Medical Devices Vigilance Market Report 2025

This report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.

The medical devices vigilance market size has grown strongly in recent years. It will grow from $90.26 billion in 2024 to $97.94 billion in 2025 at a compound annual growth rate (CAGR) of 8.5%. The growth in the historic period can be attributed to growing awareness regarding medical device vigilance, growing awareness among the physicians and patients regarding the benefits of medical devices vigilance, rising pressure on medical devices manufacturers, increasing number of government initiative, and rising medical device usage.

The medical devices vigilance market size is expected to see strong growth in the next few years. It will grow to $137.61 billion in 2029 at a compound annual growth rate (CAGR) of 8.9%. The growth in the forecast period can be attributed to increasing launches of recall systems for medical devices, increasing number of post market surveillance programs for medical devices, increasing number of adverse events reported, increasing need for therapeutics and surgical procedures, and growing complexity related to patient safety regulations. Major trends in the forecast period include technological advancements, international medical device regulators forum (IMDRF) framework, enhances the exchange of safety information across borders, remote patient monitoring devices, 3D printing and personalized devices.

The increasing number of medical recalls is expected to propel the growth of the medical device vigilance market going forward. Medical recalls refer to the action taken by regulatory authorities, manufacturers, or distributors to remove or correct medical products that pose a risk to public health or do not comply with regulatory standards. Medical device vigilance entails continuous monitoring of medical devices in the market to identify adverse events, malfunctions, or safety concerns that, upon identification, are reported to regulatory authorities, potentially leading to further investigation and, if warranted, a product recall. For instance, in December 2022, the Food and Drug Administration (FDA), a US-based federal agency, observed a rise in medical device recalls, with 442 recalls documented in 2022, up from 331 in 2021, an almost 10% increase from 2021. Therefore, the increasing number of medical recalls is driving the growth of the medical device vigilance market.

Major companies operating in the medical device devices vigilance market are developing innovative products, such as quality management software, to improve customer satisfaction. Quality management software (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. For instance, in December 2022, Greenlight Guru, a US-based company providing systems and software to medical device companies, launched QMS software designed to help medical device companies modernize their processes, cut time from clinical testing, and bring safer products to market faster. Greenlight Guru's software is pre-validated per FDA and ISO best practices, aiming to help companies comply with the ever-changing standards. The company also offers training and certifications to help advance careers in product development, quality, and regulatory assurance.

In January 2024, GE Healthcare, a US-based medical technology company that offers a diverse portfolio of products, solutions, and services, acquired MIM Software Inc. for an undisclosed amount. The acquisition aims to reinforce GE HealthCare's digital strategy and enhance its imaging portfolio, particularly in medical device vigilance. MIM Software Inc. is a US-based company that provides services related to medical device surveillance through its specialization in medical imaging analysis and artificial intelligence (AI) solutions.

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.

North America was the largest region in the medical devices vigilance market in 2024. 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, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the medical devices vigilance market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The medical device vigilance market consists of revenues earned by entities by providing services such as adverse event reporting, post-market surveillance, risk management, quality management systems, and regulatory compliance. The market value includes the value of related goods sold by the service provider or included within the service offering. The medical device vigilance market also includes sales of data collection devices, communication devices, data storage and processing devices, medical imaging equipment, and wearable devices. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

Medical device vigilance refers to monitoring and reporting adverse events or incidents related to the use of medical devices. It is a critical component of post-market surveillance to ensure the safety and effectiveness of medical devices throughout their lifecycle. It identifies and addresses potential risks associated with medical devices, ensures patient safety, and maintains public trust in the healthcare system.

The main delivery modes of medical devices vigilance are on-demand and on-premise. On-demand medical device vigilance delivery mode refers to a system or approach where medical device vigilance services, such as monitoring, reporting, risk assessment, and communication related to adverse events or incidents with medical devices, are provided as needed or requested by healthcare providers, manufacturers, or regulatory authorities. It is used for therapeutics, diagnostics, surgical, research, and other applications by end-users such as original equipment manufacturers (OEMs), clinical research organizations (CROs), and business process outsourcing (BPO) firms.

The main delivery modes of medical devices vigilance are on-demand and on-premise. On-demand medical device vigilance delivery mode refers to a system or approach where medical device vigilance services, such as monitoring, reporting, risk assessment, and communication related to adverse events or incidents with medical devices, are provided as needed or requested by healthcare providers, manufacturers, or regulatory authorities. It is used for therapeutics, diagnostics, surgical, research, and other applications by end-users such as original equipment manufacturers (OEMs), clinical research organizations (CROs), and business process outsourcing (BPO) firms.

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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