The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has published a template of the clinical evaluation report, accompanied by guidance intended to provide device manufacturers and other parties involved with the additional information related to the matter. At the same time, it is also important to mention that the guidance does not contain any binding provisions and thus should not be treated as an official EC document.
Clinical Evaluation Report – Regulatory Background
The present MDCG guidance is dedicated to the regulatory aspects related to the clinical evaluation assessment reports (CEAR) – a special document to be issued by the notified body, containing the evaluation of the clinical evidence provided by the medical device manufacturer as a part of the clinical evaluation report (CER). The requirement prescribing the obligation to submit the document of this type is being prescribed by the Medical Device Regulation 2017/745 (MDR) that supersedes the Directives regulating the operations with medical devices.
According to the document, the clinical evaluation is closely related to the quality management system (QMS) to be implemented by the medical device manufacturer in order to ensure compliance with the applicable standards. The MDCG also states that the information related to the clinical evaluation should also comply with the technical documentation. In particular, the clinical evaluation has close connections with such spheres as:
- Risk management process,
- Post-market surveillance (including corrective and preventive actions),
- Post-market clinical follow-up plan and the appropriate report,
- Instructions for use and risk warnings.
Clinical Evidence Review
The MDCG states that the notified body, a special entity designated to perform conformity assessment within the scope of its designation, shall conduct a rigorous evaluation of the clinical evidence provided by the manufacturer, while all findings of such an assessment should be duly documented.
When assessing the clinical evidence provided by the medical device manufacturer, the notified body shall cover the following key points:
- Suitability of the data related to the equivalent device (similar medical device already placed on the market) indicated by the manufacturer. In particular, the notified body shall compare both the device subject to review and its equivalent to make reasonable conclusions regarding the admissibility and relevance of the data related to the equivalent device when assessing the features of the new one.
- All conclusions made by the medical device manufacturer in its own clinical evaluation should be additionally verified by the notified body. Verification is needed for the aspects related to the risk management, benefit-risk evaluation, the instructions for use to be supplied with the device, and also the post-market surveillance plan developed by the medical device manufacturer.
- Additional information generated in the course of post-market activity should be also subject to review to be performed by the notified body.
As a result, the notified body responsible for the medical device shall create a CEAR covering all the points listed here above. The present MDCG guidance provides a template of such a document and describes the way the activities related to the clinical evaluation should be documented by all the parties involved including medical device manufacturers and notified bodies.
MDCG Guidance Structure
In order to assist the parties the document is addressed to with its correct interpretation and application, the MDCG provided additional explanations and clarifications regarding the way the document should be used. In particular, the MDCG states that the document contains the list of kept points to be covered and also the information to be provided. At the same time, the MDCG emphasizes that everything included in the guidance could be subject to changes reflecting amendments to the applicable regulations. The advisory body also utilizes the concept of the minimum content – the lowest threshold of the information’s completeness and its applicability to the particular purpose. Thus, the final guidance document dedicated to the clinical evaluation reports is still to be issued by the MDCG.
It is also stated that the report should contain information on both any non-compliance identified during the assessment and the particular action taken by the medical device manufacturer to fix them. However, it is not required to include all information in the report – final results and conclusions would be sufficient.
CEAR Third Party Access
The MDCG also mentions that besides the notified bodies and medical device manufacturers, some other parties will also have access to the clinical evaluation assessment report and the information contained therein.
- Designated authorities, the national regulating authorities responsible for the designation of the notified bodies, will use CEARs to evaluate the actions performed by the notified body, including all procedures and the way they were documented.
- Expert panels of the European Commission will be also allowed to have access to the reports. In particular, they will have access to the information related to the clinical evidence provided by the manufacturer. It is also important to mention that the expert panels are entitled to request the notified body to provide its conclusion regarding the assessment.
When providing the clinical evaluation assessment report to any third parties, the notified body shall take all the steps necessary to protect personal data it may contain and prevent its disclosure.
Additional Rules and Requirements
The CEAR template contains a tick-box indicating that the final assessment is positive. The MDCG explicitly states that this tick-box should be marked only in case if all non-compliances identified in the course of evaluation have been successfully covered by the medical device manufacturer. In case if there are several minor non-compliances, that do not prevent the notified body from issuing a positive decision, such non-compliances should be described in details, and it is also necessary to indicate the particular actions to be taken by the medical device manufacturer to close them, and the estimated timeline for such actions.
The particular structure of the clinical evaluation report and the scope of information to be included therein depends on the:
- type of assessment, and
- medical device subject to evaluation.
The MDCG additionally emphasizes that all applicable sections should be completed, relevant conclusions reached and corresponding boxes ticked for the report to be complete.
According to the template published by the MDCG, the clinical evaluation assessment report shall contain the following mandatory parts and elements:
- General administrative information – this part of the report should contain information about the medical device subject to review, its manufacturer, and the notified body performing the assessment. This section should also contain details about the type of assessment, its intended purpose, and the scope of information included in the report.
- Information about experts carrying out the evaluation, including their names and details about their expertise.
- Description of the medical device in question, the indication of its class under the risk-based classification, specifications, and information materials provided by the medical device manufacturer. This section should also contain references to the equivalent devices.
- Review of the relevant clinical literature.
- Details regarding the clinical investigations.
- Details regarding post-market surveillance and post-market clinical follow-up.
- Details regarding the instructions for use and labeling.
- Summary and conclusions.
Summarizing the information provided here above, the MDCG guidance accompanying the clinical evaluation assessment report provides notified bodies with the necessary information regarding the content of the reports, and the way it should be provided.
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