Table 4 Adequacy of the available information and the respondent’s knowledge and expertise regarding the MDR, n = 74

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)