May 26, 2024

Medical Devices Vigilance Market Size, Share, Report by 2033

The global medical devices vigilance market size reached USD 80.40 billion in 2023 and is projected to attain around USD 176.80 billion by 2033, growing at a CAGR of 8.19% from 2024 to 2033.

Key Points

  • The North America medical devices vigilance market size reached USD 24.12 billion in 2023 and is expected to attain around USD 53.04 billion by 2033.
  • North America was estimated to hold a substantial market share of 34% in 2023.
  • Asia Pacific is projected to witness rapid growth in the global market.
  • By delivery mode, the on-demand segment accounted for the largest share of 81% in 2023.
  • By delivery mode, the on-premises segment is expected to have steady growth over the forecast period.
  • By application, the diagnostics segment held a substantial market share of 36% in 2023.
  • By application, the research segment is expected to show lucrative growth over the forecast period.
  • By end use, the clinical research organization segment held the highest market share of 42% in 2023.
  • By end use, the business process outsourcing firms segment is expected to grow rapidly in the foreseeable period.

Medical Devices Vigilance Market Size 2024 to 2033

The medical devices vigilance market involves monitoring, reporting, and managing adverse events and safety concerns related to medical devices. This includes evaluating device performance, potential risks, and any issues reported by healthcare professionals or patients. The market aims to ensure the safety and efficacy of medical devices, protecting public health and maintaining regulatory compliance.

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Growth Factors

The growth of the medical devices vigilance market is primarily driven by the increasing adoption of medical devices worldwide, the rise in chronic diseases, and the growing aging population. Additionally, advancements in medical technology and the integration of digital health solutions contribute to the market’s expansion. Regulatory requirements for stringent post-market surveillance and vigilance are also fueling the market’s growth.

Region Insights

North America dominates the medical devices vigilance market due to its robust healthcare infrastructure, advanced medical device industry, and strong regulatory frameworks. Europe follows closely, with strict regulatory requirements and established healthcare systems. The Asia-Pacific region is expected to experience significant growth due to rising healthcare investments, increasing adoption of medical devices, and a large patient population.

Medical Devices Vigilance Market Scope

Report Coverage Details
Growth Rate from 2024 to 2033 CAGR of 8.19%
Global Market Size in 2023 USD 80.40 Billion
Global Market Size in 2024 USD 86.99 Billion
Global Market Size by 2033 USD 176.80 Billion
Largest Market North America
Base Year 2023
Forecast Period 2024 to 2033
Segments Covered By Delivery Mode, By Application, and By End-user
Regions Covered North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa

Medical Devices Vigilance Market Dynamics


Key drivers of the medical devices vigilance market include the increasing complexity of medical devices, the need for continuous monitoring of device performance, and the desire to prevent adverse events. Technological advancements in data collection and analysis tools also enable more efficient vigilance activities, facilitating timely identification and resolution of potential issues.


Opportunities in the medical devices vigilance market include the integration of artificial intelligence and machine learning to enhance data analysis and prediction capabilities. Additionally, collaboration between regulatory agencies, manufacturers, and healthcare providers can lead to more efficient vigilance processes. Expansion into emerging markets presents further opportunities for growth.


Challenges in the medical devices vigilance market include the need for standardized reporting and data management practices across regions and the complexity of managing large volumes of data from various sources. Ensuring data privacy and security while maintaining transparency can also be challenging. Additionally, staying up-to-date with changing regulatory requirements and managing compliance can pose difficulties for market players.

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Medical Devices Vigilance Market Recent Developments

  • In June 2022, Italy instituted substantial changes in national regulations on medical device vigilance in accordance with the procedures by European Regulations. 2017/475 for medical devices and 2017/476 for in vitro diagnostics.

Medical Devices Vigilance Market Companies

  • AssurX Inc.
  • Sparta System
  • Oracle Corporation
  • Xybion Corporation
  • Sarjen Systems Pvt. Ltd.
  • MDI Consultants, Inc.
  • AB-Cube
  • Laerdal Medical.
  • Omnify Software, Inc.

Segments Covered in the Report

By Delivery Mode

  • On-demand
  • On-premise

By Application

  • Diagnostics
  • Therapeutics
  • Surgical
  • Research

By End-user

  • Clinical Research Organizations (CROs)
  • Business Process Outsourcing (BPO)
  • Original Equipment Manufacturers (OEM)
  • Other End-users

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

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