Essentials of European Medical Device Regulatory Affairs

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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Classification – Key Concepts

Rules apply according to intended purpose - :

Duration:

transient (<60 mins) short term (<30 days) long term (>30 days)

Invasiveness:

Non-invasive invasive in a body orifice (eyes/stoma) surgically invasive implantable (hip replacement)

Non-Active/Active:

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