EU Regulatory Importer for Medical Device and IVD Companies

Optimize compliance with MedEnvoy as your trusted EU MDR and IVDR importer for medical device and In Vitro Diagnostics (IVDs) manufacturers.

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Independent EU Regulatory Importer Representation

Are you wondering why you need to consider an EU MDR/IVDR importer when you already may have distributors to take on the role of importer? The reason is that Article 13 of the EU MDR and IVDR now allocates specific responsibilities and obligations to the importer, the only other economic operator that takes on the responsibility for placing your devices on the European market if the legal manufacturer does not have a place of business in the Union. To take on the responsibility and obligations of the importer as defined in the MDR/IVDR, the importer is not required to take physical possession of your devices, but they do play a vital role in device compliance, post-market surveillance (PMS), vigilance, and traceability of devices.

Regardless of whether you are selling legacy devices holding existing CE certificates under the MDD/IVDD or devices with CE under the MDR/IVDR, the role of the importer is required by the MDR/IVDR.

Expert EU MDR/IVDR Importer Service for Ensuring Ongoing Compliance

By engaging MedEnvoy as your designated independent EU MDR or IVDR importer, you are entrusting this role to expert regulatory professionals who will ensure your ongoing compliance by efficiently performing the responsibilities and obligations of the importer.

As your designated EU Regulatory Importer, we will:

Check EUDAMED registration of all economic operators.
Verify that devices placed on the EU market include CE Marking.
Verify that EU declaration of conformity and technical documentation exists.
Verify instructions for use and accompanying information with the device.
Verify labeling includes manufacturer, EC REP, and importer contact details.
Verify that MDR/IVDR storage and transportation requirements are fulfilled.
Maintain a register of complaints as required in Article 13.
Report serious incidents or risks to the competent authority, if applicable.
Maintain traceability of the device in the supply chain.

FAQs

What is the difference between EU MDR distributor vs. importer?

EU MDR Chapter 2 Article 13 outlines the general obligations of importers while EU MDR Chapter 2 Article 14 outlines the requirements of distributors. The biggest difference is that under the EU MDR the importer is responsible for “placing a device from a third country onto the European market,” whereas the distributor is not liable.

Do I need an EU MDR importer and authorized representative?

The short answer to this question is no; however, most authorized representatives that we have spoken to are not willing to act as the importer due to the increased liability that the importer assumes in their role. Having said that, MedEnvoy is one of the first organizations to offer both EU MDR/IVDR importer and authorized representative services under one organization. By doing so, we eliminate the need for even more economic operators as suppliers and streamline various activities such as EUDAMED registrations and post-market surveillance activities.

Is obtaining the CE Mark the only requirement under the MDR?

No, obtaining the CE Mark is just the beginning; the MDR involves a comprehensive risk-focused life-cycle approach with ongoing regulatory obligations.

What support does MedEnvoy offer for bringing new devices to market or transitioning legacy devices under the MDR?

MedEnvoy can assist at every step, providing support for both new devices entering the market and the transition of legacy devices under the MDR.

Is there a transition period for legacy devices under the MDR?

Yes, legacy devices benefit from a transition period that extends through 2027 or even 2028, depending on the device classification.

What if we ship to an EU country and then export onward to another EU country?

Your devices will need to be cleared by customs for the European Union at the first point of entry. After that the EU allows the free movement of products, just as the US does between individual states.

Our device has a valid MDD CE certificate. Do we need to comply?

Even if you hold a valid Medical Devices Directive (93/42/EEC) certificate that expires as late as 2024, and even if you don’t make any changes to the product whatsoever, there are certain aspects of the MDR you must meet going forward from May 26, 2021. One of those is the need to appoint an EU importer.

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