Module 15 2022

5/19/2022

Lecture 1: Current status of the EU Medical Device Regulation 2017/745 Impact overview for Clinical Evaluation

Presented by:

Adrian Keene, Senior Director, Global Biological Safety and Validation and EMEA Consulting Services

Date:

May 2022

© NAMSA 2021

1

MDR history – how did we get here?

• 2008 – “recast” of existing AIMD and MDD • Consolidate 5 amending directives

• 2012 – proposals issued

• PIP • Ruptures reported as early as 2006-2007 • AFSSAPS (now ANSM) on site inspection March 2020 • Unapproved implant filler • 2013 – CEO sentenced to 4 years imprisonment • 300,000 women in 65 countries effected • EU Commission Action plan

2

© NAMSA 2021

2

1