What Are Clinical Evaluation Reports?
When it comes to manufacturing and selling medical devices, there are several steps that a company must take to ensure their medical device is as safe and effective as advertised. Before releasing a medical device on the market, it must be carefully studied and tested, and clinical data must be generated to support the product claims.
After a device has been manufactured, but before being released on the market, it must undergo clinical evaluation. After it has undergone the evaluation, a Clinical Evaluation Report (CER) must be compiled and submitted to regulatory agencies. Typically, the Clinical Evaluation Report is necessary for an MDR (Medical Device Regulation).
What Is a Clinical Evaluation?
Before the CER can be completed, clinical evaluations must take place. The EU MDR refers to clinical evaluations as follows: “A systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a device to verify the safety and performance, including clinical benefits of the device when used as intended by the manufacturer.”
Per EU MDR regulations, manufacturers of medical devices must explain and evaluate the clinical evidence relating to the device to show conformity with MDR requirements. . Additionally, manufacturers must also ensure that their device complies with general safety and performance (GSPR) as per MDRs.
Clinical evaluation is not only required before releasing a product on the market but also must be ongoing while the medical device remains on the market. The follow-up process is known as Post Market Clinical Follow Up (PMCF). Manufacturers must continuously collect clinical data regarding the use of the device in the market. This ongoing process should be done to validate the performance and safety of the device, while identifying potential present or emerging risks indicated by the clinical data collected.
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What Is a Clinical Evaluation Report?
Once clinical evaluations have been completed, they must be compiled into a CER and submitted to the relevant Notified Body. A CER is a requirement within the European Union to demonstrate compliance with MDR and obtain a CE mark (European Conformity).
The following points for a CER should be considered for inclusion:
- Device Description, as well as its use and any relevant regulatory history or device classification
- Clinical background summary for the device and its intended purposes, indications and contraindications
- Documented systematic searches of clinical literature, as well as clinical practice guidelines, to show a thorough evaluation and review
- Demonstrated equivalence to other devices utilizing biological, technical, and clinical characteristics
- Summarized testing data of a nonclinical nature
- Summarized device sales, relevant complaints, as well as clinical data collected by the manufacturer and other surveillance data from post-market sales
- Documented and systematic searches of published clinical study reports, as well as any other clinical data, to create a thorough review of the device’s clinical performance, which requires medical review by qualified persons
- Summarized device usability data
- Completed appraisal of the available data to ensure applicability, relevance, significance, and quality
- Explained parameters and methods used in the assessment of safety, clinical benefits, and risk-benefit ratios
- Summarization of risk-benefit findings
Patient and consumer safety is the ultimate goal of any clinical evaluation report. For this reason, your CER should be comprehensive and well organized so that it can demonstrate the safety and efficacy of your device for the patient or consumer. By completing CER reports, a medical device can be safely released onto the market while also following up on any relevant post-market data obtained through clinical usage of the device.
The clinical evaluation report is a critical part of the approval process to comply with EU MDR requirements. It must be compiled from relevant pre-market clinical evaluations–as well as any post-market clinical evaluations–after the device is released. It is also required, as part of obtaining CE certification within the European Union, to ensure the device meets all relevant safety regulations.
Due to the cumbersome and difficult nature of examining and summarizing clinical reports relating to medical devices, an excellent option for evaluating clinical studies is software such as DistillerSR. DistillerSR simplifies and expedites the literature review process so that you can focus on the results rather than the research.