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 is considered an “Economic Operator” with an important role to play 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.
There is nothing in Article 13 that says you must only appoint a single importer to represent all of your devices in Europe. If your company already has a legal European entity (not just a sales office) in the European Union, that entity may serve 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.
Issues to consider before asking distributors to act as your EU importer.
Labeling – 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 but remember that – like the Authorized Representative – 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.”
While that language makes it seem as though you could add a flyer with your importer name and slide it inside a larger multi-unit pallet being shipped to a distributor, this is not the intent of Article 13. The whole reason the importer requirement was put into place was to add another layer of checks ensuring compliance with the EU MDR and IVDR. Although it is still “early days” and not yet well defined you should honor the spirit of the Article (and to avoid the issues with your Notified Body or Competent Authorities) by making sure your importer is clearly identified.
We emphasize this because 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) and how to keep that all straight. Thinking about asking just one distributor to act as importer for all of Europe? Again, imagine the confusion created when ABC Medical Device Distributors GmbH in Germany is listed as importer for products being shipped to another distributor in Italy. The potential for confusion, animosity and error is high.
Contracts – If a manufacturer is not in compliance with the EU MDR or IVDR, European Competent Authorities are authorized to impose huge fines. Guess who gets the bill: your importer, who can be held financially liable for your compliance in Europe. That’s why most distributors, logistics companies and authorized representatives shy away from taking on the added responsibility. If they do 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?
Appointing a single importer avoids many issues
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. Our team has been working with medical device and IVD manufacturers since 2005 and we understand importation and compliance issues associated with the MDR and IVDR.