Can We Appoint Multiple EU Importers in Compliance with the EU MDR and IVDR?

Many medical device companies exporting to Europe have discovered that there is a new requirement to appoint an importer in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Article 13 in both regulations makes it clear that the importer plays an important role alongside your European Authorized Representative (EAR), distributor, and Personal Responsible for Regulatory Compliance (PRRC). You can read more about the role of the importer here.

EU Importer Under MDR and IVDR

Article 13 does not say you must only appoint a single importer to represent all of your devices in Europe. Your company may use an existing legal European entity (not just a sales office) as your official importer. More commonly small to mid-sized device companies will have a single Authorized Representative and multiple distributors in different countries. While it’s true that your distributors may agree to act importer for the markets they service, most will choose not to do so once they learn about the obligations of the importer and associated liabilities we outline here.

Considerations Before Asking Distributors to Act as your EU Importer Under the New MDR and IVDR:

1. Labeling Requirements

Let’s say you have 10 distributors throughout Europe and you want each one to fulfill the responsibilities of importer on your behalf. Yes, you can do that. However, remember that under the MDR and IVDR, your importer must be clearly identified all the way to the point where the product is put into service.

Here’s what Article 13(3) says: Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trademark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.”

MedEnvoy can act as your independent EU importer. Request a proposal.

We emphasize that you need to think about how you are going to handle the logistics of having multiple distributors appointed as importers with regard to labeling (or inserts). Thinking about asking just one distributor to act as importer for all of Europe? Again, imagine the confusion when a distributor in Germany is listed as importer for products being shipped to another distributor in Italy. The potential for confusion, animosity and error is high.

2. New Contracts with Distributor for Added Liability 

If a manufacturer is not in compliance with the EU MDR or IVDR, European Competent Authorities can impose huge fines and the importer is responsible for paying the bill. The importer can be held financially liable for your compliance in Europe. This is why most distributors, logistics companies and authorized representatives shy away from taking on the added responsibility. If they agree, it is likely they will want to modify or replace your existing contracts, demand higher liability insurance and access to your technical files. Do you really want to mess around with that?

To learn more about how you can streamline your medical device to the EU market, click here.

Avoid Many Issues by Appointing a Single Importer 

You can avoid many of the labeling and contracts hassles associated with having multiple importers by appointing just one instead. One point of contact. One contract. One team responsible for your compliance.

MedEnvoy as Your Importer Under the New MDR and IVDR

MedEnvoy has been working with medical device and IVD manufacturers since 2005. We understand the importer requirements and compliance issues associated with the MDR and IVDR. To contact our team, click here. To learn more specifically about our EU importer service, click here.

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