Table 2 Enterprise profiles, n = 74
The person responsible for regulatory compliance | % | n |
|---|---|---|
A person responsible for regulatory compliance in their enterprise | 81.1% | 60 |
A person permanently and continuously at their disposal | 18.9% | 14 |
Number of approved medical devices | ||
No devices approved | 13.5% | 10 |
One | 40.5% | 30 |
Two | 9.5% | 7 |
Three | 8.1% | 6 |
Four | 5.4% | 4 |
Five or more | 23% | 17 |
Type of medical device | ||
Software | 50% | 37 |
Devices | 50% | 37 |
Materials | 6.8% | 5 |
Instruments | 16.2% | 12 |
Classification of medical devices | ||
Class I (MDR*) | 36.5% | 27 |
Class Is (MDR) | 2.7% | 2 |
Class Im (MDR) | 1.4% | 1 |
Class Ir (MDR) | 0% | 0 |
Class IIa (MDR) | 36.5% | 27 |
Class IIb (MDR) | 10.8% | 8 |
Class III (MDR) | 2.7% | 2 |
Class I (MDD**) | 25.7% | 19 |
Class Is (MDD) | 1.4% | 1 |
Class Im (MDD) | 1.4% | 1 |
Class IIa (MDD) | 10.8% | 8 |
Class IIb (MDD) | 9.5% | 7 |
Class III (MDD) | 4.1% | 3 |
Our devices do not belong to the aforementioned classes | 1.4% | 1 |