Updated Medical Device Regulations for the European Union | Page 2

Updated Medical Device Regulations for the European Union:
What’s In, What’s Out, and What’s Hot
Figure 1. EU

Introduction »

Medical Device Overview1

If you work in the medical device industry, you know that items such as cardiovascular

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For the last 15 to 20 years, medical devices in the EU have been governed by three directives:
• Medical Device Directive (MDD)
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• Active Implantable Medical Device Directive (AIMDD), which includes any device that
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• In Vitro Diagnostic Device Directive (IVDD)

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6,7

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and the electrical leads

clinipace.com

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