DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices THE EUROPEAN PARLIAMENT AND THE COUNCIL OFTHE EUROPEAN UNION:

 

"(6) Whereas in vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection and attain the performance levels originally attributed to them by the manufacturer; whereas, therefore, maintenance or improvement of the level of health protection attained in the Member States is one of the main objectives of this Directive;"

 

From December 7th 2003 all in vitro diagnostic products placed on the EU market must, by directive of the European parliament and council of the European union, bear a CE label and consequently be registered in any member state.

 

A CE marked product is quality assured for consistent quality and performance over a long period of time. To qualify for CE marking the production must be stable and well controlled.

 

The control of the production includes testing of raw material and sub-contractors. All production batches are validated before release. The product's performance in clinic must be carefully quality monitored and documented.

 

The entire product development cycle and production process of ChromoQuant® is certificated in accordance with ISO13485-2003 and ISO 9001-2000.