How the New MDR/IVDR Applies to Selling Software as a Medical Device (SaMD)

April 23, 2021

4 mins

EU MDR EU IVDR EU Importer General

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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. However, these regulations are often written behind industry and are still largely written for physical products delivered through physical distribution channels. As a result, software developers might be confused about the new importer requirements (Article 13) in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

How the New MDR/IVDR regulations can impact software manufacturers

Three of the biggest questions about how Article 13 will impact 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 importer role specified by the MDR and IVDR. 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

The European Commission has slowly been rolling out a new medical device and IVD database called EUDAMED. 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, under MDR, it’s essential for software manufacturers without a local legal entity 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.

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

3. Labeling: You must clearly identify your importer on your product “labeling”

Finally, there’s the issue of labeling. You’ve already had a taste of how to deal with labeling because you’ve been doing it 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.

Not appointing an importer can cause significant setbacks

If your company sells software as a medical device and does not appoint an importer, you will be out of compliance with the MDR and IVDR. What might happen? Well, for one thing your Notified Body will see that you have not appointed an importer. This 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.

Comply with MDR as a software manufacturer

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.

MedEnvoy can fulfill the role as Importer

We hope this helps clarify how the new MDR and IVDR applies to selling software as a medical device (SaMD). If you have additional question, don’t hesitate to reach out!