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Table 6 Overall impact of the MDR, n = 74

From: Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals

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%

  1. *MDR = Medical Device Regulation.
  2. Note: Percentages may not total 100% due to rounding or multiple responses.