Instruction about CE certification of detection reagents used for research
Cloud-Clone Corp.
CE mark is a kind of security authentication marks,considered as passport of a manufacturer to enter the European market. Not all products need CE certification. At present only 23 categories of products need CE certification and corresponding order number must be used on the certification (DERECTIVE). In vitro diagnostic medical devices use 98/79/EC DERECTIVE.
--------------------------------------------------------20, 98/79/EC, Medical devices: in vitro diagnostic medical devices----------------------------------------------------
Instructions: 98/79 / EC has clear rules: in vitro diagnostic medical devices and accessories in vitro diagnostic means medical devices used for in vitro test specimen from human (including blood and tissue). They can be any medical devices, reagents, reagent products, scaler, controlled substances, kits, equipment, instruments, equipment or system.
--------------------------------------------------------20, 98/79/EC, Medical devices: in vitro diagnostic medical devices----------------------------------------------------
Instructions: 98/79 / EC has clear rules: in vitro diagnostic medical devices and accessories in vitro diagnostic means medical devices used for in vitro test specimen from human (including blood and tissue). They can be any medical devices, reagents, reagent products, scaler, controlled substances, kits, equipment, instruments, equipment or system.
Directive 98/79 / EC is based on ISO13485 quality management system, providing a set of effective regulations. Before the CE certification, related products need to submit applications to the namely third parties to obtain independent certification to complete the performance evaluation procedures. Then registration at European management institutions is also needed, obtaining registration number which is necessary for CE mark.
Our company obtained the certification SGS iso13485:2008 n 2009. When there was no accurate understanding about directive 98/79 / EC, we entrusted a third party to apply CE certification for our samples from human and obtained CE certification. But the agency failed to submit the company's products to registered management institution. We stopped marking CE certification on any of our product after we fully understand the directive 98/79 / EC.
That is to say, although detection reagents used for research are defined as in vitro diagnostic reagents, they are not in vitro diagnostic medical devices and do not belong to the category of CE.