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EU Authorized Representative
EC REP Services for Medical Device & IVD Manufacturers 

More Consolidated. More Convenient. More Control.

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Optimize your regulatory compliance and control with MedEnvoy as your European Authorized Representative for medical device & IVD manufacturers.

Europe’s Most Comprehensive Representation Provider

Why do you need a European Authorized Representative? If you are a medical device or IVD manufacturer without a registered office in the EU, you must appoint a local European Authorized Representative (EAR) to meet the requirements of the EU MDR or IVDR. MedEnvoy provides this service.

 

Our primary role as your EC REP is to act as the liaison between you and the authorities within the Union and support your company with issues related to Post Market Surveillance and vigilance.

A European Authorized Representative may also be known as an EAR, CE REP, MDR REP or EU REP. All of these mean the same thing: European Authorized Representative.

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MedEnvoy represents more than 550 medical device & IVD manufacturers worldwide!

As Your EU Authorized Representative We Will:

Perform a completeness review of your CE technical documentation and confirm that you have carried out an appropriate conformity assessment procedure

✓ Verify that the device labeling fulfills the requirements of the MDR/IVDR

✓ Keep a copy of the technical documentation at the disposal of the competent authorities to demonstrate the conformity of the device

✓ Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by the medical devices

✓ Inform the manufacturer about complaints or reports from healthcare professionals, patients, and users about suspected incidents related to the device

✓ Your selected EC REP must be identified on the device labeling!

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Commonly Asked Questions About Our European EC REP Services for Medical Device Manufacturers

What is a European Authorized Representative?

An EU Authorized Representative is defined as being any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks about the latter’s obligations under the Regulations. The EU Medical Device Regulation (EU MDR 2017/745) and the European In Vitro Diagnostic Regulation (EU IVDR 2017/746) describe the general obligations more in MDR/IVDR Article 11.

Why is a European Authorized Representative necessary?

According to the EU Medical Device Regulation (EU MDR 2017/745) and the European In Vitro Diagnostic Regulation (EU IVDR 2017/746) a manufacturer established outside the European Union is obliged to appoint an Authorized representative within the EU. The Authorized representative acting on behalf of the manufacturer is responsible for medical devices placed on the European market.

How do I appoint a European Authorized Representative?

Identify any natural or legal person established within the European Union who is willing to act in this capacity and is willing/able to sign a legally binding agreement appointing themselves as your European Authorized Representative.

How do the roles of a European Importer and European Authorized Representative differ?

One of the key differences between the Authorized Representative and the Importer has to do with exposure. Your contract with your Authorized Representative considers the fact that they can be held legally liable for your defective devices sold in Europe per MDR Article 11(5). Similarly, your Importer has significant exposure in that they can be held financially liable for your non-compliance with the MDR.

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Convenient. Consistent. Responsive.

Three European Markets. One Representative.

Let’s Get Started!

Ask a question or request a free, no obligation proposal