Atossa Genetics announced it has received certification to Annex II of the European Medical Device Directive (MDD) from its European Notified Body, DQS Medizinprodukte GmbH, which allows Atossa to place the "CE" Mark on the ForeCYTE Breast Aspirator for distribution in the European Union and its member states.
DQS Medizinprodukte GmbH, a Notified Body/Registrar, is also a participant in the FDA’s third-party inspection program.
MDD certification verifies that the ForeCYTE Breast Aspirator device meets all applicable directives and standards applicable for its device classification per the directive and has been evaluated and meets the requirements outlined in Annex I, Essential Requirements of the directive.
The ForeCYTE Breast Aspirator device is a reusable, hand-held pump device intended for the collection of a small amount of nipple aspirate fluid (NAF) from a woman’s breast for cytological testing (not available in the U.S.).
The granting of this "CE" mark involved a comprehensive audit of the company’s quality system as well as a thorough evaluation of the ForeCYTE Breast Aspirator overall design to assure it performs safely.
"This approval marks an essential pivot point for Atossa as we pursue commercialization of the ForeCYTE Breast Aspirator into various European markets," said Steven C. Quay, Chairman, CEO & President of Atossa. "We are very pleased to attain this important certification as the "CE" mark validates our capability to manufacture and develop a device that meets the applicable regulatory requirements for the European Union," he continued.