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THE NEW REGULATORY OUTLOOK FOR DEVICES, IVDS AND COMBINATION PRODUCTS

Track:
Regulation of Medical Devices and Combination Products

Day & Time:
March 27, 11:00AM - 12:30PM (Central European Standard Time)

Session Number:
1106

Room Number:
Room I

Type:
Session

Title:
THE NEW REGULATORY OUTLOOK FOR DEVICES, IVDS AND COMBINATION PRODUCTS

Chair(s):
Shayesteh Fuerst-Ladani, MBA, MS
Director
SFL Regulatory Affairs & Scientific Communication, Switzerland

Description:
This session will outline major changes in the forthcoming EU Regulations on medical devices and IVDs and how they impact drug/device combination products and companion diagnostics. It will summarise the latest developments at a critical time in the history of medical device regulation.

Presentation(s) & Speaker(s):
Forthcoming Major Changes to the New EU Medical Device Regulation
Elitsa Mincheva
DG Health and Consumers
European Commission, Belgium

How the Regulation of Drug/Device Combinations will Change under the New Medical Device Regulation
Shayesteh Fuerst-Ladani, MBA, MS
Director
SFL Regulatory Affairs & Scientific Communication, Switzerland

Notified Bodies Perspective on the Revision of Medtech Regulation
Theresa Jeary
Technical Manager
LRQA, United Kingdom