European Authorized Representative
European Authorized Representative
If you’re a medical device manufacturer outside the EU, appointing a European Authorized Representative (EAR) is a legal requirement under the EU MDR regulation 2017/745. This role bridges the gap between your company and European authorities, allowing your products to enter and remain on the EU market with full regulatory oversight.
You don’t need to have a branch in Europe! We act as your Authorized Representative in the European Community, providing trusted, proactive support to help you meet all MDR obligations and navigate the European regulatory system with confidence and transparency
How We Support Your European Regulatory Compliance
An EAR is a natural or legal person established within the EU who has received and accepted a written mandate from a manufacturer located outside the Union to act on their behalf in fulfilling specific legal obligations.
This includes verifying compliance, handling documentation, and communicating with competent authorities under EU MDR 2017/745.
As your European Authorized Representative for medical devices, Sobel provides:
Verification that your EU Declaration of Conformity and technical documentation are properly prepared and the correct conformity assessment has been performed
Availability of required documents for competent authorities, including the Declaration of Conformity and relevant certificates
Fulfillment of registration duties as outlined in Articles 27, 29, and 31 of the MDR
Communication with EU authorities on your behalf, including responding to documentation or device access requests
Forwarding requests for samples or inspections to your team and coordinating their delivery
Collaboration with authorities on preventive or corrective actions
Immediate reporting of complaints or incidents to your team
Termination of the mandate if non-compliance is identified
Full transition support when switching from a previous EAR (as per Article 13 of MDR)
Why do you need this service?
If your company doesn’t have a legal presence in the EU, you cannot market medical devices without an EU Authorized Representative. We provide the structure and credibility you need to comply.
We act as your official point of contact with European regulatory bodies, helping you manage requests, inspections, and incident reporting swiftly and professionally.
With deep knowledge of the EU MDR regulation, we check if your documentation, registration, and post-market responsibilities are handled with precision.
With a trusted representative in place, you reduce regulatory risk, strengthen your market position, and ensure that your company is always one step ahead in a highly regulated environment.
Looking for European Authorized Representation Assistance?
Appointing the right European Authorized Representative is more than a checkbox—it’s a strategic move. Let Sobel be your trusted partner in the European Market! By choosing Sobel, you gain a partner that combines regulatory expertise, operational clarity, and full alignment with MDR requirements.
Take the next step toward effortless EU market compliance!
