Before a medical device can be marketed, regulators require evidence that it is safe, performs as intended, and provides clinical benefit.
This evidence is gathered through the clinical evaluation process, which involves reviewing and analyzing available clinical data about the device. Medical writers often help document findings in a formal report submitted to regulators.
This blog post describes Clinical Evaluation Reports (CERs) and their structure, outlines steps for creating them, and discusses key skills medical writers use when developing these documents.
What Are Clinical Evaluation Reports (CERs)?
The Clinical Evaluation Report (CER) is a document that compiles and presents the findings of a medical device’s clinical evaluation, with the goal of showing that the device is both safe and performs effectively for its intended purpose. It provides the evidence used by Notified Bodies, independent organizations responsible for assessing medical devices, to determine whether the manufacturer qualifies for a CE mark, which permits the device to be marketed within the European Union (EU).
To understand how CERs are developed and evaluated, it is important to first examine the clinical evaluation process that underpins them.
Understanding Clinical Evaluation in Medical Devices
The International Medical Device Regulators Forum (IMDRF), a global group of regulatory authorities, defines clinical evaluation as “a set of ongoing activities that uses scientifically sound methods for the assessment and analysis of clinical data to verify the safety, clinical performance and/or effectiveness of the medical device when used as intended by the manufacturer.”
The clinical data used to evaluate the safety and performance of a device are derived from in-house or sponsored studies, scientific literature on the device and comparable devices identified through systematic literature reviews, and Post-Market Surveillance (PMS) activities.
In the European Union, manufacturers must comply with the Medical Device Regulation (EU) 2017/745 (also known as EU MDR), which establishes requirements for demonstrating device safety and performance. Guidance such as MEDDEV 2.7/1 Rev. 4 continues to inform best practices for conducting clinical evaluations and preparing CERs.
Why Comprehensive CERs Matter
A strong CER can provide several benefits, including a more efficient path to regulatory approval, faster time to market, and a positive impression on Notified Bodies. Ultimately, it can contribute to safer medical devices for patients.
In addition, a well-developed CER supports ongoing post-market activities, including Post-Market Clinical Follow-up (PMCF) plans. It can also help identify potential risks and guide risk mitigation strategies, such as the development of new safety features or design improvements.
The Stages of the CER
Since the release of EU MDR, the clinical evaluation process for medical devices has become more complex, presenting an opportunity for medical writers to help evaluate and report on data related to safety and performance requirements.
In an AMWA Journal article, Sidonie Jones, MA, MPhil, PhD, wrote about a session led by Kristen Petersen, BA, on creating readable CERs. Peterson explained 5 stages in the process of developing a CER in collaboration with stakeholders:
- Stage 0: Defining the Scope. This foundational stage identifies the devices under evaluation and their various versions and accessories.
- Stage 1: Identifying Relevant Data. Data are identified from different sources, including the scientific literature, manufacturer-held data (e.g., sponsored studies and PMS activities), and information available to the public.
- Stage 2: Appraising the Data. At this stage, the identified data are presented clearly and critically appraised to assess quality and relevance.
- Stage 3: Analyzing the Data. The appraised data are evaluated to determine the device’s safety and performance.
- Stage 4: Conclusion. The findings are synthesized in the CER to support submission, with updates required on a regular schedule or sooner if new information on device safety and performance becomes available.
These stages describe how a CER is developed, but the broader clinical evaluation process is supported by additional documents.
Documents Supporting the Clinical Evaluation Process
Medical writers may develop key materials that support steps in the clinical evaluation process, including these documents
- The Clinical Evaluation Plan (CEP) defines the scope, the plan for data collection, appraisal, and analysis, as well as the acceptance criteria for the device’s safety and performance objectives. The CEP includes the plan for the systematic literature review and may reference the Clinical Development Plan (CDP), which describes the planned progression of clinical studies from preliminary investigations to confirmatory research to demonstrate the device is safe and performs as intended.
- The Clinical Evaluation Report (CER) includes the systematic literature review report, examines the results of the clinical evaluation, and assesses the device against the acceptance criteria for safety and performance objectives defined by the CEP.
- The Summary of Safety and Clinical Performance (SSCP) provides a publicly available, plain-language summary of the device’s safety and clinical performance for Class IIb implantable and Class III devices (under EU MDR).
Structure of a CER
A CER marks the point in the life cycle of a device where all the data are compiled in a comprehensive report. It typically involves cross-functional teamwork and communication. Information comes from a variety of sources, such as systematic literature reviews and technical documentation from the device manufacturer.
A CER typically includes the following components:
Component |
Definition |
|
Executive summary |
Provides an overview of the CER, including key findings on safety, clinical performance, and benefit-risk conclusions |
|
Scope |
Defines the purpose, objectives, and boundaries of the clinical evaluation, including the device, its intended use, and relevant variants or configurations |
|
Device description |
Describes the device, including design, parts, materials, mechanism of action, intended purpose, and contraindications |
|
Clinical background/state of the art |
Summarizes current clinical practice and available technologies to contextualize the device and support evaluation of benefits and risks |
|
Preclinical/nonclinical data |
Presents nonclinical data from bench, laboratory, and in vivo studies used to support the evaluation of the device’s safety and performance |
|
Appraisal of clinical data |
Critically evaluates clinical data for quality and relevance, including data from literature and clinical investigations |
|
Analysis of clinical data |
Synthesizes appraised data to determine whether the device meets safety and performance requirements |
|
Results of PMS activities (including PMCF activities) and vigilance database searches |
Summarizes real-world data on device performance, including adverse events, complaints, and PMCF findings |
|
A benefit-risk assessment |
Evaluates whether the clinical benefits of the device outweigh its risks under intended use conditions |
|
Conclusion |
States whether the device meets MDR Annex I General Safety and Performance Requirements (GSPRs) and is suitable for its intended purpose |
Key Medical Writing Skills for CERs
Developing a CER is a complex and time-intensive process, often taking months and producing documents that may exceed 100 pages. Medical writers play a central role in ensuring these documents are clear, accurate, and compliant with regulatory expectations.
Conducting Systematic Literature Reviews
A major component of CER development is the systematic literature review. Medical writers must:
- Conduct systematic literature reviews using effective Boolean search strategies (e.g., in PubMed) and “state of the art” searches to identify similar devices from competitors.
- Ensure that systematic literature reviews are thorough, transparent, and compliant with regulatory requirements.
- Identify, interpret, and synthesize scientific evidence in an unbiased and reproducible manner.
- Document all search results, including excluded articles.
- Critically appraise studies for quality, limitations, and relevance.
- Apply knowledge of clinical trial design, research methods, and basic statistics.
- Use citation management tools to organize references and ensure traceability.
Technical Writing
At its core, CER development relies on strong technical writing skills. This includes:
- Identifying inconsistencies across documents and data sources.
- Ensuring accuracy and completeness in how information is presented.
Analyzing and Synthesizing Data
Beyond reviewing the literature, writers must synthesize all available evidence to support the clinical evaluation. This includes:
- Integrating data from multiple sources (e.g., literature, clinical studies).
- Summarizing data to understand the “big picture.”
Communication and Collaboration
Because CERs require input from multiple stakeholders, strong communication skills are essential. Medical writers must:
- Collaborate with cross-functional teams (e.g., regulatory, quality, engineering).
- Maintain flexibility to deal with the challenges of working on a collaborative team.
- Translate complex findings into clear language, including plain-language summaries (e.g., SSCPs).
- Work effectively with global stakeholders across time zones and language differences.
Understanding Regulatory Expectations
Finally, effective CER writing requires an understanding of how these documents are reviewed. Familiarity with evaluation frameworks, such as MDCG 2020-13, helps writers anticipate reviewer responses and ensure that key requirements are addressed.
Helping Safe and Effective Devices Reach the Market
The CER is just one critical step in bringing effective and safe medical devices to the public. Medical writers bring an important set of skills and knowledge that support this effort.
AMWA acknowledges the contributions of Brittany Jaekel, PhD, and Madison Hedrick, MA, for peer review in the development of this AMWA resource.
