Why clinical investigations are key in ensuring the safety of software as medical devices 

Why clinical investigations are key in ensuring the safety of software as medical devices feature image

The rapid advancement of technology in medicine has paved the way for innovative software applications that are now integral to patient care. These software tools have the potential to revolutionise medical practices, enabling more accurate diagnoses, effective prevention strategies, efficient monitoring, and improved treatment of various medical conditions.

However, with these advancements, new challenges and risks arise, necessitating rigorous evaluations to ensure that these software tools meet the highest safety and performance standards.  

This article will explore the significance of clinical investigations in assessing the safety and effectiveness of software as medical devices (SaMD) and how they contribute to advancing patient care and medical innovation. 

The importance of clinical investigations for SaMD

Clinical investigations involve subjecting new software tools and applications to rigorous clinical trials and comprehensive studies of their safety and effectiveness. This process identifies potential risks or adverse events associated with the software, and its suitability for use in clinical settings can be determined.

The aim is not simply to fulfil regulatory requirements but to safeguard the well-being and safety of patients. By conducting clinical investigations, the safety and effectiveness of the software can be ensured, enabling confident strides in medical innovation. 

Advantages of clinical investigations for SaMD

Clinical investigations play a pivotal role in determining the effectiveness of software in achieving its intended purpose. For instance, AI-powered software designed for medical diagnostics must undergo rigorous testing to ensure its accuracy and reliability. This enables healthcare professionals to make informed decisions about incorporating the software into their practice, ultimately leading to improved patient outcomes. 

Clinical investigation site

Furthermore, clinical investigations enable medical device manufacturers and software developers to enhance their products by identifying areas that require adjustments. If a clinical investigation reveals that an AI-based tool is less effective than desired, developers can make necessary changes to improve its performance. This iterative process contributes to the development of better software and, consequently, improved patient care over time. 

Planning a clinical investigation for software as a medical device

Conducting a clinical investigation can be a complex and time-intensive endeavour. Therefore, it is crucial to collaborate closely with clinical research professionals and experts well-versed in relevant regulations to ensure compliance with necessary safety and performance requirements for medical software. 

clinical investigation meeting

The planning phase can be broken down into six steps, as seen below.

1. Defining the intended use of the software

Before initiating a clinical investigation, clearly defining the software’s intended purpose is essential. This determination facilitates the selection of appropriate study design and endpoints to evaluate the software’s safety and effectiveness. 

2. Identifying the patient population

The patient population must be clearly defined, specifying inclusion and exclusion criteria. This ensures that study results are applicable to the intended population and that the software’s risks and benefits are appropriately assessed. 

benefit-risk ratio

3. Developing a study protocol and essential documentation

The study protocol should outline the study design, endpoints, statistical analysis plan, and other relevant study details. To ensure ethical and regulatory compliance, the protocol should be reviewed and approved by an institutional review board (IRB) or ethics committee. 

4. Conducting the study

The study should be conducted at selected clinical sites according to the approved protocol and any applicable regulatory requirements. Data should be collected using a case report form (CRF) and managed and monitored in accordance with the data management plan (DMP) and monitoring plan (MP), respectively. 

5. Analysing the results

Study results should be meticulously analysed based on the statistical analysis plan (SAP) to assess the software’s safety and effectiveness. Any adverse events or safety concerns must be reported to the relevant regulatory bodies. The findings should be described in a comprehensive Clinical Study Report (CSR). 

6. Submitting regulatory filings

If the software intends to be marketed as a medical device, regulatory filings (technical documentation) may need to be submitted to governing bodies such as the FDA (Food and Drug Administration) in the US and NB (Notified Body) in European Union.  

Getting software as a medical device on the market

To market software as a medical device in Europe, it is essential to adhere to the key regulatory frameworks, namely the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). These regulations govern the classification and requirements for software classified as a medical device (SaMD).  

Consequently, SaMD must meet the same regulatory standards as traditional medical devices or in vitro diagnostic products. This entails fulfilling the general safety and performance requirements (GSPR) and undergoing a conformity assessment procedure before it can be made available on the market.  

Overview ISO 14155

By adhering to the requirements outlined in the MDR or IVDR, consulting the MDCG guidance documents, following the IEC 62304 standard, and complying with the ISO 14155 standard for clinical investigations, manufacturers can ensure that their SaMDs are safe, effective, and compliant with EU regulations. This approach enhances the likelihood of market success and contributes to improved patient outcomes. 


In conclusion, clinical investigations of software as medical devices (SaMD) are vital in ensuring medical software safety, effectiveness, and reliability. These investigations subject the software to rigorous clinical trials and comprehensive studies, identifying potential risks and evaluating its suitability for clinical use.

By adhering to robust protocols and collaborating with experts, the boundaries of medical technology can be pushed while safeguarding patient well-being.  

Would you like to know more about Clinical Investigation?

Take a look at our online Clinical Investigation for Medical Devices and ISO 14155 course that focuses on good clinical practice (GCP) for the design, conduct, recording, and reporting of clinical investigations carried out on human subjects to assess the clinical performance or effectiveness and safety of medical devices.

The course covers an orientation of the clinical investigation process according to the EN ISO 14155:2020 standard and the standard’s relation to MDCG guidance documents. This practical course is suitable for anyone working in clinical research and medical device development, such as regulatory affairs associates, QA engineers, and clinical research specialists.

medical device hq instructors - Maria Nyakern

Maria Nyåkern

Maria Nyåkern, Ph.D., is a consultant, entrepreneur, and B2B service provider in the medical device industry; she is the founder of AKRN Scientific Consulting, a CRO specializing in medical devices and minimally invasive cardiovascular therapies.

Maria is also a valued and respected trainer on clinical evaluation and clinical investigations of medical devices according to the EU MDR 2017/745 and the ISO 14155:2020 standard. She has vast ‘ hands-on’ experience, having set up and managed dozens of clinical investigations, and tens of thousands of patients, for different medical devices and indications for many of the top ten medical device manufacturers in the industry.

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