1 December 2016 -
12:00 to 13:15

The New Medical Device Regulation – How to Hit the 2020 Deadline (pdf)

Market Access & Regulatory

Studio 4 (2nd floor)

The New Medical Device Regulation contains significantly more detail than the current Directives. Over 300 pages in draft form, and containing in excess of 50 delegated and implementing acts, how the needed secondary legislation and guidance is both prioritised and developed will fundamentally determine how effectively and smoothly both the regulators and the regulated industry can transition to the new Regulation. This session aims to demystify the Regulation and give insights into the path forward, allowing businesses to plan for the impacts and the uncertainties ahead.

Speakers
Director Regulations & Industrial Policy - MedTech Europe
Head of Unit for Health Technology and Cosmetics - DG for Internal Market, Industry, Entrepreneurship and SME (DG GROW) - European Commission
Deputy Head of Unit for Health Protection - DG Health and Food Safety (DG SANTE) - European Commission
Director of Devices - Medicines and Healthcare products Regulatory Agency (MHRA)
Chair - Competent Authorities Medical Devices (CAMD)
Moderator
Communications Strategist - Flare-Innovation