Clinical Evaluation Report Template and CAPTIS^®

Clinical evaluation for medical devices is a systematic process that is used to assess the safety and performance of a medical device by analysing clinical and non-clinical data. This evaluation helps demonstrate compliance with the existing regulatory requirements. It also helps in demonstrating that the device is safe to use and performs when used as per the manufacturer’s instructions. The process of evaluation of a device clinically is continuous and continues till the device lifetime. To keep the data up to date periodic revision is done along with the revision of associated documents like Post marketing survey documents (PMSR, PMSP etc).

For documenting this process of clinical evaluation, a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) for the medical device is created. While a CEP summarizes the process of clinical evaluation necessary for obtaining CE (conformité européenne) mark for the device, and provides in detail the pathway taken, a CER analyses data from multitude of sources like post marketing data, literature, adverse event databases, clinical trials etc. This process makes sure that the device meets regulatory requirements and is safe and effective for its intended use.

For documenting this process of clinical evaluation, a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) for the medical device is created. While a CEP summarizes the process of clinical evaluation necessary for obtaining CE (conformité européenne) mark for the device, and provides in detail the pathway taken, a CER analyses data from multitude of sources like post marketing data, literature, adverse event databases, clinical trials etc. This process makes sure that the device meets regulatory requirements and is safe and effective for its intended use.

The document is created in a template compliant to EUMDR. Medical Device coordination Group (MDCG 2020-13) provides a Clinical Evaluation Assessment Report (CEAR) template which is useful while creating the document. Major sections for the CER include:

• Executive Summary
• Background/Introduction
• Device Description
• Data Held by Manufacturer and External Data
• Data Analysis Including Risk-Benefit Analysis
• Conclusions

The sections within a CER are deeply interconnected, each contributing to the overall assessment of a medical device’s compliance with EU MDR. From the device description and clinical data to benefit-risk analysis and post-market surveillance, the information in each section flows seamlessly, supporting the next. This interconnectedness ensures a cohesive narrative, where each section reinforces the others, ultimately leading to a well-supported conclusion that demonstrates the device’s safety, performance, and regulatory compliance.

Celegence CAPTIS^® is designed to navigate this complexity of the CER sections. It is designed to cater to the needs of medical device manufacturers of all sizes, helping them achieve compliance with EU MDR and IVDR regulations more efficiently. It is a compliance software tool designed to streamline the creation of various regulatory documents for medical devices, including Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Summary of Safety and Clinical Performance (SSCPs), and Periodic Safety Update Reports (PSURs).

Using CAPTIS^® in CER offers multiple advantages. CAPTIS^® helps to manage the vast amount of source documents required to add the data in the sections, literature search and database integration like Adverse Event (AE) database integration and an automated template where the common data like device name is automatically filled in the CER leading to substantial time saving. The template in CAPTIS^® can also be modified and is downloadable at any point during creation of the document.

As with the interface being straightforward and easy to navigate and the use of templates and automated literature reviews, it is ensured that information is presented consistently across all documents. The automated literature module integrates seamlessly with databases like PubMed and Google Scholar which helps in easy retrieval and screening of relevant literature in turn reducing manual effort. The platform also integrates with AE databases like MAUDE, TPLC which are a major part of risk analysis for the CER.

Additionally, CAPTIS^® also helps in the editorial side of the document, ensuring use of predefined templates, automatic creation of abbreviation tables, keyword dictionary etc. Last but not least, CAPTIS^® also provides features for commenting, version control, and centralized documentation, facilitating collaboration among team members and ensuring that all contributions are traceable and auditable.

These features substantially decrease manual effort and chances of error, thereby increasing the efficiency and accuracy of CERs. This makes it easier for manufacturers to create complex regulatory documents for their medical devices.