Latest Articles
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Engaging a Notified Body under the IVDR: What legacy manufacturers need to know about the pre-application process
The IVDR transition includes structured processes IVD manufacturers must follow to engage with Notified Bodies. Many IVD manufacturers are interacting with Notified Bodies for the first time and must understand what is required to ensure a successful partnership. In this article, Dr. Oliver Eikenberg clarifies what manufacturers must prepare and when to engage a Notified Body for IVDR CE Marking.
Regulatory requirements and challenges for new and old Class D devices under IVDR
Class D IVD manufacturers face fast-approaching IVDR transition deadlines, though some are more familiar with the regulatory process. In this article, Dr. Oliver Eikenberg discusses the difference between "new" and "old" Class Ds, and regulatory logistics they need to consider during the transition process.
Intended purpose for IVDs and impact on the classification under IVDR
Your IVD's intended purpose determines its classification, clinical evidence requirements, and clinical applications under the IVDR. Device companies will need a more robust intended purpose to fulfill IVDR criteria. In this article, Dr. Oliver Eikenberg explains the role of the intended purpose in IVDR compliance.
Why and How EU IVDR Compliance Matters before the May 2025 Deadline
Many IVD and legacy IVD device manufacturers are obligated to comply with certain aspects of the IVDR even before their transition deadline. In this article, Oliver Eikenberg discusses how IVD companies can maintain EU compliance during the transition period.
Adapting your QMS to IVDR requirements until May 2025: what manufacturers need to know
The official IVDR transition period is here. IVDR expert Dr. Oliver Eikenberg discusses how IVD manufacturers should take action, starting with how to implement IVDR QMS requirements for the May 2025 deadline.
MDA Updates at IMDEC 2024: Paving the Way for Regulatory Excellence and Innovation in Medical Technology
Pure Global participated in IMDEC 2024 in Kuala Lumpur to discuss the latest advancements in medical technology, regulatory efficiency, and the role of AI in transforming the industry. Highlights included updates from the Malaysian Medical Device Authority (MDA) that showcased their commitment to driving regional leadership in medical device regulation and innovation.
Pure Global 2024: A Year of Growth, Innovation, and Global Impact
As 2024 comes to a close, Pure Global proudly reflects on a transformative year marked by substantial growth, cutting-edge innovation, and impactful collaborations.
What are the challenges under IVDR?
IVD manufacturers cite the new classification system, detailed definitions for intended purposes, and the need for verification of clinical evidence as key challenges under the IVDR.
The EU Parliament votes on a resolution to revise specific parts of the MDR and IVDR
On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.
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