Essentials of European Medical Device Regulatory Affairs - October 2019

Module 4

• Classification of devices

• Classification rules

• Reclassification of devices

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Classification of Devices

More risky the product the higher the classification

• Class I

eg. tongue depressor

• Sterile • Measuring eg. dosing spoon

• Class IIA   • Class IIB  • Class III 

eg. blood pressure measuring

eg. ventilators eg. heart valve

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