Stringent Regulatory Requirements Related to Medical Devices to Fuel Europe Medical Device Vigilance Software Market Growth During Forecast Period 

According to our latest study, "Europe Medical Device Vigilance Software Market Size and Forecast (2021–2031), Regional and Country Share, Trend, and Growth Opportunity Analysis – by Application, Deployment Mode, and End-Use Vertical," the market 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 report includes growth prospects owing to the current Europe medical device vigilance software market trends and their foreseeable impact during the forecast period.    

Regulatory compliance plays a crucial role in the medical device market as it aims to ensure that a medical device meets all relevant regulatory requirements before it is marketed and used in clinical practice. Medical device regulatory compliance enables patient access to high-quality, safe, and effective medical devices and avoids access to unsafe products. If any medical device is not manufactured according to the regulatory measures or standards, it might not give precise findings or work well to treat the ailment. This may lead to a false diagnosis or an inability to treat the underlying illness, which would be harmful to the patient even more. Thus, the manufacturing and maintaining the proper functioning of the medical device is essential, which drives the need for a medical device vigilance system. Medical device vigilance software helps the device manufacturer monitor and report adverse events related to the medical devices. It helps the medical device manufacturer comply with specific regulations and safety standards.

A few of the regulatory compliance requirements related to the market are given below:

• The European medical device vigilance system, established by directives 93/42/EEC, 90/385/EEC, and 98/79/EC, aims to reduce risks to patient and user safety. The directives require medical device manufacturers to report certain events to the competent authority (CA). In Ireland, medical devices are regulated by the Health Products Regulatory Authority (HPRA). HPRA safety notices are considered a critical tool for communicating crucial medical device issues. HPRA safety notices provide important information about the safe use of medical devices, whether at home, in a hospital, or a community setting. Manufacturers and users must submit vigilance reports, including incidents and corrective actions, to the appropriate authorities (such as the HPRA in Ireland).
• Manufacturers must report vigilance issues in accordance with the European Guidelines for a Medical Devices Vigilance System (MEDDEV 2.12/11). Manufacturers must follow a systematic procedure to review device experience, identify risks, and report issues to authorities for appropriate action.
• The requirements by regulatory authorities across Europe have fostered the adoption of medical vigilance software for reporting processes, mitigating risks, and adhering to these regulatory standards.  

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 players profiled in the Europe medical device vigilance software market report. Several other major players were also studied and analyzed during the market study to get a holistic view of the market and its ecosystem.

The report includes the Europe medical device vigilance software market forecast by application, deployment mode, and end-use vertical. Based on application, the Europe medical device vigilance software market is segmented into diagnostic, therapeutic, surgical, research, and others. The diagnostic segment held the largest Europe medical device vigilance software market share in 2023.

The scope of the Europe medical device vigilance software market report focuses on the UK, Germany, France, Spain, Russia, and the Rest of Europe. Germany held the largest Europe medical device vigilance software market share in 2023, followed by France and the UK. According to the Act on Medical Devices (MPG) and the German Safety Plan for Medical Devices (MPSV), the Federal Institute for Drugs and Medical Devices (BfArM) ensures the central collection, analysis, and evaluation of risks arising from the use or application of medical devices—in particular, adverse effects, interactions with other substances or products, contra-indications, falsifications, operational defects, malfunctions, and technical defects—and co-ordinates the necessary measures to be taken. BfArM contributes to the safety of medical devices by performing risk assessments of such devices (medical device vigilance) and approving clinical studies on medical devices. These regulatory tasks are complemented and supported by research activities. This factor generates the need for carrying out efficient data collection and fault analysis solutions for the vigilance of medical devices, driving the medical device vigilance software market growth in Germany.  

France has been experiencing rapid advancements in the healthcare industry post-pandemic, with an investment plan worth ~US$ 21 billion (EUR 19 billion) for healthcare modernization. Today, initiatives such as a new digital health roadmap for 2023–2027 strengthen France's position as a leading market for digital health. This initiative creates opportunities for MedTech solutions, where the French reimbursement system for medical devices aims at accelerating the adoption of innovative digital health solutions. According to the International Trade Administration (ITA), in August 2024, there were more than 1,300 medical device companies in France. Out of France's 1,300 businesses, 92% are SMEs, with 88% producing only medical devices. Thus, the growing digitalization in the healthcare sector presents a huge opportunity for the medical device vigilance software adoption by medical device manufacturers.  

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