Modules for clinical investigation and market surveillance might be only “partly or not at all available” at the time of application of the two EU medtech regulation (the MDR, and its sister IVDs regulation in force two years later), and not fully operational until few months after the respective deadlines. This is due to “workability issues,” the European Commission says in its Rolling Plan.
The plan was updated recently, without fanfare, on the Commission's website. The aim is still to have the updated Eudamed go live on March 25, 2020, i.e. in...
