Medical Device Vigilance Market Size, Share, By Device, Delivery Mode, Application, End-User, and Region - Trends, Analysis, and Forecast till 2035

Medical Device Vigilance Market Size, Share, By Device, Delivery Mode, Application, End-User, and Region - Trends, Analysis, and Forecast till 2035

Medical device vigilance is the continuous observation and reporting of unfavorable incidents related to the use of medical devices in order to spot possible issues and guarantee the devices' efficacy and safety. Further, the strict Medical Device Reporting (MDR) rules set forth by the FDA and EMA specify how adverse events and occurrences involving medical devices must be reported. The target market is projected to grow significantly owing to the increasing awareness of device safety among healthcare professionals and patients.

Medical Device Vigilance Market Report Highlights:

• The medical device vigilance market size is anticipated to grow at a rate of USD 164.6 billion by 2035.
• The market was projected to be valued at USD 64.6 billion in 2024.
• The target market is growing at a CAGR of 10.8%.
• North America held the largest share of the market in 2024.
• By product, rigid core LVT is expected to account for the largest share of the medical device vigilance market.
• The cloud based delivery mode segment is expected to lead the market during the forecast period.
• On the basis of application, the post-market surveillance segment dominates the market.
• Based on end-user, the market is led by the clinical research organizations (CROs) segment.

Key Benefits of Purchasing This Report

Gain valuable insights into revenue projections for the overall market and its sub-segments, benefiting industry leaders and new entrants.

Enhance your understanding of the competitive landscape to refine business positioning and optimize go-to-market strategies.

Stay informed on the latest trends in the Medical Device Vigilance Market, including key drivers, challenges, opportunities, and barriers.

Medical Device Vigilance Market Key Highlights:

In August 2024, Fisher & Paykel Healthcare Corp announced the launch of the F&P my820 System in the U.S. It is designed specifically to perform in home environments where temperatures can fluctuate, the F&P my820 System automatically adapts to environmental temperature changes using a built-in sensor. This sensor works to mitigate circuit condensate while also reducing device-wire clutter and providing patients with a simplified set-up process.

In May 2024, the Drugs Controller General of India (DCGI) has called for timely reporting of adverse events related to medical devices and directed all medical device license holders and manufacturers to report any adverse events related to life-saving medical equipment on the government’s Materiovigilance Programme of India (MvPI) platform stating that the move is vital to mitigate risks and safeguard public health.

Medical Device Vigilance Market Report Analysis:

Key Vigilance Considerations for Your Drug-Device Combination Product:

For instance, according to the research article published by Ernst & Young Global Ltd., in March 2022, the article highlights that the MDR's device vigilance requirements do not apply to integral drug-device combinations (DDCs) that are regulated as medicinal products. However, it is advised that the manufacturer of an integral DDC have the technical know-how and procedures integrated into their Quality Management System (QMS) for managing, assessing, and looking into any device-related complaints, if needed.

Important DDC manufacturers should also evaluate their pharmacovigilance agreements with suppliers to make sure they account for other information that would need to be gathered and shared, like device faults and occurrences related to devices.

Segmentation:

By Type:

• Diagnostic Devices
• Therapeutic Devices
• Monitoring Devices
• Surgical Devices
• Others

By Delivery Mode:

• On Premise
• Cloud Based

By Application:

• Post-Market Surveillance
• Adverse Event Reporting
• Risk Management
• Other Applications

By End User:

• Clinical Research Organizations (CROs)
• Business Process Outsourcing (BPO)
• Original Equipment Manufacturers (OEM)
• Others

By Region:

• North America
• U.S.
• Canada
• Europe
• Germany
• U.K.
• France
• Russia
• Italy
• Spain
• Netherlands
• Rest of Europe
• Asia Pacific
• China
• India
• Japan
• Australia
• Indonesia
• Malaysia
• South Korea
• Rest of Asia Pacific
• Latin America
• Brazil
• Mexico
• Argentina
• Rest of Latin America
• Middle East & Africa
• GCC
• Israel
• South Africa
• Rest of Middle East & Africa

Medical Device Vigilance Market Competitive Landscape

• Medtronic
• Johnson & Johnson MedTech
• Abbott Laboratories
• Siemens Healthineers
• Medline Industries
• Koninklijke Philips N.V.
• GE Healthcare
• Baxter International Inc.
• Boston Scientific Corporation
• Stryker Corporation
• Thermo Fisher Scientific Inc.
• Cardinal Health, Inc.
• Zimmer Biomet Holdings, Inc.
• Hologic, Inc.
• Fresenius Medical Care AG

Key Questions Answered in This Report

1. What was the size of the Medical Device Vigilance Market in 2024?

2. What is the expected growth rate of the Medical Device Vigilance Market during 2025-2035?

3. What are the key factors driving the Medical Device Vigilance Market?

4. What is the breakup of the Medical Device Vigilance Market based on the distribution channel?

5. What are the key regions in the Medical Device Vigilance Market?

6. Who are the key players/companies in the Medical Device Vigilance Market?

7. What are the drivers, restraints, and opportunities in the Medical Device Vigilance Market?