Medical device regulations have been on the books for decades, long before software was widely used in medical devices, and certainly well before the advent of software as a medical device. While these regulations get modified over time, they always lag behind industry and are still largely written for physical products delivered through physical distribution channels. As such it's understandable that SaMD and Digital Therapeutics (DTx) developers might be confused about the new importer requirements (Article 13) in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The three most common questions about how Article 13 impacts manufacturers of SaMD and DTx deal with liability, listing and labeling.
1. LIABILITY: Your importer can be held financially liable for your compliance with the EU MDR
The new MDR and IVDR define what it means to “place [devices] on the market.” Why is this relevant? According to the regulations only a manufacturer or importer can place a product on the European market for the first time and whomever takes on this role is potentially financially liable for the manufacturer’s compliance with the MDR and IVDR. Under that definition, when you sell as a non-EU based manufacturer directly to your end user without a designated importer, your end user can be considered the importer for your device. Obviously, none of your end users are aware of this and would never agree to use your software if they knew they had financial liability and compliance responsibility associated with the role and obligations of the importer. Thus, if your company does not have an affiliate entity registered in the European Union or a distributor that is willing to take on the role of EU importer, it’s best to have an independent importer file this role.
2. LISTING: You must list your importer in EUDAMED
You may have heard about EUDAMED, the new medical device and IVD database slowly being rolled out by the European Commission. Although currently voluntary, all device manufacturers and importers will be required to register in EUDAMED, and manufacturers must list their appointed importer(s) for each product. Again, because your EU importer is financially liable for MDR/IVDR compliance of your software and must perform specific checks for compliance, it is essential for manufacturers of SaMD and DTx without a local legal entity in Europe to appoint a qualified importer in the EU to take on those responsibilities. Sorry, you cannot use an EU-based virtual office “address” as your importer.
3. LABELING: Your importer must be clearly identified on your product “labeling”
Finally, there’s the issue of labeling. You’ve already had a taste of how to deal with the labeling issue because you’ve been doing it all along for your EU Authorized Representative. Article 13(3) of the EU MDR and IVDR impose very similar requirements in saying that: “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.” Again, that language is appropriate for physical devices. Section 3.1 of ISO 15223-1 clarifies that “accompanying information is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types e.g. CD/DVD-ROM, USB stick, website.” Also see Chapter III of Annex I in the MDR.
If your company neglected to appoint an importer, you would be out of compliance with the MDR and IVDR. What might happen? Well, for one thing your Notified Body will surely notice that you have not appointed an importer during your audit, which could delay issuance of your CE Marking certificate. Even if that was overlooked, a European Competent Authority (Ministry of Health) may notice that you have not appointed an importer in EUDAMED and can impose huge fines for non-compliance. Given the small cost to appoint an independent importer it’s not worth the risk.
Play it safe and maintain your independence in Europe
For some, the new requirement to appoint an importer seems like a compliance redundancy. Yet, the new rules underscore how serious European regulators are about verifying compliance with the MDR and IVDR. The best option for most SaMD and DRTx manufacturers is to outsource the role of importer, just as you do now for your EU Authorized Representative.