Table 5 Training, need for external support, reasons for outsourcing, n = 74

There has been sufficient training

55.4% (n = 41)

18.9% (n = 14)

25.7% (n = 19)

The trainers were competent

74.3% (n = 55)

17.6% (n = 13)

8.1% (n = 6)

The training has provided important information about the MDR

79.7% (n = 59)

17.6% (n = 13)

2.7% (n = 2)

I found the training sessions useful

78.4% (n = 59)

16.2% (n = 12)

5.4% (n = 4)

The content of the training sessions has been suitable for our enterprise

59.5% (n = 44)

27% (n = 20)

13.5% (n = 10)

The need for external expertise in the CE** marking process

We need the support of a medical device consultant in the CE marking process

73% (n = 54)

2.7% (n = 2)

24.3% (n = 18)

Our enterprise has the necessary expertise to carry out the CE marking process

75.7% (n = 56)

8.1% (n = 6)

16.2% (n = 12)

We receive support with the CE marking process from another health technology enterprise

36.5% (n = 27)

18.9% (n = 14)

44.6% (n = 33)

We independently learn all important aspects of the CE marking process

52.7% (n = 39)

14.9% (n = 11)

32.4% (n = 24)

Reasons to outsource parts of the CE marking process

Cost savings

21.6% (n = 39)

27% (n = 20)

51.4% (n = 38)

Because of the allocation of resources

74.3% (n = 55)

10.8% (n = 8)

14.9% (n = 11)

Lack of necessary knowledge and expertise in our enterprise

82.4% (n = 61)

8.1% (n = 6)

9.5% (n = 7)

It is not possible to acquire your own expertise

31.1% (n = 23)

25.7% (n = 19)

43.2% (n = 32)

Our enterprise does not need to outsource the CE marking process

47.3% (n = 35)

27% (n = 20)

25.7% (n = 19)