Table 4.
Adequacy of the available information and the respondent’s knowledge and expertise regarding the MDR, n = 74
| Information availability of the MDR | Agree | Neither agree nor disagree | Disagree |
|---|---|---|---|
| Sufficient information available regarding the MDR* | 74.3% (n = 55) | 1.4% (n = 1) | 24.3% (n = 18) |
| We know who to consult if our enterprise needs more information regarding the MDR | 83.8% (n = 62) | 1.4% (n = 1) | 14.9% (n = 11) |
| Based on the available information, we can identify the impact of the MDR on our enterprise’s operations | 83.8% (n = 62) | 6.8% (n = 5) | 9.5% (n = 7) |
| There is a website about the MDR that has all the information you need | 27% (n = 20) | 17.6% (n = 13) | 55.4% (n = 41) |
| Decision-making based on the information available is not an issue | 25.7% (n = 19) | 14.9% (n = 11) | 59.5% (n = 44) |
| Respondents’ knowledge and expertise regarding the MDR | |||
| I am familiar with the MDR in general | 93.2% (n = 69) | 5.4% (n = 4) | 1.4% (n = 1) |
| I know how the MDR affects the products that our enterprise makes | 93.2% (n = 69) | 4.1% (n = 3) | 2.7% (n = 2) |
| I have previous experience of the CE marking process for medical devices | 58.1% (n = 43) | 9.5% (n = 7) | 32.4% (n = 24) |
| I think that the available information is easy to understand | 35.1% (n = 26) | 8.1% (n = 6) | 56.8% (n = 42) |
*MDR = Medical Device Regulation.
Note: Percentages may not total 100% due to rounding or multiple responses.