Global Regulatory Update: IMDRF Strengthens International Cooperation in Medical Device Regulation
Overview The International Medical Device Regulators Forum (IMDRF) continues its mission to harmonise and strengthen global medical device regulations. By accelerating international regulatory convergence, IMDRF aims to build a more efficient, effective, and responsive global regulatory model—one that keeps pace with rapid technological innovation while ensuring public health and safety. 28th IMDRF Management Committee Meeting […]
CDSCO’s New Provision on Subsequent Importers: What Medical Device Companies Need to Know
Introduction The Central Drugs Standard Control Organisation (CDSCO) has recently updated its regulatory framework to streamline the role of subsequent importers of medical devices in India. This move directly impacts manufacturers, authorized representatives, and distributors who rely on multiple import partners. At Bioexcel, we’ve broken down what this new provision means, why it matters, and […]
MDCG 2025: The New Era of Vigilance & Trend Reporting for Medical Devices
Introduction The European regulatory landscape is evolving once again. With the upcoming MDCG 2025 guidance, medical device manufacturers face a major shift in how post-market vigilance is managed. Trend reporting — once seen as optional or secondary — is now a mandatory requirement. This change will fundamentally reshape how manufacturers track, analyse, and report device […]
AI in Clinical Trials for Medical Devices: What’s New in 2025
Clinical trials for medical devices are undergoing a transformation thanks to artificial intelligence (AI). From designing smarter studies to speeding up patient enrolment and crunching vast datasets, AI is helping device makers and researchers conduct trials more efficiently and adaptively. This post explores how AI is being applied in trial design optimisation, patient recruitment, data […]
Common Clinical Trial Pitfalls That Delay CE Marking—and How to Avoid Them
Introduction: Achieving CE Marking for a medical device under the EU MDR is challenging even when everything goes right. Unfortunately, there are common pitfalls in the clinical trial and evidence development process that can derail or delay your CE Mark submission. Many manufacturers have faced questions, requests for additional data, or outright refusals from notified […]
From Idea to Approval: What Sponsors Must Know Before Their First Trial
Introduction: The journey from a bright medical device idea to an approved product on the market is exciting – but it can be daunting for first-time sponsors. Before launching your first clinical trial, there are critical things you need to know and prepare. A clinical trial is not just an experiment; it’s a highly regulated […]
Navigating IVDR & WHO TSS-1 Compliance for In Vitro Diagnostic Devices
Your Complete Guide to EU Market Access & Global Quality Standards In Vitro Diagnostic Medical Devices (IVDs) are essential tools in modern healthcare — enabling disease detection, treatment monitoring, and population screening. Under Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation, or IVDR), IVDs are defined as devices intended by the manufacturer to be […]
How to Justify Sample Size in Medical Device Trials
Introduction Determining the right sample size is a critical step in designing any clinical trial, and medical device studies are no exception. How many patients do we need? is not just a statistical question – it’s a regulatory and ethical one as well. Regulators expect sponsors to justify their sample size with a solid scientific […]
Human Factors in Clinical Trials: Bridging Usability & Safety
Introduction When testing a new medical device, ensuring it is not only effective but also usable and safe in the hands of real-world users is paramount. Human factors (HF) engineering – sometimes called usability engineering – focuses on how people interact with devices, aiming to minimise use errors and enhance user experience. Bridging human factors […]
ISO 14155:2020 Demystified — Designing Compliant Clinical Investigations
Introduction Within the field of medical device trials, ISO 14155:2020 serves as the definitive guideline for Good Clinical Practice (GCP). This international standard, titled “Clinical investigation of medical devices for human subjects – GCP”, demystifies what it takes to design and conduct device trials that meet ethical and scientific quality benchmarks. For sponsors and Clinical […]
