Latest News for: ivdr

Edit

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.
Edit

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.
Edit

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.
Edit

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.
Edit

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-- ....
Edit

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.
Edit

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 ...
Edit

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.
Edit

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.
Edit

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. ... .
Edit

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.
  • 1

Article Search

tools
×
×
×
×