The Medical Devices Introductory Course 2020

Conclusions

Borderline Products always interesting and not always straightforward ● Based on intended purpose and scientific data to support mode of action ● Has to be assessed on a case by case basis ● Classification may differ between Member States Be aware of MDR impacts ● Rule 14 wording change ● Inclusion of some product without a medical purpose Classification of a product has huge impact on...........

The Organisation for Professionals in Regulatory Affairs

Learning Objectives for this presentation were:

What is and what is not a medical device MDD Vs MDR Definitions Classification rules and guidance – MDD Vs MDR How to determine product classification & its importance Borderline cases How combinations of drug and devices are regulated

The Organisation for Professionals in Regulatory Affairs