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.