Table 5 Risk assessment of emergency use authorizations for PPE during the COVID-19 crisis
No. | Emergency use authorization measure | Consequence | Severity (1–4) | Probability (1–4) | Risk level (low, medium, high) |
|---|---|---|---|---|---|
1 | Import without CE mark and/or Declaration of conformity [41, 42] | Unknown manufacturer Unknown applied standards and directives Missing test results Responsible person | 3 | 3 | Medium |
2 | Product without national manufacturer representative | Longer procurement procedures | 3 | 3 | Medium |
3 | Fast approval of product | legal and health consequences | 1 | 4 | Low |