The EU Commission recently published (January 23, 2024) a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring availability of safe devices that are essential for healthcare systems. With this...
Amending Regulation for MDR / IVDR: Key Takeaways for the Diagnostics Industry
Yesterday, the EU Parliament adopted the regulation amending EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring the availability of safe devices that are essential for healthcare systems. The amending regulation extends the transition...
2024 IVDR Sprint: 6 Reasons Why You Should Start a Performance Evaluation Early
In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European market, regardless of the device's risk class (Yes, even class A devices require a proper performance evaluation!). As...
Implications of FDA’s Quality Management System Regulation (QMSR) Final Rule
On February 2, 2024, the Food and Drug Administration (FDA) issued a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System Regulation (QSR). The final rule is effective February 2, 2026. The FDA plays a crucial...
The Role of Scientific/Medical Literature Screening and Review in Pharmacovigilance
Why search the scientific and medical literature? “Scientific and medical literature is a significant source of information for monitoring of the safety profile and of risk benefit balance of the medicinal products, particularly in relation to detection of new safety...
Key Insights from NMPA Guidance Draft 01 & 02 from Our Human Factors Team
The human factors team at Veranex has reviewed the NMPA Guidance Draft 01 and Draft 02 and submitted feedback to the agency. We're committed to helping you stay informed about the latest updates and clarifications in the ever-evolving regulatory landscape. Here's a...
Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA
In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss important deadlines, exceptions and the main differences in the way these tests will be overseen on these two continents.Please...
Webinar – 2024 IVDR Sprint Series: How to Adopt a Proactive Approach to Ensure Timely Compliance with the Applicable Deadlines
2024 IVDR Sprint How to Adopt a Proactive Approach to Ensure Timely Compliance with the Applicable Deadlines The In-Vitro Diagnostic (IVD) industry plays a pivotal role in modern healthcare by providing crucial information for patient management. In Europe, the...
Webinar: Panel Discussion – FDA’s Regulation on LDTs: Current Impact and Future
In this recorded panel discussion, members of different healthcare organizations discuss the potential impact of the FDA Rule on LDTs, near term / long term implications, and stakeholder’s priorities for minimal disruption. By watching this panel discussion, you will:...
Webinar – 2024 IVDR Sprint Series: Companion Diagnostics (CDx) – Critical Areas and Implications for Successful Development and Launch in the EU
In this recorded webinar, Amit Kumar Jain and Veronique Treil from Veranex share some of our first-hand industry expertise, helping you stay attuned to the latest industry developments, challenges and advancements specifically related to Companion Diagnostics and...