Topping the news this week is the European Commission’s proposal for medical device legislation. Eucomed by and large welcomed the measures with one huge caveat regarding the scrutiny procedure (Article 44). The association notes that the procedure “will fundamentally change the current [regulatory] system and will not lead to the desired outcome of increased safety for patients.” Eucomed Chief Executive Serge Bernasconi spoke at some length about the mechanism on medtechinsider. For an explanation of how the scrutiny procedure would actually work, complete with a graphic representation of the mechanism, see What Is the Scrutiny Procedure on the Eucomed website. Medico-legal specialist Erik Vollebregt offered his first impressions on medicaldeviceslegal.com, noting that there was nothing unexpected but that the devil, as we know, is in the details.
Also making waves this week, the hackability of medical devices continues to raise concerns. US lawmakers urged US FDA to increase its focus on the potential for intentional threats to device security, noted Fierce Medical Devices. The US Department of Health and Human Services agrees that US FDA needs to revise its approach to medical device safety and security to consider the threat of intentional tampering, reported massdevice.com.
— The Editors