Guidance for In-vitro Diagnostic Medical Device application for CE mark
LING Ben-suo UL-CCIC Company Limited (Guangzhou 510030)
Directive 98/79/EC for In-vitro Diagnostic Medical Device (IVDD) came to be mandatory on Dec 2003 in European Communities. All In-vitro Medical Devices, other than devices for performance evaluation must bear the CE marking of conformity when they are placed on the market. Member States shall accept the placing on the market of devices which conform to the rules in force in their territory on the date on which this Directive enters into force. This document provides guidance on In-vitro Diagnostic Medical Device application for CE mark. It provides a step-by-step procedure to help manufacture how to do.