The MHRA’s new guidance on standalone software as medical device and DIA Euromeeting update

A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between the lines of the existing MEDDEV on standalone software (which itself is under revision currently but seems to have been bogged down considerably in the responsible MDEG because of a competence struggle between the software MDEG and the borderline MDEG), so the added value is limited for those that alread [...] « Read the rest of this article on medicaldeviceslegal »