Clinical evaluation of medical devices and in vitro diagnostics: Why it is so important
The clinical evaluation of medical devices is an essential step to assess and ensure the safety and performance, including clinical benefits, of the medical product. But what exactly is a clinical evaluation? How does it work, and what requirements must manufacturers consider in the process?
What does the term ‘clinical evaluation’ mean?
Clinical evaluation is an ongoing, systematic process within the product lifecycle of medical devices. During this process, manufacturers create essential documents such as the clinical evaluation plan and the clinical evaluation report. The goal is to ensure the safety, performance, and clinical benefits of a product, which are crucial for its approval in the European market.
Clinical evaluation is integrated into various lifecycle phases, from development to market introduction and monitoring. It is a part of medical device development and technical documentation and must follow the General Safety and Performance Requirements (GSPR) for the product to be approved. Consequently, every medical device manufacturer goes through this process with their respective medical device.
The strict regulatory requirements of the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) govern this process in detail. So, what are the challenges during clinical evaluation, and what should manufacturers pay particular attention to?
What are the challenges of clinical evaluation?
The clinical evaluation of medical devices and in vitro diagnostics is a necessary step to ensure safety and effectiveness for patients and users. However, like many processes, there are also questions and challenges associated with it. Here are some of the aspects:
Addressing these challenges requires careful planning, various resources, and compliance to best practices during execution.
What is the process of conducting a clinical evaluation?
It follows a structured process that spans the entire product lifecycle of medical devices. This process includes:
Good to know: The Benefit-Risk Profile
A crucial factor in the clinical evaluation of medical devices is the benefit-risk profile. It involves demonstrating, with predetermined parameters, that the product is safe and that the benefits outweigh the potential risks. To substantiate clinical benefit, guidelines from medical professional societies, clinical trials, or studies are used.
Therefore, manufacturers of medical devices must develop methods and establish them within their companies to detect side effects and monitor the benefit-risk ratio. These results must be documented comprehensibly, and the benefit-risk profile should be assessed at regular intervals as part of post-market surveillance.
Requirements for Authors
The creation of a clinical evaluation demands a high level of expertise from the authors, including skills in areas such as scientific research, medical writing, as well as knowledge about the technology and application of the product. This expertise should be coupled with clinical experience.
When is a clinical evaluation required?
According to the MDR, it must be conducted in the following scenarios:
- New features and characteristics that have been implemented during the product’s development process
- Significant changes to the product
- A change in the intended purpose
- Implantable products or those in Risk Class III
However, there are some exceptions to the requirement for clinical investigation, which are precisely outlined in Articles 61(4 ff.) of the MDR:
- Modified medical devices by the same manufacturer
- A comparable product to a medical device from another manufacturer
- Certain legacy products
- Certain (low-risk) types of products, such as dental materials. The MDR establishes clear criteria for when a clinical investigation is necessary to ensure that new medical devices meet the required standards for safety and performance.
Conclusion
Clinical evaluation is an important process that medical device manufacturers should actively integrate. To meet the extensive and responsible requirements:
- careful planning with defined procedures,
- valid data and literature research,
- adherence to best practices and state of the art,
- collaboration among experts from different disciplines are essential.
When combined with other processes, synergy and positive effects can be achieved for patients, users, and manufacturers alike.
Focusing on the essentials in the clinical evaluation process – here‘s how it’s done
BAYOOSOFT is dedicated to assisting manufacturers of medical devices and in vitro diagnostics in digitizing their processes. Few industries are as heavily regulated as the medical technology sector. To allow you to focus on what truly matters, such as the clinical evaluation process, we provide specialized software solutions that support you throughout the entire product lifecycle.
Learn more about how to digitize your processes with our management solution by joining one of our upcoming webinars.
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