Table 3 Categorization of COVID-19 essential medical products according to EU and FDA legislation [35]
Type of medical product | EU classification | FDA classification | Description |
|---|---|---|---|
Mechanical ventilators | MD Class IIb | MD Class II | Medium- to high-risk devices, and patients may use them for a period longer than 30 days |
Personal protective equipment (PPE) | MD Class I | MD Class I | Low or moderate risk to patient’s health and safety not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human heal |
Diagnostic tests | IVD Class I | IVD Class I | No public health risk or low personal risk |