Table 5.
Training, need for external support, reasons for outsourcing, n = 74
| Views on training concerning the MDR* | Agree | Neither agree nor disagree | Disagree |
|---|---|---|---|
| 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) |
*MDR = Medical Device Regulation.
**CE = Conformité Européenne.
Note: Percentages may not total 100% due to rounding or multiple responses.