Ethan Drower, Co-Founder and Operating Partner of CiteMed03.25.22
Medical devices must fulfill a need, solve a problem, and be safe.
If a device is designed to accomplish something new, it is important to establish if there is a market need the device will fulfill, and that it can do so safely and efficiently.
For established device types, you should demonstrate that your device is current with the state-of-the-art and that the benefit of using the device is worth the risk.
It is an evaluation and conclusion of the clinical data collected for your device with the specific purpose of demonstrating that your medical device is safe and efficient while delivering on clinical performance.
More specifically, a Clinical Evaluation Report documents the assessment and analysis of clinical data collected for a medical device to verify the clinical safety and efficacy of the device.
It is comprised of clinical investigation of the device itself and/or existing clinical studies for equivalent devices.
Clinical Evaluation Reports are essential to sell or distribute medical devices in Europe and form a critical part of the conformity assessment by the notified body.
The goal of the clinical evaluation report is to establish that any risks associated with the intended purpose of the device are acceptable when weighed against the clinical benefit it offers users.
The first step in writing a Clinical Evaluation Report is determining the scope of the clinical evaluation and developing a clinical evaluation plan (CEP).
The clinical evaluation plan describes the devices that are investigated in the clinical evaluation report.
The description should include the intended purpose and target population of the device, the device’s sizes and/or models, the indications of the device, and the clinical benefits to patients.
It also includes manufacturer details, equivalent devices, and any other information relevant to the clinical evaluation.
Most commonly this is done through a literature search of the scientific literature, but other available clinical data should also be included, such as internally available data (complaints, ongoing clinical study reports, meeting abstracts, etc.), clinical experience, or clinical trials, and post-market surveillance data.
Once you have identified clinical data, you must determine a literature review strategy.
Literature reviews are essential for the clinical evaluation report and mandatory under the MDR.
For many medical device companies, the literature review represents the majority, if not all, of the clinical data they collect on their devices. Without it, it would be impossible to demonstrate the safety and efficacy of their device during the clinical evaluation.
Once you have collected your clinical data, you must appraise it.
Appraising data means reviewing it for relevance, applicability, quality, and significance.
This is where you determine if the clinical data collected is useful for your device and its clinical indications.
Your data analysis should include:
This is where you analyze your clinical data and come to conclusions regarding the safety and efficacy of your device.
Considering the many different types of medical devices out there, it is difficult to write a definitive list of what should be included in the clinical evaluation report, but generally, you should include the following elements:
A critical part of the clinical evaluation report process is to establish procedures and systems to update the report as needed, whether this is annually or whenever there is new clinical information available (this depends on the device classification).
Any new clinical data that impacts the clinical evaluation must be recorded and subsequently reflected in an updated clinical evaluation report. If the clinical evaluation report is not updated accordingly, you jeopardize your conformity assessment.
Writing and maintaining the clinical evaluation report can seem like a tedious regulatory activity, but producing compliant clinical evaluation reports continuously is a strict requirement of the European MDR. Services like CiteMed will help speed up this entire process.
While the report is only a part of the technical file, you would do well to consider it a separate document due to its importance in the conformity assessment.
Failure to maintain a current clinical evaluation report at all times threatens your regulatory compliance to the EU medical device regulations and your ability to commercialize your medical device in Europe.
Ethan Drower is the co-founder and operating partner of CiteMed, which is revolutionizing the European Union Medical Device Regulation (EU MDR) process. Literature Search and Review is the cornerstone of medical device companies' Clinical Evaluation Report, and CiteMed has made this process more streamlined and optimized than ever. The CiteMed team was formed to deliver a high volume of beautifully written and formatted Literature Reviews on timelines that will enable companies to meet their EU MDR goals. CiteMed's top goal is to help companies get their medical products to market as quickly as possible, all while maintaining state-of-the-art compliance with the European Commission regulations.
If a device is designed to accomplish something new, it is important to establish if there is a market need the device will fulfill, and that it can do so safely and efficiently.
For established device types, you should demonstrate that your device is current with the state-of-the-art and that the benefit of using the device is worth the risk.
What is the Clinical Evaluation Report (CER)?
The Clinical Evaluation Report (CER) is a critical component of the Technical File for conformity assessment and subsequent CE Marking in Europe.It is an evaluation and conclusion of the clinical data collected for your device with the specific purpose of demonstrating that your medical device is safe and efficient while delivering on clinical performance.
More specifically, a Clinical Evaluation Report documents the assessment and analysis of clinical data collected for a medical device to verify the clinical safety and efficacy of the device.
It is comprised of clinical investigation of the device itself and/or existing clinical studies for equivalent devices.
Why Do I Need a Clinical Evaluation Report?
Clinical Evaluation Reports are required for all medical devices commercialized in Europe and are described thoroughly in the European Medical Device Regulation (MDR 2017/745).Clinical Evaluation Reports are essential to sell or distribute medical devices in Europe and form a critical part of the conformity assessment by the notified body.
The goal of the clinical evaluation report is to establish that any risks associated with the intended purpose of the device are acceptable when weighed against the clinical benefit it offers users.
How Do I Write my Clinical Evaluation Report?
Define the scope and draft a clinical evaluation plan (CEP)The first step in writing a Clinical Evaluation Report is determining the scope of the clinical evaluation and developing a clinical evaluation plan (CEP).
The clinical evaluation plan describes the devices that are investigated in the clinical evaluation report.
The description should include the intended purpose and target population of the device, the device’s sizes and/or models, the indications of the device, and the clinical benefits to patients.
It also includes manufacturer details, equivalent devices, and any other information relevant to the clinical evaluation.
Identify and Appraise Pertinent Data
Next, you have to identify the available clinical data for your device.Most commonly this is done through a literature search of the scientific literature, but other available clinical data should also be included, such as internally available data (complaints, ongoing clinical study reports, meeting abstracts, etc.), clinical experience, or clinical trials, and post-market surveillance data.
Once you have identified clinical data, you must determine a literature review strategy.
Literature reviews are essential for the clinical evaluation report and mandatory under the MDR.
For many medical device companies, the literature review represents the majority, if not all, of the clinical data they collect on their devices. Without it, it would be impossible to demonstrate the safety and efficacy of their device during the clinical evaluation.
Once you have collected your clinical data, you must appraise it.
Appraising data means reviewing it for relevance, applicability, quality, and significance.
This is where you determine if the clinical data collected is useful for your device and its clinical indications.
Analyze Your Collected Data
Analyzing your data is an essential step in reaching conclusions about compliance with the applicable General Safety and Performance Requirements (GSPRs). These requirements include performance and safety, reduction of risks, risk management systems, residual risks, and several others.Your data analysis should include:
- Benefit/risk profile based on current knowledge and state-of-the-art
- Residual risks
- Adequacy of the medical device manufacturers' information materials, as well as any inconsistencies with the existing clinical investigations and documentation
- Uncertainties or unanswered questions
Write Your Clinical Evaluation Report
Once all your clinical data has been collected and appraised, it is time to write your report!This is where you analyze your clinical data and come to conclusions regarding the safety and efficacy of your device.
Considering the many different types of medical devices out there, it is difficult to write a definitive list of what should be included in the clinical evaluation report, but generally, you should include the following elements:
- Device information, such as intended use, medical device design, manufacturer name, regulatory history, and any other relevant data.
- Technical device description, such as intended use and target population, classification, therapeutic or diagnostic claims, clinical background, etc.
- Any identified clinically equivalent device and a justification of its equivalence
- Existing clinical investigation and data
- Summary of clinical data and review, including documented systematic literature searches and reviews
- Data appraisal methodology and parameters
- Conclusions about safety, performance, and conformity, as well as benefit-risk determination
Clinical Evaluation Report Updates
The clinical evaluation report must be updated continually throughout the lifetime of your device as part of the post-market surveillance and vigilance requirements.A critical part of the clinical evaluation report process is to establish procedures and systems to update the report as needed, whether this is annually or whenever there is new clinical information available (this depends on the device classification).
Any new clinical data that impacts the clinical evaluation must be recorded and subsequently reflected in an updated clinical evaluation report. If the clinical evaluation report is not updated accordingly, you jeopardize your conformity assessment.
Writing and maintaining the clinical evaluation report can seem like a tedious regulatory activity, but producing compliant clinical evaluation reports continuously is a strict requirement of the European MDR. Services like CiteMed will help speed up this entire process.
While the report is only a part of the technical file, you would do well to consider it a separate document due to its importance in the conformity assessment.
Failure to maintain a current clinical evaluation report at all times threatens your regulatory compliance to the EU medical device regulations and your ability to commercialize your medical device in Europe.
Ethan Drower is the co-founder and operating partner of CiteMed, which is revolutionizing the European Union Medical Device Regulation (EU MDR) process. Literature Search and Review is the cornerstone of medical device companies' Clinical Evaluation Report, and CiteMed has made this process more streamlined and optimized than ever. The CiteMed team was formed to deliver a high volume of beautifully written and formatted Literature Reviews on timelines that will enable companies to meet their EU MDR goals. CiteMed's top goal is to help companies get their medical products to market as quickly as possible, all while maintaining state-of-the-art compliance with the European Commission regulations.
