NeoSickle makes a successful transition to the new IVD regulations
Biomaneo's first IVDR CE-certified product
Biomaneo obtains IVDR certification of CE conformity under Regulation (EU) 2017/746 for its NeoSickle device. The EU Quality Management System certificate - Regulation (EU) 2017/746, Annex IX Chapters I and III - was delivered by Biomaneo's notified body, GMED, on 7 September 2023 under the following scope :
"Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease".
NeoSickle solutions are class C in vitro diagnostic medical devices, intended for the screening, by mass spectrometry, of major sickle cell syndrome or sickle cell trait, by detecting the presence of the "S" mutated beta haemoglobin (Hb) chain and/or an absence of the "A" non-mutated beta haemoglobin chain from dried blood samples. These solutions are used in combination with the eNeoSickle software.
This certification, which meets stringent new European standards, reflects Biomaneo's determination to strengthen its quality management system, which has been in place for several years, and sends a strong signal to its customers about the performance and reliability of its medical devices.
This is an important step in the development of future products for Biomaneo, which became a subsidiary of the Shimadzu Group in May 2023. Biomaneo is thus reinforcing the Group's regulatory expertise, a major asset for the marketing of new screening and diagnostic products.