An overhaul of the EU medical devices framework in 2012 was designed to revamp some obsolete rules dating back to the 1990s and improve safety and availability of these products. Specific provisions were approved in 2017 for in vitro diagnostic medical devices, which range from glucose meters for diabetes monitoring to pregnancy kits, as well as tests to detect viruses such as HIV or coronavirus. New requirements for in vitro medical diagnostics are formally to apply from May 2025 for high-risk tools and May 2027 for low-risk ones. As the deadlines draw near however implementation of these rul…