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EU MDR
Clinical Evaluation

Have a team of experts to help you through the uncertain path of EU MDR clinical evaluation. We have gone through the path and have seen the pitfalls.

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We can customize our service to fit your needs. Small projects to comprehensive package, just name it!

We have a comprehensive MDR readiness checklist built on the experience of updating a plethora of clinical evaluation documents to MDR requirements. Our expert consultants have worked for top medical device manufacturers and have seen first-hand MDR transition of devices in various specialties and classes.

From this extensive experience, we have developed a 156-point assessment that are updated with latest guidances and findings from actual audits and reviews of clinical modules.

It is essential that the key strategic elements of MDR clinical evaluation are clearly defined from the planning stage.

Is there an equivalent device to be considered? Is there an ample body of literature available for both the subject device and state of the art devices? Is the device a “well-established technology”? Are indications and intended purpose well defined? Are contraindications clearly stated and applicable to the use of the subject device? Coming up with an appropriate strategy is half the battle.

Clinical evaluation documents, such as CEP and CER, used to be relatively brief and was not under a rigorous review.

However, with MDR, in some cases, these documents can be as much as tens or hundreds of pages long. If you need a second set of eyes or a completely new template, we can help!

The required documents and their interdependency with each other have created an increased workload and complexity in clinical evaluation process.

From CEPs to SSCPs, it is essential that the clinical evaluation documents are synchronized to demonstrate that the process has been adequately updated to the MDR requirements. From the planning stage to wrapping up SSCPs, we can provide a coherent service to update the documents in synchrony.

The most time consuming and complex element in MDR clinical evaluation is literature review, screening, and data management. There needs to be robust processes in place to ensure that clear records of every step of literature review and screening are kept and presented.

A strong background in scientific research and data analysis is key to performing these tasks efficiently. Our experts provide just that!

It is important to have a coherent story from CEP to SSCP. Any discrepancy can lead to deficiencies and costly rework.

Although CEPs tend to be shorter and straightforward, what goes in a CEP dictates the whole process of clinical evaluation and the outcomes presented in the final CER. It is essential that much consideration be given in the planning stage to ensure that an appropriate strategy is formulated before the CER is written.
With a right strategy formulated in the CEP, CER should faithfully follow what was prescribed in the CEP. With the overwhelming amount of information presented in the CER, it is easy to lose sight of the proposed plan and strategy. It is recommended that the sections between the CEP and the corresponding CER be aligned to make it easy to follow. In addition, the presentation in the CER should form an easy-to-follow story that the reviewer can easily understand.
With the conclusions of the CER, EU MDR specifically requires that any gap identified in clinical evidence be addressed through Post-Market Clinical Follow-up activities. There are many factors that will make PMCF activities more relevant, such as equivalence and severity and complexity of the indications. PMCF activities are proactive measures that will specifically address the gaps identified. It is not to be confused with post-market surveillance.
Summary of Safety and Clinical Performance is a public facing document that is designed to clearly inform the HCPs and patients of the safety and clinical performance of the subject device. There are specific elements that must be present in the document. The added challenge of the patient section of a SSCP is the readability score. A valid method to demonstrate the readability of SSCPs must be in place.

Clinical Evaluation needs to align with regulatory, risk management, post-market surveillance, and labeling processes to ensure full compliance with EU MDR.