The outcomes of a clinical examination of your medical device are documented in a Clinical Evaluation Report (CER). A CER is made up of clinical data that has been thoroughly examined and was obtained from either a clinical investigation of your device or the findings of studies on devices that are significantly similar to it. The CER shows that your product accomplishes its objectives without putting consumers or patients at further risk.
All medical devices marketed in Europe must have clinical evaluation reports. Your CER must be attached to your European CE Technical File and submitted to your Notified Body. To receive CE Marking for your device, which is necessary to sell or distribute medical devices in Europe, this Technical File is a critical step.
What is Clinical Evaluation?
Clinical evidence is continuously obtained over the course of a medical device’s lifecycle. As required by legislation, it is first carried out during the development of a medical device to identify the data that must be created in order to gain access to the market. The need for ongoing clinical evaluation arises from the fact that thorough data analysis ensures the device’s effectiveness and safety for the duration of its tenure on the market.
A methodically sound continuing process for gathering, evaluating, and analysing clinical data related to a medical device is clinical evaluation. Its main goal is to determine whether there is enough clinical proof to demonstrate adherence to the general safety and performance criteria (GSPRs) when using the device as per the manufacturer’s instructions for use.
When is a Clinical Evaluation Undertaken?
A medical device undergoes continuous clinical evaluation throughout its lifecycle. It is first done during the creation of a medical device for CE mark, and it is then updated frequently in accordance with required standards to get market access.
Premarket research and development processes serve as the basis for clinical evaluations that are conducted for the creation of new medical devices. To find any gaps in the available data, decide whether equivalence should be claimed, and specify the conditions for proving the device’s performance and safety, manufacturers undertake gap searches. Therefore, the clinical evaluation process should typically start before any clinical investigation because the initial clinical evaluation outlines the issues that will be answered by a clinical investigation.
What is Clinical Evaluation Report (CER)?
A technical document called a clinical evaluation report (CER) is required for medical device manufacturers who want to sell or distribute their products in Europe. The CER provides a comprehensive description of the medical device’s design and construction, intended use and applications, analysis and results from clinical studies, pertinent literature reviews, protocols, and usage instructions. Any medical device approved for the sale in Europe must be supported by a thorough CER report. A review of clinical safety and performance should be included in the report.
Importance of Clinical Evaluation
Both the Medical Devices Directive 93/42/EEC (MDD) and the Medical Devices Regulation (EU) 2017/745 (MDR) require medical device makers to develop a clinical evaluation for their products.
The primary objective of a clinical evaluation is to evaluate and examine clinical information about the medical device in order to provide evidence of its clinical performance and safety.
The clinical evaluation report is the outcome of the clinical evaluation. A device’s life cycle is followed through a continual process called clinical evaluation. This procedure is crucial for the CE Marking of medical devices under MEDDEV 2.7/1, rev. 4, and the MDR. It is strongly related to other crucial aspects, such as Risk Management and Post-Market Surveillance (PMS). It proves that your product accomplishes its objectives without putting users or patients at further risk.
Required updates to your Clinical Evaluation Report
Throughout the life of a medical device’s life cycle, a CER must be routinely updated. The document must include the clinical proof required to demonstrate compliance with the Essential Requirements (ERs) listed in MEDDEV 2.7/1 Rev. 4 Annex 1. (Safety and Performance Requirements in the MDR). Any significant modifications that affect the initial data must be noted and the CER must be updated accordingly. Along with the usage instructions, the document should also go into detail about the device’s construction, technical specifications, and physical characteristics.
How Long Does It Take To Write A CER?
It may take several weeks or months to collect, compile, and organize all the data that goes into the CER in accordance with the standards. Even after a product has received CE Mark certification, post-market surveillance[1] (PMS) is still a significant element of the process, and the manufacturer’s QMS must include PMS as a major component. In some circumstances, post-market clinical follow-up (PMCF), which entails proactive clinical data collection and evaluation to satisfy safety and performance standards, is also necessary.
The CER is a dynamic document. To maintain market access in the EU, prevent any product recalls, and streamline their time and resources spent on maintaining compliance, it is advised that medical device manufacturers create a strong procedure and strategy that incorporates best practices to maintain the document.
Requirements of a Clinical Evaluation Report (CER) for Medical Device Manufacturers
It is the manufacturer’s responsibility provide the agencies or other notified bodies with a clinical data summary on device performance. The architecture of a CER report is the same, even though the details vary depending on the type of device manufactured.
1. Summary
The summary is an overview of the CER report for external audiences at agencies/notified bodies. This section should summarize the:
- Benefit/Risk Profile
- Intended Target Groups
- Medical Indications
The summary should briefly explain how your manufacturing company came to the conclusion that the device has an acceptable benefit or the risk profile based on the “state of the art” medical evidence & research in addition to summarizing those findings.
2. Scope
This part ought to be very explicit on how the device operates and the technology involved. For extremely innovative devices or other devices that utilize advanced technologies, the scope section of a report may be quite lengthy.
3. Clinical Background
An extensive review of the clinical context around the medical device is intended for the clinical background part of a CER report. To provide reviewers with an idea of the current status of the field for the medical device under evaluation, authors should provide an outline of a literature review.
4. Device under Evaluation
The purpose of the section on the device under evaluation is to not only describe the device but also to explain the procedures used for the CER and the data analysis. A clinical evaluation’s basis, an equivalency demonstration (if appropriate), and the clinical data sets used should all be included. If the clinical evaluation is not supported by scientific literature, this part must explain why and provide equivalence explanation.
5. Conclusions
The explicit justification that the device complies with important necessities for patient safety forms the foundation of the CER decision. It should discuss the benefit/risk profile created during the analysis of clinical data and draw on the most recent research to demonstrate whether the device and any associated risks are superior to medical alternatives.
6. Dates & References:
The final section of the report operates similar to an appendix in an academic paper. It should include the following:
- Next clinical evaluation
- Date.
- Current clinical evaluation date.
- A signed statement from the evaluator.
- Final release data from the manufacturer.
- Evaluator Qualifications.
- References
How to Prepare a Clinical Evaluation Report (CER) For the Medical Devices?
A clinical evaluation takes place in 3 steps. In 1st step, manufacturers identify clinical data from existing literature, clinical experience, clinical trials/any combination of the three.1 Stage 2 involves appraising the data’s relevance, applicability, quality & significance. The 3rd step requires you to articulate your conclusions in the Clinical Evaluation Report, based on the data you collected.
Approach the Clinical Evaluation Report as a standalone document even though you will cover it with your technical file. A list of possible elements to include in your Clinical Evaluation Report is as follows:
- General information: device & manufacturer name.
- Concise physical & technical device description and intended application.
- Outline of intended therapeutic or diagnostic claims.3
- Clinical evaluation and data types.
- Summary of clinical data & review.
- Describe analyses used to assess performance, safety & relevance or accuracy of product literature.
- Conclusions about safety, performance & conformity
Various Stages in CER
Clinical Evaluation Reports, or CERs, are given a significant role in the MDR. The Technical File, which is the primary documentation that shows regulatory compliance and gives all the details about the device, includes the CER as one of its components. Companies that manufacture medical devices must take a number of steps to ensure that its CER is organized and maintained. Four stages make up the typical Clinical Evaluation Report documentation:
- Outlining the device’s capabilities, intended applications, and therapeutic/diagnostic claims.
- Recognizing and confirming clinical data.
- Analyzing and interpreting the data to determine whether it satisfies all the standards.
- Identifying dangers and ambiguities that might be clarified by post-market monitoring (PMS).
Writing a Highly Effective CER Report
However a Clinical Evaluation Report’s complexity can vary significantly, the result should always be the same. An agency or body that has been alerted should be able to read & understand the final report. To demonstrate device safety for sale in the European markets, it must provide enough information for readers to fully understand the data, analysis, and any conclusions made.
The duration and difficulty of writing a Clinical Evaluation Report report can differ greatly based on a number of variables, including the technology being examined. It may be substantially less difficult if you can avoid clinical data analysis by establishing equivalence. The CER must cover the aforementioned parts in every situation and present a compelling case for patient safety based on device quality.
Conclusion
A Clinical Evaluation Report (CER) is a comprehensive analysis of clinical data of pre-market and post market relevant to a medical device. It is a dynamic document that will be revised during the course of the medical device’s lifecycle. The CER must be updated to reflect any new information about your device that is discovered through post-market surveillance or a new literature search. Your clinical evaluation report must be updated per internal policy even if no new information is received.
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