Clinical trials are considered the gold standard to provide clinical evidence that attests the safety and efficacy of a new medical device. The success of these studies depends on the implementation of a well-designed clinical evaluation plan, which can also include other types of clinical evidence. In this article, we share some of our expertise in conducting clinical trials and show how we design and implement a plan that leads towards a medical device approval.
This article is divided into four main parts: first, you will learn what clinical evidence is and why it is needed. Then, we define plans and explain how to design one. The next section is dedicated to the implementation of the plan and everything that happens after the research has started. Finally, we take a closer look at compliance with regulatory requirements, as this is a complex but very important point to be considered by manufacturers of medical devices. Explore all sections to master this interesting subject!
Why Clinical Evidence is Needed ?
Clinical evidence is a clinical evaluation report composed of a set of documents that contain all relevant clinical data proving that a medical device is effective (it serves its purpose) and safe (does not offer any risk to patients). It is an essential part of a medical device development process, as manufacturers need to demonstrate conformity to regulations before making the product available. As you will learn in a further section, regulatory requirements are designed to ensure that all healthcare that is being provided is safe and effective.
Therefore, clinical evidence is needed to obtain market authorization and, ultimately, to make new products available to patients, contributing to public health. There is more than one way to obtain clinical data and generate clinical evidence. Clinical trials, observational studies and case studies are all types of clinical evidence.

Clinical Trials
Clinical trials are the currently preferred method of clinical evaluation, as they provide robust evidence on a medical device’s safety and efficacy. Also known as interventional study, clinical trials are a type of clinical study in which volunteer participants are divided into groups to receive an intervention (a treatment) or no intervention, allowing researchers to evaluate the effects that it has on patients. In the case of medical devices, the trials assess the results of the use of the device by participants.
Clinical trials typically have three or four phases, with an increasing number of participants. They start with a small group of healthy individuals and progress with controlled testing on patients who were diagnosed with the condition that the treatment is designed for. To ensure the quality of the clinical evidence generated, clinical trials must be carefully designed and executed by experienced medical researchers.
Other Types of Clinical Evidence
Real-world evidence is another kind of clinical evidence. It can be generated through observational studies and case reports. Observational studies, as opposed to clinical studies, collect information about the use of a medical device without the intervention or control of researchers. Researchers simply “observe” a group of patients that is using the device, without manipulating the way the groups are formed.
Observational studies can be very useful to generate data about the long-term use of a device. Case reports, then, are a type of observational studies which are limited by a timeframe or specific group or population. Both types of studies can provide supporting evidence of a device’s safety and efficacy.
What is a Clinical Evaluation Plan ?
This is a comprehensive set of documents that will guide the research team collecting the evidence that is necessary to prove the safety and effectiveness of a medical device. Planning the clinical evaluation involves determining the ways through which clinical evidence will be generated, how the studies will be conducted, with which set of participants, and preparing for the last stages of the study such as post-market surveillance and performance evaluation. We will cover all these aspects in the next sections of this article.
The path towards regulatory compliance and approval starts with a well-designed clinical evaluation plan. Contract research organizations (CROs) work to help manufacturers achieve compliance and dedicate a lot of effort to building robust plans before starting a clinical trial. The evidence generated by the studies incorporated in the plan will contain all necessary data to prove that a product is ready to enter the market.
Clinical Evaluation Plan Structure
Now that you already know why clinical evidence is needed and how it should be planned to generate high-quality data, you are ready to learn how we build our plans. The following table outlines the main sections of a robust, well-designed plan :
NAME OF SECTION |
CONTENT |
Title |
Device name and brief description |
Team |
Names of people who will be conducting the clinical trial and description of their roles |
Device |
Describes the product in detail, including its intended use and safety parameters |
Scope |
Outlines the several stages of the clinical trial. This section should contain the study objectives and definition of the patient population, as well as a risk management plan |
Evaluation |
Describes the type of clinical study that will be conducted |
Literature Search |
Lists sources for supporting literature and how it will be documented |
References |
Lists any articles or other sources cited in the document. |
The study objectives should be specific, and clearly aligned with the device’s intended use. When determining the patient population, the device’s intended use should also be considered first and any exclusion and exclusion criteria or special groups will be identified. The description of the clinical study includes the study type (randomized controlled trial, non-randomized trial, etc.) and other specifications such as statistical analysis methods that will be used.
Risk Management Plan
After determining the safety parameters which will guide the risk assessment of the study, a risk management plan will be developed. This is a very important section of the complete plan which not only identifies potential risks of using the device, but also describes the strategies that can be used to mitigate those risks at any of the study’s stages.
To build a risk management plan, an evaluation of the device’s safety parameters, components, materials and recommended use is made. Then, during the risk assessment, adverse events reporting and risk analysis will be used to identify the probability of potential risks and develop strategies to avoid or alleviate them.
Risks at any level should be identified and documented, from discomfort to life-threatening situations. They could also be classified as biological risks (such as infections), mechanical and electrical risks.
Implementing a Clinical Evaluation Plan
After the study has been designed and clinical evaluation has been carefully planned, the research team is ready to start the clinical investigation. The first step will be to recruit patients and obtain their formal consent to participate. Then, data collection starts, and the study is constantly monitored to ensure patient’s safety and quality of data.
The patient population should reflect the device’s targeted group (defined by age, health condition and other factors). Patient demographics, medical history and outcomes reporting will also be included in the data to be analyzed.
Monitoring the study means conducting regular visits to the study site to ensure it is being conducted according to the protocol which was initially designed, and to ensure ongoing adherence to regulatory guidelines. During this phase, additional adverse events that are reported by patients will also be recorded and promptly addressed.
Evidence Generation and Post-Market Surveillance
These are the last stages of a clinical evaluation. During the evidence generation phase, researchers document clinical evidence on the device’s performance that demonstrates its ability to serve its intended purpose effectively. They also document all evidence of the device’s safety and compliance with regulations, after reviewing the pre-determined safety parameters.
Data from literature review and other clinical studies with similar devices is also collected and composes the clinical evidence set. The performance of the device being tested can be compared to one that is already on the market to generate evidence of its safety. Finally, post-market surveillance can also be conducted to achieve a comprehensive performance evaluation.
Post-market surveillance involves collecting and analyzing data after the device is already on the market to generate more evidence of its safety and identify any potential risks associated with its use that have not been addressed yet. Surveys can be circulated among patients who are using the device to obtain their feedback, which can give helpful information on the device’s overall performance.
As more data is generated, the device’s safety parameters and effectiveness are reassessed and, if necessary, additional clinical trials can be planned and the risk management plan can be updated. Together, the data collected and analyzed during the trials, literature reviews and post-market surveillance compose the performance evaluation of a new device. Performance evaluation can be supported by trials carried out in a laboratory setting or a clinical environment and by the results of patient-reported outcomes collecting.
Carefully planning evidence generation and performance evaluation methods is an essential step of good clinical evaluation. To generate high-quality and reliable data that demonstrates the safety and effectiveness of a new medical device, their performance, usability and safety should be assessed through clinical trials and may be supported by real-word evidence.

Evidence Generation and Post-Market Surveillance
These are the last stages of a clinical evaluation. During the evidence generation phase, researchers document clinical evidence on the device’s performance that demonstrates its ability to serve its intended purpose effectively. They also document all evidence of the device’s safety and compliance with regulations, after reviewing the pre-determined safety parameters.
Data from literature review and other clinical studies with similar devices is also collected and composes the clinical evidence set. The performance of the device being tested can be compared to one that is already on the market to generate evidence of its safety. Finally, post-market surveillance can also be conducted to achieve a comprehensive performance evaluation.
Post-market surveillance involves collecting and analyzing data after the device is already on the market to generate more evidence of its safety and identify any potential risks associated with its use that have not been addressed yet. Surveys can be circulated among patients who are using the device to obtain their feedback, which can give helpful information on the device’s overall performance.
As more data is generated, the device’s safety parameters and effectiveness are reassessed and, if necessary, additional clinical trials can be planned and the risk management plan can be updated. Together, the data collected and analyzed during the trials, literature reviews and post-market surveillance compose the performance evaluation of a new device. Performance evaluation can be supported by trials carried out in a laboratory setting or a clinical environment and by the results of patient-reported outcomes collecting.
Carefully planning evidence generation and performance evaluation methods is an essential step of good clinical evaluation. To generate high-quality and reliable data that demonstrates the safety and effectiveness of a new medical device, their performance, usability and safety should be assessed through clinical trials and may be supported by real-word evidence.
Understanding Medical Device Regulations
These regulations are designed to standardize safety parameters and ensure ongoing patient safety. They can, however, vary depending on the country or region and they are also being constantly updated by the regulatory bodies. In the US, for example, the Food and Drug Administration (FDA) is the agency which oversees the approval of new medical devices, allowing them to be marketed if they are considered safe and effective. In the EU, the Medical Devices Regulations (MDR) documents outline requirements for a product’s approval.
When conducting a clinical trial, it is advised that you partner with a CRO that has proven expertise in the market you are targeting. A well-designed clinical evaluation plan will also include strategies for conformity assessment, which is how manufacturers will demonstrate the device’s compliance with regulatory requirements.
Non-compliance can result in delays in the approval process and even fines and legal consequences for the manufacturer. This is why it is important to be updated on the current regulations which are relevant to that specific medical device, and to work closely with regulatory authorities to ensure ongoing compliance. Some regulatory bodies and groups provide comprehensive guidance documents and training programs which can be very helpful.
The evidence generated during the clinical evaluation will be part of the evidence package which will support a device’s approval process before it can be marketed, offering objective proof of its compliance with relevant regulations. Ultimately, the main goal of all planning stages we discussed here is to ensure that the device is safe for patients and that it is an effective treatment or support adequate to their condition.
Summarize
- Clinical evidence is a report composed of a set of documents that contain all relevant clinical data proving that a medical device is effective and safe. There are many ways of generating clinical evidence.
- A Clinical Evaluation Plan guides the evidence generation, defining the study objectives, patient population, study design, and risk management strategies, among other elements.
- After the plan is designed, it is implemented: the patient recruitment process is followed by data collection and the study is constantly monitored.
- Compliance with medical device regulations is essential to streamline the approval process and ensure it is safe for patients and serves its intended purpose.