Before a medical device is marketed to the public, it needs to undergo a rigorous analysis to ensure that it is safe and effective.
Devices sold in the European Union need to meet the standards published by the International Medical Device Regulators Forum (IMDRF), a group of regulators from around the world.
Most recently, the IMDRF’s Medical Device Clinical Evaluation Working Group published the European Union (EU) Medical Device Regulations (MDR) 2017/745, which provides guidance for medical writers offering their expertise in the clinical evaluation process.
One critical document in the process of marketing medical devices is the Clinical Evaluation Report. What are Clinical Evaluation Reports? And what roles do medical writers play in creating them?
Clinical Evaluation Reports
In the AMWA webinar CER 101: Introduction to Clinical Evaluation Report for Medical Writers, expert Isabelle Searcy, PhD, explores the regulatory landscape and the role of medical writers in creating Clinical Evaluation Reports.
A Troubled History
Before the release of MDR, a number of problematic medical devices were marketed, resulting in negative outcomes and stories. In the webinar, Searcy points out that metal-on-metal hip implants, pelvic mesh, fallopian tube coil, and PIP breast implants were marketed without a full understanding of what would happen over the lifetime of the device. In some cases, there were limited clinical studies, truncated literature searches and methods of appraisal, and limited postmarket requirements.
That is why the IMDRF refined the process to help ensure the safety of devices.
Defining Clinical Evaluation
The IMDRF 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 determine the safety and performance of devices are sourced from studies (in-house or sponsored), scientific articles about similar devices and about the device under evaluation sourced from systematic literature reviews, and postmarket surveillance.
Clinical Evaluation Documents
The clinical evaluation process involves several documents, which have some elements in common.
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Clinical Evaluation Plan (CEP) defines the scope, the plan for data collection, appraisal, and analysis. It also defines the safety and performance objectives for the medical device.
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The Clinical Development Plan (CDP) is a plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility, and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a Post-Market Clinical Follow-up (PMCF) Plan with an indication of milestones and a description of potential acceptance criteria. This is included as part of the CEP.
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The Literature Review, a cornerstone for a compliant CER, is a systematic and methodical literature review. It is crucial to plan every stage of this process in order to identify all the relevant published literature for the device and the claims made about it. A literature review consists of two phases, the literature search and the evaluation of the available literature. This can be included as a separate document (a Literature Review Report or LITR).
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The Clinical Evaluation Report (CER) examines the results of the clinical evaluation and establishes the Acceptance Criteria for the Safety and Performance Objectives.
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Summary of Safety and Clinical Performance (SSCP)—for IIb Implantables and Class III devices.
Structure of a Clinical Evaluation Report
A Clinical Evaluation Report marks the point in the life cycle of a device where all the data are compiled in a comprehensive report. A CER includes the following sections.
- Executive summary
- Scope
- Device description
- Clinical background/state of the art
- Preclinical/nonclinical data
- Appraisal of clinical data (including the literature report)
- Analysis of clinical data
- Results of Post Market Surveillance (PMS), vigilance database searches, and PMCF activities
- A benefit-risk assessment
- Conclusion as to whether the device conforms to relevant MDR Annex I General Safety and Performance Requirements (GSPRs) and is suitable for its intended purpose
Medical Writing Skills
Medical writers can play a critical role in creating excellent CERs. For example, technical writing involves paying close attention to details and noticing inconsistencies between documents.
In a Medical Device Regulation (MDR) CER, the systematic literature review is a comprehensive analysis of existing literature relevant to the medical device being evaluated. It serves to provide a critical summary of the available evidence to support the safety and performance claims for the device. Medical writers play a crucial role in creating systematic literature reviews by conducting in-depth searches of relevant databases, analyzing and synthesizing the data, and summarizing the findings in a clear and concise manner. Their expertise ensures that the literature review is thorough, objective, and compliant with regulatory requirements, ultimately supporting the overall quality and integrity of the CER. A particular set of skills is needed to conduct literature searches for CERs. Every article returned in searches must be documented, even the ones that are excluded.
Medical writers can use their skills to compile reports from multiple studies and conduct literature searches. For example, State of the Art searches look at similar devices from competitors. Pertinent Data need to be summarized so reviewers can visualize the relevant data.
Other critical skills used in drafting CERs are the ability to analyze scientific articles to determine their relevance to the device, the ability to summarize data to understand the “big picture,” and the flexibility to deal with the inevitable challenges of working on a collaborative team.
Helping Safe and Effective Devices Reach the Market
The Clinical Evaluation Report is just one critical step in the process of bringing effective and safe medical devices to the public. Medical writers bring an important set of skills and knowledge that can ensure the safety and efficacy of these life-saving products.
CER 101: Introduction to Clinical Evaluation Report for Medical Writers provides an overview of the process of creating the CER and other critical documents in the life cycle of medical devices.
AMWA acknowledges the contributions and peer review from Madison Hedrick, MA in the development of this AMWA resource.
