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.
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.
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.
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.
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.
Key segments that contributed to the derivation of the Europe medical device vigilance software market analysis are application, deployment mode, and end-use vertical.
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.
| Report Attribute | Details |
|---|---|
| Market size in 2023 | US$ 143.9 Million |
| Market Size by 2031 | US$ 280.23 Million |
| Global CAGR (2023 - 2031) | 8.7% |
| Historical Data | 2021-2022 |
| Forecast period | 2024-2031 |
| Segments Covered |
By Application
|
| Regions and Countries Covered | Europe
|
| Market leaders and key company profiles |
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:
The "Europe Medical Device Vigilance Software Market Size and Forecast (2021–2031)" provides a detailed analysis of the market covering the areas mentioned below:
The List of Companies - Europe Medical Device Vigilance Software Market
The Europe medical device vigilance software market was estimated to be US$ 143.90 million in 2023 and is expected to grow at a CAGR of 8.7% during the forecast period 2024 - 2031.
Stringent regulatory requirements related to medical devices, rise in medical technology, and increased complexity of medical devices are the major factors that propel the Europe medical device vigilance software market.
Software as a Medical Device is anticipated to play a significant role in the Europe medical device vigilance software market in the coming years.
The key players holding majority shares in the Europe medical device vigilance software market are AB Cube S.A.S.; AssurX, Inc.; Oracle Corporation; Sparta Systems (Honeywell International Inc.); and Sarjen Systems Pvt. Ltd.
The Europe medical device vigilance software market is expected to reach US$ 280.23 million by 2031.
The incremental growth expected to be recorded for the Europe medical device vigilance software market during the forecast period is US$ 136.33 million.