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. 2023 Mar 30;23:310. doi: 10.1186/s12913-023-09316-8

Table 6.

Overall impact of the MDR, n = 74

The MDR* has improved product traceability Agree Neither agree nor disagree Disagree
Enterprise size Micro n 23 9 2
% 67.6% 26.5% 5.9%
Small n 21 3 2
% 80.8% 11.5% 7.7%
Medium-sized n 4 3 1
% 50% 37.5% 12.5%
Large n 6 0 0
% 100% 0% 0%
The MDR has improved patient safety
Enterprise size Micro n 23 4 7
% 67.6% 11.8% 20.6%
Small n 20 3 3
% 76.9% 11.5% 11.5%
Medium-sized n 5 3 0
% 62.5% 37.5% 0%
Large n 6 0 0
% 100% 0% 0%
The MDR has increased transparency
Enterprise size Micro n 21 8 5
% 61.8% 23.5% 14.7%
Small n 22 1 3
% 84.6% 3.8% 11.5%
Medium-sized n 3 3 2
% 37.5% 37.5% 25%
Large n 5 0 1
% 83.3% 0% 16.7%
The MDR guarantees fair market access for enterprises
Enterprise size Micro n 13 6 15
% 38.2% 17.6% 44.1%
Small n 10 5 11
% 38.5% 19.2% 42.3%
Medium-sized n 3 3 2
% 37.5% 37.5% 25%
Large n 5 1 0
% 83.3% 16.7% 0%

*MDR = Medical Device Regulation.

Note: Percentages may not total 100% due to rounding or multiple responses.