The Clinical Evaluation Report (CER) is a prerequisite document required to be submitted to regulatory bodies along with the technical file as a part of CE marking, and conformity assessment process before the medical device manufacturer introduces the product in the European market.
The clinical evaluation report (CER) provides complete details of a medical device product in its entire lifecycle and is a mandatory document needed for the European Union market for all types of medical devices, components, and compounds. CER document is prepared based on the clinical evaluation of the medical device and is an important requirement to obtain CE marking. It is an important part of the technical file or the design dossier of the medical device manufacturer, and they need to be updated with regular reviews throughout the lifecycle of the device. The CER is an important live document that needs to be prepared based on solid foundations, evidence, and literature reviews of similar products, components, and compounds.
Manufacturers need to comply with European CER requirements that necessitate that the respective device or component achieve their intended purpose without exposing the patients, consumers or users to any adverse risk. Clinical data is recognized as the necessary evidence to validate the safety and performance of the medical devices, which is derived by conducting preclinical and clinical assessments, scientific literature and the clinical experience of comparable equipment. Evaluation and analysis of the clinical data are essential to validate the clinical safety and performance of the medical device, which is outlined in the Clinical Evaluation Report.
Clinical evaluation is an ongoing and continuous process that is integrated into the quality system and carried out throughout the life-cycle of the device. The initial report is prepared at the beginning of the CER’s lifecycle and the manufacturers need to update CER based on ongoing clinical evaluations. The CER can also be updated as the component of post-market surveillance and vigilance case review.
Major components of Clinical Evaluation Report
- Description of the medical device, components and model numbers
- Intended purpose of the device
- Fundamental principles of operation
- Indications and supporting claims
- Overview of relevant pre-clinical data
- State Compliance to standards like MEDDEV 2.7.1
Relevant Standards and Guidelines for Clinical Evaluation
The key applicable guidance standards and the respective guidelines are mentioned below;
- MEDDEV 2.7.1 Rev4, an updated version of Rev 3 standard provides the European Commission’s Guidelines on Medical Devices, which is a complete guide for manufacturers and regulatory authorities, relating to clinical data evaluation.
- MEDDEV 2.7.1 Rev3 standard provides the European Commission’s Guidelines on Medical Devices, which is a complete guide for manufacturers and regulatory authorities relating to clinical data evaluation.
- MEDDEV 2.12-1 Rev8 standard outlines the guidelines on medical device vigilance system.
- MEDDEV 2.12/2 Rev 2 provides the guidelines on medical devices relating to post –market clinical follow-up studies.
Medical device manufacturers need right expertise, and sufficient time to effectively conduct a clinical evaluation and subsequently create a clinical Evaluation Report (CER), thus it is a major challenge. Hence, many manufacturers’ have realized that the clinical evaluation process is not a standalone activity but a relatively continuous process and often seek the assistance of qualified professional service providers with strong expertise and experience to prepare an up to date CER.
Contact us for more information about how we can help you comply with MEDDEV 2.7/1 rev 4 and perform literature reviews.
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