Latest News for: ivdr

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Simplifying MDR and IVDR (Cuatrecasas, Gonçalves Pereira SLP)

Public Technologies 26 Jan 2026
However, for some years now, a review and simplification of the MDR and IVDR has been in the works ... If adopted in the terms proposed, the "new MDR/IVDR" will be easier to navigate for actors operating in the health technology sector.
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EU (European Union) and UK Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) ...

Business Wire 16 Jan 2026
... Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR), adopted in May 2017.
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EU (European Union) and UK Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) Update Training Course (Online Event: April 29, 2026) - ResearchAndMarkets.com

Pharmiweb 16 Jan 2026
Stay informed on the significant changes since the adoption of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR), adopted in May 2017.
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DNV supports NOUL in IVDR certification for AI-based diagnostic devices (DNV AS)

Public Technologies 14 Jan 2026
The EU's IVDR provides a regulatory basis for establishing the safety and effectiveness of new in-vitro diagnostic (IVD) devices. Most IVD devices require a certificate of compliance with the IVDR to receive a CE mark that allows their sale in the EU.
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MedTech Europe submission to the European Commission’s Call for Evidence consultation on the MDR/IVDR simplification reform (MedTech Europe)

Public Technologies 12 Jan 2026
IVDR/MDR must be designed with sufficient flexibility to be future-proof and to remain coherent with current and future horizontal EU laws ... Act and the IVDR/MDR which can be completed in a timely way.
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The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device ...

The Galveston Daily News 30 Dec 2025
DUBLIN--(BUSINESS WIRE)--Dec 30, 2025-- ....
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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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