Under the new European IVD Regulation (IVDR), the compliance requirements for companies are substantially different to what 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?

In this ABHI virtual conference we will review how best to embed the requirements of IVDR into your organisation, taking into account key commercial considerations including product development and market access.

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.

View the agenda here.

Confirmed speakers:

• Oliver Bisazza - Director, Regulations & Industrial Policy, MedTech Europe
• Phil Brown - Director, Regulatory & Compliance, ABHI
• Anna Hallersten - Director - Head Regulatory Policy Europe , Roche
• Liz Harrison - Technical Team Manager - IVD, BSI
• Jenny Keating - Senior Regulatory Policy Manager, MHRA
• Steve Lee - Director, Diagnostics Regulation, ABHI
• Celia Mortimer - Senior Regulatory Policy Manager, MHRA
• Dr Julia Riedlinger - IVDR Program Lead, Roche
• James Shearn - Head of Regulatory Affairs, Oncimmune