competent authorities, supporting communication, documentation availability, and regulatory follow-up.

A qualified Authorized Representative helps ensure that regulatory obligations are fulfilled consistently, in highly regulated European markets.

From legal requirements to regulatory confidence

A structured and reliable authorized representative helps reduce regulatory risk, ensures timely responses to authority requests, and supports long-term market access in Europe.

Partner with Sobel for clear, reliable, and confident access to the European medical device market.

Appointment and mandate

We manage the formal designation process to appoint Sobel as your European Authorized Representative, in accordance with Regulation (EU) 2017/745.

Regulatory liaison

We act as your official point of contact with European competent authorities, handling regulatory communications related to your medical devices and establishment.

Documentation availability and oversight

We ensure that required documentation, including the EU Declaration of Conformity and technical documentation, is available to competent authorities upon request, in line with MDR requirements.

Authority requests and cooperation

We coordinate responses to authority requests, and cooperate with competent authorities on preventive or corrective actions when required.

Regulatory continuity

We support mandate transitions in accordance with Article 13 of the EU MDR and help maintain regulatory continuity throughout the product lifecycle.

Related
Services

Appointing a European Authorized Representative is only one part of a broader European regulatory strategy. Authorities expect continuous oversight, documentation control, and post-market vigilance — areas where Sobel provides additional regulatory support, including:

Biological Evaluation (BEP, BER)

Expert biological evaluation services. BEP, BER, Gap analysis, and regulatory support.

CE Mark Regulatory Support

Gap analysis, technical documentation, and ongoing regulatory for CE Mark for Medical Devices.

Toxicological Risk Assessment (TRA)

TRA aligned with EU MDR and ISO 10993 series, supporting chemical safety evidence.

Authorized representation that supports confident market access

Appointing the right European Authorized Representative is a strategic decision that directly impacts regulatory risk, authority interactions, and market continuity. Sobel combines regulatory expertise, structured processes, and practical MDR knowledge to support manufacturers throughout their European journey.

Still have questions? Checkout our FAQ

1. What is a European Authorized Representative?

A European Authorized Representative is a natural or legal person established within the European Union who is formally designated by a manufacturer located outside the EU to act on their behalf in fulfilling specific regulatory obligations under Regulation (EU) 2017/745 (EU MDR).

2. When is a European Authorized Representative required?

A European Authorized Representative is required when a medical device manufacturer is established outside the European Union and intends to place medical devices on the EU market. Without an appointed representative, devices cannot be legally marketed in Europe.

3. What are the main responsibilities of a European Authorized Representative?

The responsibilities are defined under Article 11 of the EU MDR and include verification of documentation, availability of technical files and declarations to competent authorities, support with registration obligations, communication with authorities, cooperation on preventive or corrective actions, and forwarding of complaints or incident information to the manufacturer.

4. Does the European Authorized Representative take responsibility for the device?

No. The manufacturer remains fully responsible for the safety, performance, and compliance of the medical device. The authorized representative does not assume manufacturer responsibilities but supports regulatory oversight and communication as defined by the EU MDR.

5. Can one European Authorized Representative cover multiple devices?

Yes. A European Authorized Representative can represent multiple devices or product families, provided they are clearly defined within the mandate and covered under the agreed scope of services.

6. How does the transition from a previous Authorized Representative work?

When changing authorized representatives, a formal transition process must be followed in accordance with Article 13 of Regulation (EU) 2017/745. This includes defining responsibilities between the former and new representative to ensure regulatory continuity.

7. How does Sobel support manufacturers as a European Authorized Representative?

Sobel acts as a European Authorized Representative in line with EU MDR requirements, providing structured regulatory oversight, documentation availability, authority communication, and support throughout the product lifecycle to help manufacturers maintain compliant and transparent market access in Europe.