Table 3.

Approximate costs related to the development of MDs (EUR).

		Inactive	Active		Active/implants		Comments
		I	I	IIa	IIb	III
Time of development [year]		1	1	2	2	2
Employees	HW	0	17,771	35,542	35,542	35,542	With a salary of 1,500EUR per month
	SW	0	17,771	35,542	35,542	35,542	With a salary of 1,500EUR per month
	other	35542	17,771	71,085	71,085	71,085	With a salary of 1,500EUR per month
Sterilization validation		0	0	1,851	1,851	1,851
Measurement validation		0	1,851	1,851	1,851	1,851
Tests el. Security		0	3,702	5,553	5,553	5,553	Not for implantable ones (joints, for stimulators)
EMC		0	1,851	3,702	3,702	3,702	EMC is not implantable (joints, it is a stimulator), but again they have a higher price for biological evaluation
Biological evaluation		1,851	1,851	5,553	5,553	5,553	Based on type of MD
Clinical evaluation		740	740	1,851	3,702	3,702	If the clinical trial is based on a clinical trial, even millions
Type test		740	740	3702	5,553	5,553
CE Conformity Declaration		0	0	7,405	9,256	11,107	Abroad: notified body: it is IIa - 20 thousand €; IIb - 25 thousand €, III - 30 thousand €, plus supervision every year about 5 thousand €. According to the MDR, it is expected that it should be up to 25% more.
QMS		5,553	5,553	5,553	5,553	5,553
PMCF		After placing a product on the market, the cost depends on the type of product, its use and the complexity of the study itself
		(large price range); estimate for IIb is part of the Appendix.
Total		44,428	69,604	17,9193	184,746	186,598