Seamlessly Ensure Device Compliance with the EU’s Leading Authorized Representative
Optimize your regulatory compliance and control with MedEnvoy as your EU Authorized Representative for medical device and IVD manufacturers.
Europe’s Leading Authorized Representative 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 (EU AR/EAR) to meet the requirements of the EU MDR or IVDR. MedEnvoy provides this service. A European Authorized Representative may also be known as an EAR, EU AR, EC REP, CE REP, or EU REP.
Are You Looking to Transfer?
If you are dissatisfied with your current EAR support, pricing, or other aspects, MedEnvoy can help. With extensive experience, we’ve successfully transitioned over 150 medical device and IVD manufacturers to MedEnvoy. We’ll manage the entire process, including preparing a tripartite agreement to ensure a smooth and cost-effective transition, compliant with MDR and IVDR requirements.
EU In-Country Representation for Medical Device and IVD Manufacturers
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 EU AR must be identified on the device labeling.
FAQs
How do the roles of an EU Regulatory Importer and EU 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.
How do I appoint an EU 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.
Do we need to translate the label and the IFU into the respective languages of the markets where we place the product? Are there any exceptions?
It is MedEnvoy’s understanding that the labels and IFUs of your products must be translated into the language(s) of the countries where they are placed on the market, even if they are for professional use only. However, if your Authorized Representative or Notified Body has explicitly informed you that your current setup (IFUs for professional use in English only, with customer approval required) is acceptable, then it is also acceptable for us. Please discuss this with your EAR and/or NB.
What is a Single Registration Number (SRN) in EUDAMED?
The SRN number is the number by which your company will be identified in the EUDAMED database and all official regulatory documents in the EU. It is generated through the EUDAMED system after your registration there is validated by the relevant Competent Authority and (if applicable) your Authorized Representative.
Do System and Procedure Pack Producers (SPPP) have to register as actors in EUDAMED?
According to Article 29 (2) MDR, before placing a system or procedure pack on the market, the natural or legal person responsible (SPPP) has an obligation to assign a Basic UDI-DI to be provided to the UDI database, together with the other data referred to in Part B of Annex VI MDR.
Why is an EU 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.
UK Responsible Person
Swiss Authorized Representative
US FDA Agent
Mexico Registration Holder
Egypt Registration Holder
Saudi Arabia Authorized Representative
India Agent
Australian TGA Sponsor
New Zealand Sponsor
Isreal Registration Holder
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