COVID-19 Update: ABHI Backs Call to Delay MDR & IVDR Transition
Topic : News and Press Type : Briefing
Due to the ongoing COVID-19 pandemic, MedTech Europe has this week formally requested a pause in the implementation of the new Medical Device and In-vitro Diagnostics Regulations (MDR/IVDR). ABHI fully supports this position and has asked UK Ministers and officials to make appropriate representations. In this blog, Phil Brown offers some further thoughts.
Authorities are, rightly, focussing on managing this public health emergency, with little resource currently available for their MDR/IVDR implementation duties. COVID-19's impact has prevented many Notified Body audits from happening, leading to delays in conformity assessment, and the majority of clinical studies have been stopped. This, notwithstanding the well-documented challenges the transition period has brought about.
This action, which suggests a moratorium until such time that the health situation has stabilised, is aimed at maintaining the availability of HealthTech needed within healthcare systems in the fight against COVID-19.
ABHI remains fully committed to the ambitions of the new regulations and we look forward to ensuring their success after this temporary emergency measure has concluded.