Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

Analysis of data: “sufficient clinical evidence” Risk classifications

• animal tissues,

medicinal substances

How much data is enough data?

• invasive, longer term use, high risk anatomical locations, etc

• invasive, longer term use, high risk

• invasive, short term use, relatively low risk

• non-invasive, low-risk devices

The Organisation for Professionals in Regulatory Affairs

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The Facts – Class III and Implants

Class III Implants e.g. Coronary Stent

New Class III and Implantable Devices applying under MDR will require Clinical Investigations*

* Unless the device is a W.E.T, Legacy Device or modification of a device, or can successfully claim equivalence.

The Organisation for Professionals in Regulatory Affairs

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