Module 15 2022

19/05/2022

Class III and implantable devices

Exceptions applicable for new/legacy devices

Article 61 section:

Legacy Device

New Device

61.4 Equivalent (modification) to manufacturer’s own device 61.5 Equivalent to another manufacturer’s MDR device

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61.6a Already on the market under MDD/AIMD

x

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61.6b Listed device: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors

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

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

47

MDR compliance without clinical data article 61.10

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

48

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