Medical Device Clinical Trials

Clinical trials are an essential part of the development and regulatory approval process for medical devices.

They provide insights into the safety, effectiveness, and performance of these devices.

In this article, we will take a closer look at medical device clinical trials, their initiation process, different stages and types, and how they contribute to post-market surveillance. Additionally, we will explore how Matrix Requirements can assist you in optimizing your clinical trial strategy.

Clinical trials underpin medical device market entry, safeguarding public health through stringent evaluation.

In the medical device sector, clinical investigations are a pivotal step; they are designed to assess safety, performance, and clinical benefits, verifying that devices perform as intended before reaching end-users.

These trials are not monolithic; they vary by device class, intended use, and regulatory requirements.

What are clinical trials?

Clinical trials are fundamental for ensuring medical devices are both safe and effective.

Each year, thousands of clinical trials are launched to test the safety and efficacy of medical devices.

They provide vital data that supports regulatory submissions and approvals, guiding the development of innovations that improve patient outcomes.

Carefully executed clinical trials are a prerequisite for market entry, providing the evidence needed for regulatory compliance and user confidence.

When are clinical trials necessary?

The primary goal of clinical trials is to gather clinical data that provides valuable insights into the safety, effectiveness, and performance of medical devices.

Trials aim to assess the device's performance in real-world settings, evaluate its impact on patient outcomes, and identify any potential risks or adverse events.

By collecting robust clinical data through well-designed trials, researchers and regulatory authorities can make informed decisions regarding the approval, labeling, and appropriate use of medical devices.

Clinical trials are mandated when introducing a novel medical device with significant risk or unfamiliar technology, serving as critical gatekeepers in the patient safety continuum. So clinical trials depend on the classification of the medical device.

They become imperative for Class II and Class III medical devices, typically involving higher-risk profiles.

Furthermore, when substantial changes affect a device's use or safety, new clinical trial data may be requisite.

Modifications to design, material, or intended purpose necessitate reassessment via clinical studies, ensuring that the altered product maintains safety and efficacy.

Where predicate devices exist, clinical trials may evaluate the comparative performance, especially if claimed improvements impact clinical outcomes or user experience.

Substantiation through clinical trials is crucial when claims cannot be supported solely by analytical or laboratory tests, bridging the gap to real-world evidence.

How are medical device clinical trials initiated?

The inception of a medical device clinical trial hinges on meticulous planning and regulatory foresight. It begins with the development of a robust clinical trial protocol, encompassing objectives, design, methodology, statistical considerations, and compliance with appropriate regulations. This foundational document serves as the nexus for all subsequent trial-related activities and submissions.

Stakeholder engagement early in the process, including feedback from regulatory agencies and Institutional Review Boards (IRBs), is instrumental in refining the trial parameters and ensuring alignment with clinical and regulatory expectations. Only with this strategic groundwork can trials proceed efficiently towards their goal of substantiating safety and efficacy.

Regulatory Requirements for clinical data in the US

The US regulatory landscape presents complex pathways for medical device approval. Key among these is the Pre-Market Approval (PMA) process which demands rigorous scientific evaluation.

For Class III devices, those with high risk, the PMA pathway is required and includes substantial clinical data to assure safety and efficacy. This process often necessitates a series of clinical trials.

Conversely, the 510(k) clearance is sought for devices that can demonstrate equivalence to a legally marketed predecessor, known as a predicate. This may waive the need for extensive clinical trials in some instances.

There exists also a De Novo classification pathway for low to moderate risk devices lacking a clear predicate but still needing FDA approval without exhaustive clinical data.

Understanding these pathways is pivotal, as selecting the inappropriate route can result in significant delays or increased requirements for the clinical trial process.

Clinical Trial in the US

In the United States, medical device clinical trials are typically initiated by the device manufacturer or sponsor. To conduct a clinical trial in the US, the sponsor must follow specific steps and comply with regulatory requirements. Here are the key considerations for initiating a clinical trial in the US:

  1. Investigational Device Exemption (IDE): Before conducting a clinical trial, the sponsor must submit an Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA). The IDE application includes detailed information about the device, study objectives, trial design, patient population, and data collection plans. The FDA reviews the IDE application to ensure the trial's scientific validity and participant safety.

  2. Institutional Review Board (IRB) Approval: In the US, clinical trials involving human subjects must receive approval from an Institutional Review Board (IRB). The IRB is an independent committee responsible for reviewing and approving the trial protocol, ensuring the protection of participants' rights, welfare, and privacy. The IRB assesses the trial's ethical considerations, informed consent procedures, risk-benefit analysis, and data protection measures.

  3. Informed Consent: Informed consent is a critical component of clinical trials in the US. Before participating in a trial, potential participants (including US citizens) must be provided with detailed information about the trial, its purpose, procedures, potential risks and benefits, and their rights as participants. They must have the opportunity to ask questions and voluntarily provide their informed consent to participate.

  4. Patient Recruitment and Enrollment: When conducting clinical trials in the US, sponsors may specifically target US citizens as a trial patient group. This can be due to various factors, such as the device's intended use, patient demographics, or regulatory requirements. Patient recruitment and enrollment strategies should comply with applicable regulations and ethical considerations, ensuring fair and equitable access to participation opportunities.By following the proper regulatory steps, obtaining IDE approval from the FDA, receiving IRB approval, and ensuring informed consent from participants, sponsors can initiate medical device clinical trials in the US while upholding ethical standards and protecting participant rights.

It is important to note that the specific requirements and processes for clinical trials in the US may vary depending on factors such as the device's risk classification, intended use, and the trial's scope. Sponsors should consult the FDA's guidance documents and engage with relevant regulatory authorities to ensure compliance with US regulations.

By conducting clinical trials in the US and including US citizens as a trial patient group, sponsors can gather valuable data on the device's safety and effectiveness within the US population, contributing to the overall understanding of the device's performance and benefits.

Clinical Trial in the EU

In the European Union (EU), medical device clinical trials are governed by the Medical Device Regulation (MDR). To initiate a clinical trial in the EU, the sponsor must follow a specific process. Here are the key steps involved:

  1. Ethics Committee Approval: The sponsor must submit the clinical trial protocol to an ethics committee for review and approval. Ethics committees play a crucial role in ensuring the protection of participants' rights, safety, and well-being. They assess the trial's ethical aspects, including informed consent procedures, risk-benefit analysis, and data protection measures.

  2. Competent Authority Notification: After obtaining ethics committee approval, the sponsor must notify the competent authority in the respective EU member state where the trial will take place. The competent authority evaluates the trial's scientific validity, safety measures, and compliance with regulatory requirements.

  3. Clinical Investigation Application: Depending on the risk classification of the medical device, the sponsor may need to submit a clinical investigation application to the competent authority. This application includes detailed information about the device, trial design, patient population, and data collection methods.

  4. Approval and Monitoring: Once the competent authority reviews the clinical investigation application, they may grant approval to conduct the trial. Throughout the trial, the competent authority monitors its progress, ensuring compliance with regulatory requirements and participant safety.It is important to note that each EU member state may have its own specific requirements and processes for clinical trial initiation. Sponsors should consult the relevant national authorities and ethics committees to ensure compliance with local regulations.

In the EU, organizations conducting clinical trials often have their own internal ethical boards or committees responsible for reviewing and approving trial protocols. These boards ensure that the trials adhere to ethical principles and guidelines. Some notable ethical boards in the EU include:

  • Ethics Committees: These committees are independent bodies composed of healthcare professionals, scientists, legal experts, and patient representatives. They review and provide ethical oversight for clinical trial protocols, ensuring the protection of participants' rights, safety, and well-being.

  • Institutional Review Boards (IRBs): IRBs are commonly found in academic and research institutions. They review and approve clinical trial protocols, focusing on ethical considerations, participant recruitment, and informed consent processes.

  • Data Protection Authorities: In addition to ethics committees and IRBs, data protection authorities play a crucial role in ensuring the privacy and confidentiality of participants' personal data during clinical trials. They ensure compliance with data protection regulations, such as the General Data Protection Regulation (GDPR) in the EU.

When initiating a clinical trial in the EU, it is essential to engage with these ethical boards and authorities to ensure compliance with ethical standards and regulatory requirements.

By following the proper initiation process and obtaining approval from the relevant ethics committees and competent authorities, sponsors can conduct medical device clinical trials in the EU while upholding the highest ethical standards and ensuring participant safety.

Under the MDR, the standards for clinical evaluations have intensified. This shift necessitates developers to provide more substantial clinical evidence throughout the product lifecycle than with MDD. The MDR establishes enhanced post-market surveillance expectations, ensuring ongoing assessment of medical devices in a real-world context.

What are the Different Stages and Types of Medical Device Clinical Trials?

Pilot Studies

Pilot studies are small-scale trials conducted to assess the feasibility and safety of a medical device. These studies involve a limited number of participants and are often used to refine the trial protocol before proceeding to larger-scale trials. Pilot studies provide valuable insights into the device's performance, potential risks, and necessary adjustments for subsequent trials.

Pivotal Studies

Pivotal studies are large-scale trials designed to evaluate the safety and effectiveness of a medical device. These studies involve a significant number of participants and are crucial for obtaining regulatory approval. Pivotal studies generate robust clinical evidence to support the device's intended use and demonstrate its benefits outweigh any potential risks.

Post-Market Surveillance and Clinical Trials

Clinical trials do not end with regulatory approval. Post-market surveillance involves ongoing monitoring of the device's performance and safety in real-world settings. This surveillance may include additional clinical trials to gather long-term data, assess device performance in specific patient populations, or investigate any reported adverse events. Post-market clinical trials help ensure the continued safety and effectiveness of medical devices throughout their lifecycle.

Observational Clinical Activities

Observational clinical activities, such as registries and post-market studies, are done to gather real-world data on medical device performance. These activities involve monitoring device usage, patient outcomes, and any potential adverse events in a non-interventional manner. Observational studies provide insights into the device's long-term safety and effectiveness, complementing the data obtained from controlled clinical trials.

How Matrix Requirements Can Assist You

Matrix Requirements is a powerful tool that can assist medical device developers and regulatory affairs experts in optimizing their clinical trial strategy. 

Using MatrixRequirements, the risk management information can be used to derive necessary questions and clinical data needed to substantiate the validation of the product's risks, as well as derive requirements for clinical data monitoring in post-market surveillance. The item-based structure of information in the platform makes it easy to mark and select appropriate risks and product functions that need to be evaluated with real-life scenarios and clinical data, as well as respond to output from clinical testing with changed to the product's design or user documentation, and trace both risks to clinical data and clinical evaluation outcome to product changes.

Note: This article is for informational purposes only and should not be considered as medical or legal advice. Always consult with relevant authorities and professionals for specific guidance on medical device clinical trials.

About the Author
Regina Preysing
Partnerships Manager