Module 15 Presentations

4/15/2024

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

Presented by:

Adrian Keene, Associate Vice President, Global Biological Safety and Validation and EMEA Consulting Services

Date:

April 2024

© NAMSA 2021

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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

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© NAMSA 2021

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