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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