The Regulation was evaluated in 2016 as part of the Commission's regulatory fitness and performance programme (REFIT) including on the scope of countries and diseases and general criteria for the implementation of Article 3.
Määrust, sh riikide ja haiguste loetelu ning artikli 3 rakendamise üldisi kriteeriume hinnati 2016. aastal komisjoni õigusloome kvaliteedi ja tulemuslikkuse programmi (REFIT-programm) raames.