ABHI Diagnostics Regulation Conference

Under the new European IVD Regulation (IVDR), the compliance requirements for companies are substantially different towhat has come before, moving away from a majority self-certification process, towards a system with significantly greater notified body conformity assessment. With an estimated 80% of IVDs now falling under this new route, and with under two years to go until the regulations take effect, the question is, are you ready for IVDR?

As we delve into the readiness of the system, a host of experts will be on hand to answer your questions, with practical examples from companies both large and small, whose IVDR compliance journey is already underway. We will also explore what we can expect in a post-brexit world; how will the IVDR impact manufacturers wishing to access the UK market after January 1st?

Event speakers will include senior representatives from the MHRA, notified bodies and industry and will be Chaired by ABHI’s new Director of Diagnostics Regulation, Steve Lee.

For more details including agenda and confirmed speakers, see: https://www.eventbrite.co.uk/e/abhi-diagnostics-regulation-conference-tickets-116222832621