Summary

The Europe Medical Device Vigilance Software market size was valued at US$ 143.9 million in 2023 and is expected to reach US$ 280.23 million by 2031; it is estimated to record a CAGR of 8.7% from 2023 to 2031.

The Europe medical device vigilance software market consists of countries such as Germany, France, the UK, Spain, Russia, and the Rest of Europe. Germany dominated the market in 2023, followed by France and UK respectively. In terms of revenue, Germany held significant the Medical Device Vigilance Software market share in 2023. Owing to the high rate of technology adoption, coupled with the presence of various multinational companies, Germany serves as a significant expansion base for the manufacturing sector in Europe. Germany's energy consumption is significant, making it the largest energy consumer in the region, surpassing France by 40%. The country's consumption levels are driven by its extensive industrial and economic activities and its massive population. In addition, a rise in investment toward energy transition by investing in heating and cooling systems such as Medical Device Vigilance Software are expected to boost the market in the coming years. However, the impacts of the COVID-19 outbreak are still impacting production in the manufacturing industry. The production dropped by 1.2% in 2023 as compared to 2022. Four key industries driving the economic growth of the country include automotive, mechanical engineering, chemical, and electrical industries. BASF SE, Siemens AG, Daimler AG, and other major players have established manufacturing facilities in the country. These companies are planning to expand their facilities to boost production as well as fulfill consumer demand across the country. Therefore, the expansion of these industries is anticipated to fuel the medical device vigilance software market growth in the coming years in Germany.

Based on End Use Vertical, the market is divided into CROs, BPO, OEMs, and others. The original equipment manufacturers segment held the largest medical device vigilance software market share in 2023. Medical device original equipment manufacturers (OEMs) are responsible for the entire lifecycle of the medical devices which includes its engineering, production, and often compliance with regulatory standards. In addition, after the medical device is sold, OEMs are responsible for the post-market surveillance of their medical devices to monitor their performance and safety in the market. OEMs are the primary end users of medical device vigilance software. It helps them ensure the safety of their products throughout the product lifecycle, including post-market surveillance, adverse event reporting, and compliance with regulations. The software helps in real-time tracking of their product performance. It also allows them to identify and respond quickly to any safety signals and ensure that issues are addressed promptly. The medical device vigilance software provided in Europe assists the OEMs with European medical device vigilance reporting, post-market surveillance, and creating procedures for such activities. They also help the OEMs stay compliant with Medical Device Regulation (MDR) No. 2017/745 (for medical devices or active implantable medical devices (MDs)) and In Vitro Diagnostic Device Regulation (IVDR) No. 2017/746 (for in vitro diagnostic (IVD) devices)..

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; and Xybion Digital Inc. are among the key Medical Device Vigilance Software market players that are profiled in this market study.

The overall Europe Medical Device Vigilance Software market size has been derived using both primary and secondary sources. Exhaustive secondary research has been conducted using internal and external sources to obtain qualitative and quantitative information related to the Europe Medical Device Vigilance Software size. The process also helps obtain an overview and forecast of the market with respect to all the market segments. Also, multiple primary interviews have been conducted with industry participants to validate the data and gain analytical insights. This process includes industry experts such as VPs, business development managers, market intelligence managers, and national sales managers, along with external consultants such as valuation experts, research analysts, and key opinion leaders, specializing in the Medical Device Vigilance Software market.

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Table of Contents

TABLE OF CONTENTS

1. Introduction
1.1 The Insight Partners Research Report Guidance
1.2 Market Segmentation
2. Executive Summary
2.1 Key Insights
2.2 Market Attractiveness
3. Research Methodology
3.1 Secondary Research
3.2 Primary Research
3.2.1 Hypothesis formulation:
3.2.2 Macro-economic factor analysis:
3.2.3 Developing base number:
3.2.4 Data Triangulation:
3.2.5 Country level data:
4. Europe Medical Device Vigilance Software Market Landscape
4.1 Overview
4.2 PEST Analysis
4.3 Ecosystem Analysis
4.3.1 List of Vendors in the Value Chain
5. Europe Medical Device Vigilance Software Market – Key Market Dynamics
5.1 Europe Medical Device Vigilance Software Market – Key Market Dynamics
5.2 Market Drivers
5.2.1 Stringent Regulatory Requirements Related to Medical Devices
5.2.2 Rise in Medical Technology
5.2.3 Increased Complexity of Medical Devices
5.3 Market Restraints
5.3.1 Data Privacy and Cybersecurity Threats
5.4 Market Opportunities
5.4.1 Digital Transformation in Healthcare
5.4.2 Growing Medical Devices Market
5.5 Future Trends
5.5.1 Software as a Medical Device
5.6 Impact of Drivers and Restraints:
6. Europe Medical Device Vigilance Software Market Analysis
6.1 Europe Medical Device Vigilance Software Market Revenue (US$ Million), 2021–2031
6.2 Europe Medical Device Vigilance Software Market Forecast and Analysis
7. Europe Medical Device Vigilance Software Market Analysis – by Application
7.1 Diagnostic
7.1.1 Overview
7.1.2 Diagnostic: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
7.2 Therapeutic
7.2.1 Overview
7.2.2 Therapeutic: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
7.3 Surgical
7.3.1 Overview
7.3.2 Surgical: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
7.4 Research
7.4.1 Overview
7.4.2 Research: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
7.5 Others
7.5.1 Overview
7.5.2 Others: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
8. Europe Medical Device Vigilance Software Market Analysis – by Deployment Mode
8.1 Cloud
8.1.1 Overview
8.1.2 Cloud: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
8.2 On-Premise
8.2.1 Overview
8.2.2 On-Premise: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
9. Europe Medical Device Vigilance Software Market Analysis – by End Use Vertical
9.1 Clinical Research Organizations (CROs)
9.1.1 Overview
9.1.2 Clinical Research Organizations (CROs): Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
9.2 Business Process Outsourcing (BPO)
9.2.1 Overview
9.2.2 Business Process Outsourcing (BPO): Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
9.3 Original Equipment Manufacturers (OEMs)
9.3.1 Overview
9.3.2 Original Equipment Manufacturers (OEMs): Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
9.4 Others
9.4.1 Overview
9.4.2 Others: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
10. Europe Medical Device Vigilance Software Market – Country Analysis
10.1 Europe
10.1.1 Europe Medical Device Vigilance Software Market Breakdown by Countries
10.1.2 Europe Medical Device Vigilance Software Market Revenue and Forecast and Analysis – by Country
10.1.2.1 Europe Medical Device Vigilance Software Market Revenue and Forecast and Analysis – by Country
10.1.2.2 Germany: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
10.1.2.2.1 Germany: Europe Medical Device Vigilance Software Market Breakdown by Application
10.1.2.2.2 Germany: Europe Medical Device Vigilance Software Market Breakdown by Deployment Mode
10.1.2.2.3 Germany: Europe Medical Device Vigilance Software Market Breakdown by End Use Vertical
10.1.2.3 France: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
10.1.2.3.1 France: Europe Medical Device Vigilance Software Market Breakdown by Application
10.1.2.3.2 France: Europe Medical Device Vigilance Software Market Breakdown by Deployment Mode
10.1.2.3.3 France: Europe Medical Device Vigilance Software Market Breakdown by End Use Vertical
10.1.2.4 United Kingdom: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
10.1.2.4.1 United Kingdom: Europe Medical Device Vigilance Software Market Breakdown by Application
10.1.2.4.2 United Kingdom: Europe Medical Device Vigilance Software Market Breakdown by Deployment Mode
10.1.2.4.3 United Kingdom: Europe Medical Device Vigilance Software Market Breakdown by End Use Vertical
10.1.2.5 Spain: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
10.1.2.5.1 Spain: Europe Medical Device Vigilance Software Market Breakdown by Application
10.1.2.5.2 Spain: Europe Medical Device Vigilance Software Market Breakdown by Deployment Mode
10.1.2.5.3 Spain: Europe Medical Device Vigilance Software Market Breakdown by End Use Vertical
10.1.2.6 Russia: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
10.1.2.6.1 Russia: Europe Medical Device Vigilance Software Market Breakdown by Application
10.1.2.6.2 Russia: Europe Medical Device Vigilance Software Market Breakdown by Deployment Mode
10.1.2.6.3 Russia: Europe Medical Device Vigilance Software Market Breakdown by End Use Vertical
10.1.2.7 Rest of Europe: Europe Medical Device Vigilance Software Market – Revenue and Forecast to 2031 (US$ Million)
10.1.2.7.1 Rest of Europe: Europe Medical Device Vigilance Software Market Breakdown by Application
10.1.2.7.2 Rest of Europe: Europe Medical Device Vigilance Software Market Breakdown by Deployment Mode
10.1.2.7.3 Rest of Europe: Europe Medical Device Vigilance Software Market Breakdown by End Use Vertical
11. Competitive Landscape
11.1 Heat Map Analysis by Key Players
11.2 Company Positioning & Concentration
12. Industry Landscape
12.1 Overview
12.2 Market Initiative
12.2 New Product Development
13. Company Profiles
13.1 Oracle Corp
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
13.2 AB Cube S.A.S.
13.2.1 Key Facts
13.2.2 Business Description
13.2.3 Products and Services
13.2.4 Financial Overview
13.2.5 SWOT Analysis
13.2.6 Key Developments
13.3 Sarjen Systems Pvt. Ltd
13.3.1 Key Facts
13.3.2 Business Description
13.3.3 Products and Services
13.3.4 Financial Overview
13.3.5 SWOT Analysis
13.3.6 Key Developments
13.4 AssurX, Inc.
13.4.1 Key Facts
13.4.2 Business Description
13.4.3 Products and Services
13.4.4 Financial Overview
13.4.5 SWOT Analysis
13.4.6 Key Developments
13.5 UL Solutions Inc
13.5.1 Key Facts
13.5.2 Business Description
13.5.3 Products and Services
13.5.4 Financial Overview
13.5.5 SWOT Analysis
13.5.6 Key Developments
13.6 Honeywell International Inc
13.6.1 Key Facts
13.6.2 Business Description
13.6.3 Products and Services
13.6.4 Financial Overview
13.6.5 SWOT Analysis
13.6.6 Key Developments
13.7 PTC Inc
13.7.1 Key Facts
13.7.2 Business Description
13.7.3 Products and Services
13.7.4 Financial Overview
13.7.5 SWOT Analysis
13.7.6 Key Developments
13.8 Intel Corp
13.8.1 Key Facts
13.8.2 Business Description
13.8.3 Products and Services
13.8.4 Financial Overview
13.8.5 SWOT Analysis
13.8.6 Key Developments
13.9 Max Application
13.9.1 Key Facts
13.9.2 Business Description
13.9.3 Products and Services
13.9.4 Financial Overview
13.9.5 SWOT Analysis
13.9.6 Key Developments
13.10 Xybion Digital Inc.
13.10.1 Key Facts
13.10.2 Business Description
13.10.3 Products and Services
13.10.4 Financial Overview
13.10.5 SWOT Analysis
13.10.6 Key Developments
14. Appendix
14.1 Appendix
14.2 About The Insight Partners