Module 19: Regulation of In Vitro Diagnostic Medical Devices

Module 19: Regulation of In Vitro Diagnostic Medical Devices

Date: 18 – 20 April 2023

LOCATION: TOPRA OFFICE, LONDON, UK / ONLINE

Module Leader(s) : Nancy Consterdine & Stuart Angell

Day 3: Thursday 20 th April 2023

Time

Activity

Speaker

Review of day 2

Nancy Consterdine, IVDeology

Interactive session to reflect on learnings from day 2, answer any questions and confirm understanding Case Study: Apply learnings on performance data & product claims in a group setting using real life examples

09.00 – 09:30

Nancy Consterdine,

09:30 – 10.30

IVDeology

Morning break

10.30 – 10.45

Lecture 10: Other Regulated Markets Which are they? How are they different? How can we drive harmonisation? Who are IMDRF

Nancy Consterdine, IVDeology / Maurizio Suppo

10.45 – 12:30

Lunch

12:30 – 13.15

Lecture 11: Other Legislation

Nancy Consterdine, IVDeology

Beyond IVDR. What about REACH, RoHS WEEE, GDPR, Machinery Directive and more

13.15 – 14.15

Afternoon break

14:15 – 14.45

Lecture 12: Companion Diagnostics and the IVDR What this means for co-development and personalised medicine

14.45 – 15.45

Maurizio Suppo

15.45

Close of Module