Module 18 2021

2/9/2021

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.

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Equivalence Reminder:

Note: Access to Data Requirements under MDR!

 

Y

Example:

Clinical data sufficient ?

Y

Equivalence demonstrated ?

Subject device

N



N

Claimed equivalent

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