Many medical device manufacturers located outside the European Union have been wondering what to make of Article 13 of the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Article 13 highlights the responsibilities of the Importer and affirms the important role it plays in supply chain traceability. Under the MDR and IVDR, the Importer is considered a critical “Economic Operator” along with Manufacturers, Authorized Representatives and Distributors. (You can learn more about what the importer does here.)
Nonetheless, manufacturers located outside Europe are understandably perplexed by what happens if they do not specify an entity or person located in Europe to act as their Importer. Here’s what you need to know.
You already have a European importer, and there’s a very good chance they don’t want to be your importer
A key concept in European law involves understanding the “placing [a device] on the market.” Under the MDR and IVDR, only the manufacturer or importer can place a device on the European market the first time. European-based manufacturers act as their own importer but in the case of non-EU manufacturers shipping devices to a distributor or retailer, the recipient (or their 3PL provider) would be placing the device on the EU market and unwittingly take on the role of importer along with all of these importer responsibilities. In addition to verifying manufacturer compliance with the MDR or IVDR, there is also significant financial liability associated with the role.
Don’t underestimate the labeling requirements
There’s another big problem that comes with NOT specifying an importer: labeling. According to Article 13 of the MDR…
“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.”
If you do not actually specify who is acting as your importer in each EU country where you sell, that role defaults to all of your distributors or retailers. Given the language associated with Article 13 above you can see how this would quickly create a labeling nightmare. This is why smart manufacturers appoint an independent EU importer to represent them in all EU markets, just as they do an Authorized Representative.
You could be left scrambling to find an importer at the last minute
Even if you hold existing MDD certificates that expire in 2024, Article 120(3) of the MDR makes it clear that you still need to comply with the importer requirements among other things. A snippet of Article 120(3) is shown below and here’s a more in-depth look at that topic.
“…the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.”
Thus, if you wait until your next Notified Body audit, they may ask who is acting as your importer in Europe. Savvy distributors may also wise up about the liability they are taking on and refuse to take on that responsibility, forcing you to quickly find an independent importer and update labeling as required.
EUDAMED: an evolving tool for supply chain traceability
The first module of the new EUDAMED medical device database became operational at the end of 2020. This database will be used by all European Competent Authorities and Notified Bodies to track devices, manufacturers and their associated importers, distributors and Authorized Representatives. Manufacturers, Importer and Authorized Representatives (but not distributors) can register their company in EUDAMED and obtain a Single Registration Number. Even though EUDAMED registration is currently optional, it will be important to be linked to an Importer(s) to prevent questions from authorities about who is the importer(s) of your devices in the EU, especially if you are not located in Europe. Doing so early on will save you plenty of headaches down the road.