Table 2.

Enterprise profiles, n = 74

The person responsible for regulatory compliance	%	n
A person responsible for regulatory compliance in their enterprise	81.1%	60
A person permanently and continuously at their disposal	18.9%	14
Number of approved medical devices
No devices approved	13.5%	10
One	40.5%	30
Two	9.5%	7
Three	8.1%	6
Four	5.4%	4
Five or more	23%	17
Type of medical device
Software	50%	37
Devices	50%	37
Materials	6.8%	5
Instruments	16.2%	12
Classification of medical devices
Class I (MDR*)	36.5%	27
Class Is (MDR)	2.7%	2
Class Im (MDR)	1.4%	1
Class Ir (MDR)	0%	0
Class IIa (MDR)	36.5%	27
Class IIb (MDR)	10.8%	8
Class III (MDR)	2.7%	2
Class I (MDD**)	25.7%	19
Class Is (MDD)	1.4%	1
Class Im (MDD)	1.4%	1
Class IIa (MDD)	10.8%	8
Class IIb (MDD)	9.5%	7
Class III (MDD)	4.1%	3
Our devices do not belong to the aforementioned classes	1.4%	1

*MDR = Medical Device Regulation

**MDD = Medical Device Directive

Under the MDR and MDD, Class I medical devices are low-risk devices, while Class III medical devices are high-risk devices.

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