The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted.
Usklađenost medicinskih proizvoda i in vitro dijagnostičkih proizvoda s odredbama 93/42/EEC, 90/385/EEC i 98/79/EEC mora biti provjerena prije puštanja proizvoda u prodaju.