Latest Articles
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MDCG 2025-5 Clarifies EU Rules for IVD Performance Studies Under IVDR
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.
Brazil’s UDI System Nears Enforcement: What Medical Device Manufacturers Must Know for 2025 and Beyond
Brazil’s Unique Device Identification (UDI) system is moving toward full enforcement, with mandatory labeling for Class IV devices starting July 10, 2025. This post breaks down the key requirements under RDC 591/2021 and RDC 884/2024, including SIUD database functions, labeling rules, and preparation steps for manufacturers.
ASEAN MedTech Import Market
Exploring the profound opportunities and increasing complexity in the Association of South-East Asian Nations medical technology import market from 2021-2024. The ASEAN MedTech import market presents significant opportunities amid increasing complexity. Analysis of export data from 2021-2024 reveals robust growth drivers despite top-line volatility. While demographic and economic trends signal sustained demand, aggregate import value fluctuated from $19.16 billion in 2021 to $18.34 billion in 2022, $17.79 billion in 2023, before rebounding to $19.26 billion in 2024.
5 Reasons EU device manufacturers should register in EUDAMED today
The European Commission has confirmed that key EUDAMED modules will become mandatory by Q3 2026 and manufacturers selling into the EU need to be ready. This article outlines five key reasons to prioritize EUDAMED registration now to avoid disruption, ensure compliance, and maintain market access.
Singapore HSA as a Gateway to Faster Device Registration in Key Markets
Singapore’s Health Sciences Authority (HSA) is now a globally recognized reference agency, offering manufacturers a fast track into key Asia-Pacific markets. This article explains how HSA approval can streamline registration in Thailand, Australia, and Hong Kong, and how its WHO Stringent Regulatory Authority status boosts access for high-risk IVDs. Leveraging HSA can cut costs, reduce timelines, and accelerate international expansion.
Wireless Compliance for Medical Device Manufacturers: Overview of Radio Frequency Module Integration
Manufacturers marketing a wireless medical device must consider communications authority regulations as well as medical device regulations. In this article, Michael Cassidy explains global market access requirements that manufacturers need to consider when integrating wireless module to their device.
How the EU IVDR opens doors beyond the EU
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.
Supply chain requirements for Economic Operators under the EU IVDR
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.
Clinical Evidence under IVDR: what is an “adequate level” for IVD manufacturers?
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.
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