Oliver Eikenberg, PhD
Dr. Oliver Eikenberg has almost three decades of expertise in the medical device sector, including 14 years in R&D, manufacturing, and quality control, and 15 years in medical device and IVD regulatory consulting.
About Oliver Eikenberg, PhD
His experience as a chemist, where he was managing the development of various immunoassays, lateral flow tests, and genetic tests, is the basis for his outstanding hands-on experience in writing or compiling all aspects of a Technical Documentation or FDA submission for a range of low- to high-risk IVDs, as well as medical devices. This includes deep IVD-specific expertise in companion diagnostics (CDx), in house IVD, and clinical performance study requirements under EU regulations. Dr. Eikenberg is also an expert in global medical device regulations and auditor for Quality Management Systems according to ISO 9001, ISO 13485, FDA QSR, and EU directives/regulations, such as the MDD, IVDD, MDR, IVDR. His expertise further covers strategic and regulatory compliance support for management level, such as for due diligence projects and customized training on medical device or QMS topics and regulations. Prior to joining Pure Global, Dr. Eikenberg was a Senior RA/QA Consultant, internal Auditor, and Lead IVDR Manager at Emergo by UL Solutions for 10 years. He holds a PhD in Biochemistry from the Technical University of Munich in Germany.
Latest Articles
Dr. Oliver Eikenberg breaks down the European Commission’s new MDCG 2025-5 guidance on IVD performance studies under the IVDR. He highlights how the document clarifies when studies require ethics and authority submissions, what qualifies as a substantial modification, and how to ensure data quality and compliance. For manufacturers and sponsors preparing for CE marking, these insights are essential to avoid costly delays and rejections.
Under the IVDR, European CE Marking requires more time and resources from IVD manufacturers than ever before. However, as more countries adopt the EU's approach to medical device and IVD regulation, IVD companies will find themselves well positioned to access other markets beyond the EU once their IVDR CE Mark is in place. In this article, Dr. Oliver Eikenberg discusses the potential to leverage IVDR CE Marking to streamline global market access.
Inadequate supply chain controls are a leading cause of non-conformities in Notified Body Technical Documentation Assessments under the IVDR. In this article, Dr. Oliver Eikenberg discusses how manufacturers should assess and update their supply chain agreements to ensure Economic Operator roles and obligations are clearly defined in line with IVDR requirements.
Conformity under the IVDR requires a rigorous approach to clinical evidence quality. In this article, Dr. Oliver Eikenberg explains the importance of performance evaluation processes and documentation to ensure adequate clinical evidence for EU IVDR compliance.
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.
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.
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.
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.
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.
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.
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.
Navigating the complexities of medical device recalls requires a robust management plan and clear communication strategies.