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Medical Device Development Service - Medical Device Certification Services
STEMart - Notified Body (EU) Services
CE marking is the manufacturer`s declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In Vitro Diagnostics Directive (IVDD) 98/79/EC, which outline the safety and performance requirements for active medical electrical equipment, non-active medical devices, and in vitro diagnostic medical devices. In order to place a medical device on the European market, manufacturer must obtain a CE mark.