By Dr. Nathalie Le Bastard, Nathalie Dekeersmaeker and Jolien Roelens, Fujirebio Europe
The European CE-marking is used to support registrations of in vitro diagnostic (IVD) medical devices in many jurisdictions around the world. The European Union Directive on In Vitro Diagnostic Medical Devices (98/79/EC; IVDD) that sets out the guidance for CE-marking of IVD products was replaced by a new regulation EU/2017/746 as of May 2022 (IVD Regulation). This update of the European regulatory system brings about several changes to the information provided with IVD devices and their regulatory documentation. The regulatory documentation includes changes to labelling, notified body certificates, and declarations of conformity. This update however does not impact the device itself i.e., it does not imply changes to the composition or the manufacturing process of the device, and the performance and safety characteristics remain the same.
According to the new IVDR classification, the Fujirebio LUMIPULSE G1200 and G600II instruments as well as their common reagents are classified as Class A products and have been IVDR-certified since May 2022. The Declaration of Conformity for those items can be found here (for LUMIPULSE G1200) and here (for LUMIPULSE G600II).
The entire range of Lumipulse G CSF AD biomarker assays (β-Amyloid 1-42, β-Amyloid 1-40, Total Tau and pTau 181) available in Europe has been classified as Class B and has also been gradually IVDR-certified between June and August 2022. The Declaration of Conformity can be found here (the present markers fall under Class B – W0102 – IVR0601), and notification to the Belgian competent authorities by Fujirebio Europe, as the EC rep of Fujirebio Inc. (Japan), has been done prior to placement on the European market. All items (immunoreaction cartridges, calibrators and controls) of the Lumipulse G CSF AD biomarker portfolio have already been placed on the market under the new IVD(R) label. Below mentioned table gives an overview of the applicable products.
|230336||Lumipulse G β-Amyloid 1-42 Immunoreaction Cartridges|
|231524||Lumipulse G β-Amyloid 1-40 Immunoreaction Cartridges|
|230312||Lumipulse G Total Tau Immunoreaction Cartridges|
|230350||Lumipulse G pTau 181 Immunoreaction Cartridges|
|230343||Lumipulse G β-Amyloid 1-42 Calibrators set|
|231531||Lumipulse G β-Amyloid 1-40 Calibrators set|
|230329||Lumipulse G Total Tau Calibrators set|
|230367||Lumipulse G pTau 181 Calibrators|
|231548||Lumipulse β-Amyloid Controls|
|230237||Lumipulse Total Tau Controls|
|230220||Lumipulse pTau 181 Controls|
Our INNOTEST range of CSF AD biomarker assays is in process of being IVDR-certified. The deadline for IVDR certification, imposed by the IVD Regulation for these class B products, is May 26th, 2027. We will communicate further on this upon completion.