Qassay’s innovative lateral flow reader has earned the CE mark, signifying its compliance with European safety and performance standards. This paves the way for commercialization within the European Union.
Quality and Regulatory Compliance
“Obtaining CE marking is another step in Qassay’s design and consolidation as a high-quality device offering innovative solutions to real people’s problems.”
CE marking indicates that the product complies with safety, health, and environmental standards established by European Union legislation. This includes the Regulation (EU) 2017/746 (IVDR), which sets out essential safety and performance requirements for in vitro diagnostic medical devices.
About CE Marking
CE marking (Conformité Européenne) is a legal requirement for many products sold within the European Economic Area (EEA), which includes the European Union, Iceland, Liechtenstein, and Norway. ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation (EU) 2017/746 (IVDR) and other applicable Union harmonisation legislation providing for its affixing.
