By Your Side Through IVDR
The European In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 came into effect on 26 May 2017 and replaces the European In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC. A global cross-functional team at BD Biosciences has been working to implement the new regulation in a seamless and compliant manner.
EU IVDR Amending Regulations (EU) 2022/112 and (EU) 2023/607 expands the scope of the grace period to certain devices and the abolishment of the sell-off provisions of IVDR. Consequently, devices placed on the market before the end of the transition period can be made further available on the market without a time restriction.
We are committed to providing IVDR compliant solutions to continue delivering safe and effective IVD medical devices to serve you and your patients. We received our first IVDR product certification back in December 2020 and the majority of BD's previous IVDD compliant devices for flow cytometry are now IVDR compliant. We are continuing our efforts to achieve this for current and new products in our clinical portfolio.
The BD Biosciences IVDR compliant reagent portfolio includes in vitro diagnostic solutions for*
- Flow cytometric immunophenotyping of haematological disorders.
- Monitoring human immunodeficiency virus (HIV)–infected individuals.
- Characterising and monitoring immunodeficiency and autoimmune diseases.
- Cell enumeration of blood products for transfusion and stem cell transplantation procedures.
The BD Biosciences IVDR portfolio will also include flow cytometers and automation solutions.
*After the IVDR date of application, the products indicated on this page will be made available as IVDR compliant devices and/or as IVDD compliant devices
Read More about IVDR Article 5.5 and Upcoming Changes for LDT
Read More
Key IVDR Article 5(5) milestones; impact to laboratories
BD FACSLyric™ Flow Cytometer with the BD FACSuite™ Clinical and BD FACSuite™ applications, BD FACSDuet™ Sample Preparation System, BD FACSDuet™ Premium Sample Preparation System, BD Multitest™ Reagents (333184, 333185 only) and BD FACS™ Lyse Wash Assistant are in vitro diagnostic medical devices bearing a CE mark.
BD OneFlow™ PCST, BD OneFlow™ PCD, BD OneFlow™ LST, BD OneFlow™ B-CLPD T1, BD OneFlow™ ALOT, BD Multitest™ Reagents (except 333184, 333185), BD® Multi-Check Control, BD® Multi-Check CD4 Low Control, BD® Stem Cell Enumeration Kit, BD® Stem Cell Control, BD Trucount™ Tubes, BD Leucocount™ Kit , BD Leucocount™ Control (RBC, PLT and Combo) and the BD Single-Color Reagents (linked document) are in vitro diagnostic medical devices bearing a CE mark and are CE certified by BSI Group The Netherlands B.V. (Notified Body Number = 2797).
After the IVDR date of application, the products indicated on this page will be made available as IVDR compliant devices and/or as IVDD compliant devices.
BD Flow Cytometers, BD FACSDuet™ Premium Sample Preparation System and BD FACSDuet™ Sample Preparation System are Class 1 Laser Products.
- van Dongen JJM, Lhermitte L, Böttcher S, et al. on behalf of the EuroFlow Consortium (EU-FP6, LSHB-CT-2006-018708). EuroFlow antibody panels for standardized n-dimensional flow cytometric immunophenotyping of normal, reactive and malignant leukocytes. Leukemia. 2012;26(9): 1908-1975. doi: 10.1038/leu.2012.120
- van der Velden VHJ, Flores-Montero J, Perez-Andres M, et al. Optimization and testing of dried antibody tube: The EuroFlow LST and PIDOT tubes as examples. J Immunol Methods. 2019;475:112287. doi: 10.1016/j.jim.2017.03.011
- Moloney E, Watson H, Barge D, et al. Efficiency and health economic evaluations of BD OneFlow™ Flow Cytometry Reagents for diagnosing chronic lymphoid leukemia. Cytometry B Clin Cytom. 2019;96(6):514-520. doi: 10.1002/cyto.b.21779
EuroFlow or any of the EuroFlow participants cannot be held liable for any claims or damages in connection with their services in the field of flow cytometry.