EU Authorized Representative for Medical Devices

When applying for MDR (Medical Device Regulation) assessment with a Notified Body, as a non-EU manufacturer, you may be required to provide information about your eu authorized representative (as shown in the image below). This representative is referred to as the "european authorized representative," abbreviated as AR or EAR.

Why You Need an EU Authorized Representative

According to Article 11(1) of the MDR, if you are a non-EU manufacturer and intend to market your medical device in the EU, your product must be linked to one, and only one, EU Authorized Representative—regardless of its risk classification. This requirement applies even to Class I devices, which do not require a Notified Body review.

As a non-EU manufacturer, you cannot register your products directly with the EU regulatory database. Your EU Authorized Representative must handle this registration on your behalf.

Our Core Responsibilities as Your EU Authorized Representative

As your sole EU Authorized Representative, we will fulfill the following key responsibilities as mandated by EU regulations:

a. Verify that your technical documentation and Declaration of Conformity meet EU regulatory requirements, and that your conformity assessment procedures are appropriate.

b. Retain copies of your technical documentation and Declaration of Conformity. For devices above Class I, we must also retain your ce certificate for inspection by competent authorities.

c. Register your products on the website of the German competent authority.

d. Respond to inquiries from competent authorities and provide documentation proving compliance—in the official language (German).

e. If competent authorities request product samples, we will coordinate with you and ensure that samples are delivered as required.

f. In the event of a Field Safety Corrective Action (FSCA), such as recall or onsite disposal, we must cooperate closely with the competent authorities.

g. Forward any customer complaints or incident reports to you immediately.

Most importantly, as your EU Authorized Representative, we will share legal liabilitywith you in the event of a serious incident involving a defective device.

Additionally, when entering other countries or regions, local regulatory authorities may require a Free Sales Certificate(FSC) issued by the EU. Only an EU Authorized Representative can apply for and obtain this certificate from the competent authorities.

Additional Services We Offer

1. If your product is Class I and lacks a technical file, we can assist in creating one.

2. After reviewing your technical documentation, we will promptly inform you of any necessary improvements.

3. If you are unfamiliar with Basic UDI-DI(not UDI-DI), a special EU regulatory requirement, we can help generate it for you.

4. At the annual MEDICA trade fair in Düsseldorf, we host our own booth. If needed, we can create promotional brochures featuring your products and distribute them to potential distributors.

5. If your product is distributed in the EU without an official importer, we can act as your importer.

6. If you encounter regulatory issues at EU customs, we are happy to assist in resolving them.

7. For other EU compliance requirements, such as obtaining a WEEE numberfor active devices, we can apply on your behalf.

8. For high-risk medical devices requiring clinical trials, we also serve as a CRO (Contract Research Organization)and can manage clinical trials in the EU on your behalf.

Our Quality Assurance as Your EU Authorized Representative

Our Regulatory Affairs Manager in Germany has extensive experience with audits from German competent authorities, both as a manufacturer and as an Authorized Representative. We are highly familiar with regulatory expectations.

We guarantee that any product registration or request for a Free Sales Certificate will be submitted to the competent authorities within three working days, and we will actively follow up to expedite processing.