Healthcare Services

Global Medical Devices Vigilance Market Forecast Highlighting Expansion And Competitive Dynamics

June 1, 2026 by Marketing Posting

The Business Research Company’s 2026 market reports feature enhanced tools like market attractiveness analysis, TAM assessment, and company scoring matrices, along with interactive dashboards, deeper supply chain insights, and startup coverage strengthening the depth, usability, and strategic value of insights.

How Will The Market Value Of The Medical Devices Vigilance Market Change Between 2026 And 2030?

The medical devices vigilance market has experienced substantial growth in recent years. It is projected to expand from $97.66 billion in 2025 to reach $106.23 billion by 2026, demonstrating a compound annual growth rate (CAGR) of 8.8%. This historical growth can be attributed to several factors, including an increase in reported device-related adverse events, the implementation of post-market surveillance regulations, a rise in medical device usage, growing patient safety awareness, and the expansion of global regulatory frameworks.

The medical devices vigilance market is projected to experience substantial growth in the next few years. It is anticipated to reach $149.03 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 8.8%. This expansion in the forecast period is attributed to the proliferation of connected and complex medical devices, stricter post-market compliance requirements, an increase in cross-border device approvals, the rising adoption of proactive risk management, and the demand for continuous safety monitoring. Major trends during this period include strengthening post-market surveillance requirements, a growing focus on real-world evidence collection, increasing regulatory scrutiny on adverse event reporting, the expansion of global vigilance harmonization, and a growing demand for faster incident response mechanisms.

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Which Major Factors Are Contributing To The Development Of The Medical Devices Vigilance Market?

The expanding volume of medical recalls is anticipated to fuel the expansion of the medical device vigilance market. Medical recalls involve measures initiated by regulatory bodies, producers, or distributors to withdraw or amend medical items posing public health risks or failing to meet regulatory criteria. Medical device vigilance encompasses ongoing oversight of medical devices available in the market to detect adverse incidents, operational failures, or safety issues. Once identified, these are reported to regulatory bodies, which may trigger further scrutiny and, if necessary, a product withdrawal. For example, data from March 2024, shared by Sedgwick, a UK-based risk management and brand protection firm, indicated 3,306 medical device recalls occurred in Europe (EU + UK) during 2023, marking a 20% rise compared to 2022. Consequently, the rising frequency of medical recalls is stimulating the expansion of the medical device vigilance market.

What Segment Categories Are Evaluated In The Medical Devices Vigilance Market Study?

The medical devices vigilance market covered in this report is segmented –

1) By Delivery Mode: On-Demand, On-Premise

2) By Application: Therapeutics, Diagnostics, Surgical, Research, Other Applications

3) By End-User: Original Equipment Manufacturers (OEMs), Clinical Research Organizations (CROs), Business Process Outsourcing (BPO) Firms

Subsegments:

1) By On-Demand: Cloud-Based Solutions, Subscription Services, Remote Monitoring And Reporting

2) By On-Premise: In-House Software Solutions, Local Server Deployments, Customized System Implementations

What Trends Are Influencing The Future Of The Medical Devices Vigilance Market?

Leading companies in the medical device vigilance market are concentrating on innovations in post-market safety surveillance, specifically through artificial intelligence (AI)-driven modules designed to automate adverse event reporting, boost efficiency, and improve signal detection. Artificial intelligence (AI)-driven modules refer to intelligent software components that utilize artificial intelligence to process, analyze, and prioritize vigilance data to ensure regulatory compliance and patient safety. For instance, in July 2024, AB Cube, a medical software company based in France, introduced its upgraded customer vigilance platform to support the post-market monitoring of medical devices. This platform unifies adverse event reporting, trend analysis, and compliance documentation within a single interface; it operates by automating the collection, classification, and reporting of device-related incidents to regulatory authorities; distinct features include real-time analytics dashboards, automated regulatory submissions, and customizable alerts for critical safety events; its applications cover medical device manufacturers, notified bodies, and hospitals; the advantages comprise enhanced patient safety, reduced regulatory risk, quicker incident responses, and improved overall vigilance efficiency.

Who Are The Major Companies Operating In The Medical Devices Vigilance Market?

Major companies operating in the medical devices vigilance market are Johnson & Johnson, Intel Corporation, Oracle Corporation, Medtronic, Siemens Healthineers, RELX Group plc, MasterControl Inc., Laerdal Medical, Numerix, Smithers, Omnify Software Inc., Freyr, Sparta Systems, MDI Consultants Inc., Greenlight Guru, Jama Software, Sarjen Systems Pvt. Ltd, Arena Solutions Inc., Xybion Corporation, ZEINCRO Group, Extedo Gmbh, AssurX Inc., AB-Cube, Panacea Pharma Projects Limited, Qvigilance, General Electric (GE) Healthcare, Philips Healthcare, Baxter International, Stryker Corporation, Boston Scientific

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Which Region Accounts For The Highest Share Of The Medical Devices Vigilance Market?

North America was the largest region in the medical devices vigilance market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the medical devices vigilance market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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