Module 18 2021

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2/9/2021

Pre- Clinical Data

High Quality Clinical Investigations

The Grey Zone

The boundaries of MDR have been set!

What about those devices in-between?

• Class IIa/IIb devices where clinical trial data is not feasible?

• Class III devices with no available data e.g. Accessories ?

Our device performs as intended as we have only 1% of complaints

Absence of evidence is not evidence of absence.

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