Europe Medical Device Vigilance Software Market Report 2031 by Segments, Geography, Dynamics, Recent Developments, and Strategic Insights

The Europe medical device vigilance software market size is expected to reach US$ 280.23 million by 2031 from US$ 143.9 million in 2023. The market is estimated to record a CAGR of 8.7% during 2023–2031. Software as a medical device is likely to bring a new set of key trends in the market in the coming years.

Europe Medical Device Vigilance Software Market Analysis

Increasing regulatory compliance, rising medical technology, and increasing complexity of medical devices are driving the Europe medical device vigilance software market. The main goal of a medical device vigilance system is to improve the protection of the health and safety of patients, healthcare professionals, and the public by minimizing the probability of the recurrence of adverse incidents involving medical devices. This is achieved through a variety of mechanisms. Medical device vigilance entails gathering, assessing, understanding, and responding to new information about the risks associated with the use of medical devices. These risks are particularly adverse incidents, interactions with other substances or devices, contraindications, counterfeiting, malfunctions, and technical defects.

Europe Medical Device Vigilance Software Market Overview

The primary purpose of medical device vigilance software is to support post-market surveillance of medical devices, ensuring their continued safety and effectiveness throughout their lifecycle. Post-market surveillance is critical to ensure that there are no adverse events or other problems with a product. The risks with any unanticipated effects of long-term use are identified and addressed as soon as possible. The goal of post-market surveillance is to ensure that products remain safe and effective while also continuously monitoring their benefits and risks.

The features of medical device vigilance software include incident reports regarding malfunctions, gathering all pertinent data in accordance with medical device reporting, assigning special manufacturer report numbers, and fulfilling all paperwork and recordkeeping requirements; storing incident data, analyzing device attribution, and evaluating and investigating reports to quickly and easily retrieve the data; and creating numerous reports for submitting to various regulatory bodies across the region.

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Europe Medical Device Vigilance Software Market: Strategic Insights

Europe Medical Device Vigilance Software Market

• 
  CAGR (2023 - 2031)

  8.7%
• Market Size 2023
  US$ 143.9 Million
• Market Size 2031
  US$ 280.23 Million

Market Dynamics

GROWTH DRIVERS

• Stringent Regulatory Requirements Related to Medical Devices
• Rise in Medical Technology
• Increased Complexity of Medical Devices

FUTURE TRENDS

• Software as a Medical Device

OPPORTUNITIES

• Digital Transformation in Healthcare
• Growing Medical Devices Market

Key Players

• Oracle Corp
• AB Cube S A S
• Sarjen Systems Pvt Ltd
• AssurX Inc
• UL Solutions Inc
• Honeywell International Inc
• PTC Inc
• Intel Corp
• Max Application
• Xybion Digital Inc

Regional Overview

• Europe

Market Segmentation

Application

• Diagnostic
• Therapeutic
• Surgical
• Research

Deployment Mode

• Cloud
• On-Premise

End Use Vertical

• Clinical Research Organizations
• Business Process Outsourcing
• Original Equipment Manufacturers

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Europe Medical Device Vigilance Software Market Drivers and Opportunities

Increased Complexity of Medical Devices

Medical device software is a critical component of modern healthcare systems. Software solutions in the medical device market are required to manage user interfaces, patient data, regulations, and product complexity. Their adoption reduces the risks while developing medical devices and their software and helps accelerate software development and deployment. It oversees risk management in healthcare as well. As the medical device market expands, the challenge of balancing hardware, software, and regulation increases. Requirement management tools and medical device vigilance software are closely related in the healthcare industry with respect to medical device development and its lifecycle management. Thus, to handle the complexity of medical devices, the demand for medical device vigilance software is growing.

Advances in medical technologies have led to better diagnoses and treatments for earlier and more accurate diagnoses, more effective treatments, and ensuring the safety of the patients. Medical devices evolve rapidly with the integration of the digital system, modern and compact medical device designs, and reliance on the software system. This generates complexity in terms of monitoring, reporting, and ensuring the safety of the medical devices. In addition, adhering to stricter regulatory compliances encourages medical device manufacturers to adopt advanced software solutions that can handle the challenges due to the increased complexity of medical devices.

Digital Transformation in Healthcare

Europe's digital healthcare sector promotes the use of various digital technologies that improve healthcare facilities. The use of digital technologies for information and communication to manage illness, avoid health risks, and promote patient safety drives digitalization in the Europe healthcare sector. Authorities in Europe are constantly focused on providing enhanced services to the citizens. For this, they are continually engaged in investment activities. For example, the EU4Health Programme was adopted with a budget of over ~US$ 5.9 billion (EUR 5.3 billion) during the 2021–2027 period to build stronger, more resilient, and more accessible health systems. This investment fosters the healthcare system's digitalization and access to medicinal products, medical devices, and crisis-relevant products. With the majority of the new projects already underway since December 2023, the goal of the grants is to help EU countries implement the future European Health Data Space (EHDS). Such investment can promote the innovation, development, and adoption of medical device vigilance software that meets regulatory standards and improves patient safety. The adoption of vigilance software can enhance the resilience of health systems during health crises such as COVID-19. It can provide quicker reports and analyze data on medical device performance. During emergencies, it can support quicker decision-making and risk management. Thus, the digitalization of the healthcare system in Europe drives significant advancements across all aspects of healthcare, creating the potential for the industry to deliver better health outcomes more efficiently. This factor enables the adoption of solutions to minimize the risks to quality and fuels time to market and regulatory compliance, further fostering the demand for medical device vigilance software in Europe.

Europe Medical Device Vigilance Software Market Report Segmentation Analysis

Key segments that contributed to the derivation of the Europe medical device vigilance software market analysis are application, deployment mode, and end-use vertical.

• Based on application, the market is divided into diagnostics, therapeutic, surgical, research, and others. The diagnostic segment held the largest Europe medical device vigilance software market share in 2023.
• Based on deployment mode, the market is divided into cloud and on-premises. The cloud segment held a larger Europe medical device vigilance software market share in 2023.
• Based on end-use vertical, the market is divided into CROs, BPO, OEMs, and others. The original equipment manufacturers (OEMs) segment held the largest Europe medical device vigilance software market share in 2023.

Europe Medical Device Vigilance Software Market Share Analysis by Geography

The Europe medical device vigilance software market is segmented into Germany, France, the UK, Russia, Spain, and the Rest of Europe. Germany dominated the market in 2023, followed by France and the UK.

Adverse incidents involving medical devices in the UK must be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA oversees the UK medical device market. Once a medical device is placed on the UK market, the manufacturer is obligated to submit vigilance reports to the MHRA whenever certain types of incidents involving their device occur in the UK. The manufacturer must also take appropriate safety measures when necessary. The manufacturer must ensure that their device meets applicable safety and performance standards for the duration of its use. The medical device manufacturer, the UK Responsible Person, or the authorized representative based in Northern Ireland must report to the MHRA about incidents regarding the medical devices and post-market vigilance reports. Such mandates for the vigilance system report and surveillance drive the demand for medical device vigilance software for effective reporting and post-market surveillance.

Europe Medical Device Vigilance Software Market Report Scope

Europe Medical Device Vigilance Software Market News and Recent Developments

The Europe medical device vigilance software market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A few of the developments in the Europe medical device vigilance software market are listed below:

• Oracle announced new capabilities in its AI-supported Oracle Argus and Safety One Intake solutions to help life science organizations meet evolving regulatory requirements and the rising volume of adverse event case workloads. With new enhancements designed to increase productivity, improve data privacy, and enhance reporting, users can more efficiently address dynamic, country-specific regulations and requirements and speed the reliability and transparency of safety case management from clinical trials through post-marketing surveillance. (Source: Oracle Corporation, Press Release, July 2024)
• Ab Cube Company unveiled four new next-AI-generation vigilance applications in the AB Cube Galaxy. These new modules offer powerful enhancements to the core SafetyEasy Suite for fast, efficient, and scalable multivigilance operations. The company's new AI-driven module applies advanced Natural Language Processing (NLP) technology, allowing the customers to copy and paste the verbatim of their ICSR, which is then automatically converted into a case in the SafetyEasy Suite – reducing case intake effort by 70%. (Source: Ab Cube Company, Press Release, June 2024)

Europe Medical Device Vigilance Software Market Report Coverage and Deliverables

The "Europe Medical Device Vigilance Software Market Size and Forecast (2021–2031)" provides a detailed analysis of the market covering the areas mentioned below:

• Europe medical device vigilance software market size and forecast at regional, and country levels for all the key market segments covered under the scope
• Europe medical device vigilance software market trends, as well as market dynamics such as drivers, restraints, and key opportunities
• Detailed PEST and SWOT analysis
• Europe medical device vigilance software market analysis covering key market trends, regional framework, major players, regulations, and recent market developments
• Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the Europe medical device vigilance software market
• Detailed company profiles