IVDR Performance Evaluation: NB Review Explained
Introduction: Why Performance Evaluation Is Where IVDR Decisions Are Made Many IVD manufacturers assume that once performance studies are completed, regulatory approval is largely procedural. Under IVDR, this assumption is risky. In practice, Notified Bodies make their most critical decisions during performance evaluation review. This is where scientific validity, analytical performance, and clinical performance are […]
India’s Medical Device Industry Scheme
Introduction: A Game-Changer for India’s MedTech Sector The Indian government’s Scheme for Strengthening of the Medical Device Industry is a landmark initiative designed to boost domestic manufacturing, cut import dependence, and promote clinical evidence generation across the medical device ecosystem. pharmabiz.com With an allocated outlay of ₹500 crore, the scheme supports key industry bottlenecks from […]
Why IVDR Performance Studies Fail During Review
Introduction: When Study Completion Isn’t the Finish Line For many IVD manufacturers, completing a performance study feels like crossing a major regulatory milestone. Budgets are spent. Timelines are met. Internal teams move on to the next priority. Yet during IVDR conformity assessment, Notified Bodies frequently raise new questions sometimes requesting additional data, re-analysis, or even […]
Clinical Trials for Medical Devices Under EU MDR
Introduction: Why Clinical Trials Have Become a Bottleneck for CE Marking For many medical device manufacturers, CE marking under the EU MDR has become slower, costlier, and far more uncertain than under the old MDD. One reason stands out: clinical evidence expectations have fundamentally changed. https://bioexcelife.com/ Devices that previously relied on literature, equivalence, or post-market […]
MDCG 2025-9: EU Guidance on Breakthrough Devices
In 2025, the Medical Device Coordination Group (MDCG) released MDCG 2025-9, a new guidance introducing a structured EU framework for Breakthrough Devices (BtX) under EU MDR (2017/745) and IVDR (2017/746). EU MDCG Guidance Page This guidance is a major step toward supporting innovative, high-impact medical devices, while still maintaining strong safety and clinical evidence requirements. […]
India’s New CDSCO Risk Classification Update
The Central Drugs Standard Control Organisation (CDSCO) has released a new circular announcing the launch of the Risk Classification Module on the Online Medical Device System (OMDS). https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM2Njc= This update is an important step toward making India’s medical device regulatory framework more transparent, predictable, and aligned with MDR 2017. What Is the Risk Classification Module? […]
EUDAMED 2026 Compliance Guide for Manufacturers
On 27 November 2025, the European Commission officially announced that four EUDAMED modules are now fully functional and will become mandatory for use on 28 May 2026. https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_enThis change, published in Commission Decision (EU) 2025/2371, therefore marks a major turning point in EU MDR regulation, and it will greatly impact how manufacturers prepare for compliance […]
Materiovigilance Compliance Guide for India
India’s medical device industry is growing rapidly, but with growth comes a greater responsibility to protect patients and ensure ongoing device safety. Under the Medical Device Rules (MDR) 2017, all manufacturers must maintain a robust Post-Market Surveillance (PMS) system and comply with materiovigilance requirements. The Materiovigilance Programme of India (MvPI)—run by the Indian Pharmacopoeia Commission […]
Avoiding Costly Delays: Common Pitfalls in Design Verification
Design verification is one of the most critical steps in medical device development — and one of the most misunderstood. Even seasoned manufacturers face setbacks during this stage, leading to rework, timeline extensions, budget overruns, and regulatory delays. Understanding and avoiding these pitfalls can save months of effort and significantly increase your chances of a […]
From Concept to Compliance: Step-by-Step Guide to Verification Planning
Verification planning is the foundation of compliant medical device design. It starts the moment design inputs are defined and continues through every phase—ensuring that what’s built aligns with regulatory requirements, user needs, and patient safety. A structured verification plan transforms product development from trial-and-error to a traceable, risk-controlled process — essential for CE marking, FDA […]
