Table 7.
ICT systems and performance of Fimea regarding the MDR, n = 74
| ICT systems in the MDR (e.g., EUDAMED*, NANDO**) are useful | Agree | Neither agree nor disagree | Disagree | ||
|---|---|---|---|---|---|
| Enterprise size | Micro | n | 17 | 10 | 7 |
| % | 50% | 29.4% | 20.6% | ||
| Small | n | 14 | 9 | 3 | |
| % | 53.8% | 34.6% | 11.5% | ||
| Medium-sized | n | 3 | 3 | 2 | |
| % | 37.5% | 37.5% | 25% | ||
| Large | n | 4 | 2 | 0 | |
| % | 66.7% | 33.3% | 0% | ||
| The regulatory authority (Fimea) has performed its duties well in the MDR*** | |||||
| Enterprise size | Micro | n | 10 | 10 | 14 |
| % | 29.4% | 29.4% | 41.2% | ||
| Small | n | 6 | 8 | 12 | |
| % | 23.1% | 30.8% | 46.2% | ||
| Medium-sized | n | 1 | 2 | 5 | |
| % | 12.5% | 25% | 62.5% | ||
| Large | n | 1 | 2 | 3 | |
| % | 16.7% | 33.3% | 50% | ||
EUDAMED = European Database on Medical Devices.
**NANDO = New Approach Notified and Designated Organisations.
***MDR = Medical Device Regulation.
Note: Percentages may not total 100% due to rounding or multiple responses.