The European Commission has announced a proposal to delay enforcement of the EU Medical Device Regulation by one year, from 26 May 2020 to 26 May 2021.  The intent is to help relieve pressure from national competent authorities, notified bodies, industry and the Commission itself.  This will allow them to focus fully on more urgent priorities related to the COVID-19 crisis.

 

We understand today’s immediate challenges facing the medical device industry – and certainly the worldwide impact of COVID-19.  We offer our best wishes for the health and safety of our colleagues, partners, customers and all those in our industry confronting these difficult times.  The Innovit team stands ready to assist and will proudly continue offering support, especially with master data quality and UDI compliance in order to help you and the broader healthcare community improve public health.

 

No doubt many of you will be wondering, “Will EUDAMED implementation be postponed accordingly – again?”  We will continue to update you as information becomes available.