January 25, 2024

EU MDR Virtual Importers

While I can see potential benefits of voluntarily creating an importer (along with the additional regulatory burden) to add a layer of compliance checks and balances, I strongly advise against the basis being an assertion that end users need regulation because they have, as one person said, “taken up responsibilities regarding safety and performance”. That in my opinion opens the door to more frivolous litigation against healthcare providers and/or manufacturers, and to more burdensome overregulation. It also seems to run contrary to a most fundamental tenet of Europe’s longstanding “common framework” and regulatory approach, which is to distinguish regulated economic operators and protect the public stakeholders on whom, or by whom, the devices are used.

If such a “virtual” (my terminology) importer is voluntarily invented/created by the stakeholders, then the manufacturer needs to remember that it will be required to execute a placing on the market of those devices to said virtual importer.  Specifically, the manufacturer and importer would be required to execute (and thereafter be able to prove) that there was an offer or an agreement (written or verbal) by the manufacturer to transfer ownership, possession or other property right concerning the product in question to the importer rather than the end user.  Again, such an arrangement could certainly be of value to reduce liability risk in those cases where the manufacturer has the bandwidth for such voluntary additional regulatory burden.  In fact, I have advised clients to do this at times, though not based on asserting that the end users had taken up responsibilities regarding safety and performance.