Latest News for: ivdr

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BD Expands BD MAX™ System Menu with New IVDR-Certified VIASURE Assays in Partnership with Certest Biotec

The Galveston Daily News 15 Dec 2025
FRANKLIN LAKES, N.J., Dec.
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EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) Training Webinar: Explore Impact ...

Nasdaq Globe Newswire 05 Nov 2025
The evolving EU MDR and IVDR present key opportunities for companies to enhance compliance strategies, engage with ...
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Recertification under the MDR and IVDR – Frequently Asked Questions (MedTech Europe)

Public Technologies 05 Nov 2025
Re-certification under the MDR and IVDR ... Under the EU Medical Devices Regulation ("MDR", 2017/745) and the In Vitro Diagnostic Medical Devices Regulation ("IVDR", 2017/746), certificates are valid for five years.
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BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD ...

Citizen Tribune 03 Nov 2025
FRANKLIN LAKES, N.J., Nov.
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BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR™ System

PR Newswire 03 Nov 2025
FRANKLIN LAKES, N.J., Nov. 3, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE ... Continue Reading. BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR™ System ... (V ... Contacts. ... .
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Why SGS for Your IVDR Compliance (SGS SA)

Public Technologies 17 Oct 2025
In a world with few In Vitro Diagnostic Medical Device Regulation (IVDR) Notified Bodies (NBs), we stand ready to fast-track your application and entry to the EU market ... The IVDR regulates in vitro diagnostic medical devices placed on the EU market.
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CareDx Announces New IVD Products and IVDR Certification for AlloSeq® Tx and QTYPE® at the ...

The Galveston Daily News 06 Oct 2025
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct 6, 2025-- ....
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CareDx Announces New IVD Products and IVDR Certification for AlloSeq® Tx and QTYPE® at the 2025 American Society of Histocompatibility & Immunogenetics Annual Meeting

Pharmiweb 06 Oct 2025
The company also announced that its AlloSeq® Tx and QTYPE® products have received certification for compliance to the In Vitro Diagnostic Regulation (IVDR) in the European Union ... IVDR Product Certifications.
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