The Medical Devices Introductory Course 2020

The Changing EU Medical Device Regulatory Landscape

• Media Impact - PIP Scandal, undercover NB scam and metal-on-metal hip, surgical mesh implants

• Joint Plan for Immediate Action (“PIP Action Plan”) ● Unannounced audits ... restoring confidence?

 New Medical Device / IVD Regulations

Swixit, Turkxit ..?

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The EU Medical Device & IVD Regulations 2017/745 & 2017/746

The Organisation for Professionals in Regulatory Affairs

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2017:117:FULL&from=EN