Why There Is A Need For A Clinical Evaluation Report (CER) For Your Medical Devices?

 

Both the Medical Devices Directive 93/42/EEC (MDD) and the Medical Devices Regulation (EU) 2017/745 (MDR) require medical device makers to create a clinical evaluation for their products. A clinical evaluation's ultimate goal is to review and analyze clinical data about a medical device to offer proof of the product's clinical safety and performance. The review is based on pre and post-market clinical data relevant to the intended use of a device. Manufacturers may provide data relevant to the equipment being evaluated as well as data from comparable devices (where equivalence may be established).

A Clinical Evaluation Report (CER) is a complete summary of facts relevant to the clinical use of a medical device that has been evaluated. All clinical data sources are reviewed, as well as certain non-clinical testing data that may affect the device's benefit-risk analysis. When all of the information is considered together, it provides a comprehensive knowledge of the safety and effectiveness of your item for its intended purpose.

The clinical evaluation report is the clinical evaluation's output. Clinical evaluation is a continuous process that tracks a device's life cycle. This method is critical in the CE Marking of medical devices under MEDDEV 2.7/1, and the MDR. It is closely related to other critical aspects, such as Post-Market Surveillance (PMS) and Risk Management.

Why TRR?

At Thomas Regulatory Resolutions, we provide Clinical Evaluation Report Consultant services throughout the product development lifecycle. Our cross-functional engineers have regulatory and clinical knowledge, bringing contemporary industry requirements to light. This enhances their risk assessment skills, thereby expediting medical device idea development to clinical application in the safest possible manner. Similarly, our cross-functional regulatory and clinical professionals have front-end engineering development experience, which allows them to find efficiencies and avoid mistakes, resulting in faster product development.

Important Steps 

·         The overall strategy should include the following critical steps:

·         Identifying regulatory requirements that must be backed by clinical data

·         Identification of clinical data available for the product under assessment and the state of the art for the intended use

·         Determine whether there is enough clinical data for the safety and performance of the device under consideration.

·         If clinical data is insufficient, new clinical data will be generated.

·         Clinical safety and performance of the device, as well as the benefit/risk ratio.

Process

Risk management, design inputs, product specifications labeling or directions for use, pre-clinical research, clinical investigations, literature reviews, and PMS are all important inputs for clinical evaluation. The clinical evaluation results, namely clinical data on safety and performance, are then fed back into the risk/benefit analysis.

At Thomas Regulatory Resolutions, we develop clinical evaluation reports in collaboration with the manufacturer to provide a thorough picture of your device's clinical use. We gather and combine information from many sources to make sure the clinical evaluation report is thorough. TRR also provides you with the best FDA medical device consultant services that can match quality standards.

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