In the evolving landscape of medical device regulation, clinical evaluation has taken centre stage. With the introduction of the Medical Device Regulation (EU) 2017/745 (MDR), the requirements around clinical evaluations have been significantly reinforced compared to the old Medical Device Directive (MDD). Understanding and meeting these requirements is not just a legal necessity; it is critical for demonstrating the safety, performance, and clinical benefit of medical devices.
What is a Clinical Evaluation?
Clinical evaluation is a systematic and planned process to continuously generate, collect, analyse, and assess clinical data pertaining to a medical device. Its purpose is to verify the device’s safety and performance when used as intended.
Under the MDR, clinical evaluation is not a one-off event but an ongoing obligation throughout the device’s lifecycle. This continuous nature is a reflection of the MDR’s overarching goal: to ensure a high level of health protection for patients and users.
Why Has the Role of Clinical Evaluation Increased?
Several factors explain the heightened importance of clinical evaluation under the MDR:
- Stronger Emphasis on Clinical Evidence: Manufacturers must provide solid clinical evidence, especially for high-risk devices. Reliance on “equivalence” to other devices is much stricter, requiring direct access to technical documentation — often an impossible hurdle unless the equivalent device is owned by the same manufacturer.
- Lifecycle Approach: The MDR promotes a lifecycle approach to safety, requiring manufacturers to update clinical evaluations continuously, incorporating new data from post-market surveillance (PMS) and post-market clinical follow-up (PMCF).
- Tighter Scrutiny from Notified Bodies: Clinical Evaluation Reports (CERs) are subject to more rigorous review by Notified Bodies. Weak or outdated CERs are among the top reasons for delays or denials in gaining CE marking under the MDR.
- Patient Safety and Transparency: The MDR places patient safety and transparency at the core. Public access to summary clinical data for higher-risk devices through the EUDAMED database reinforces the need for robust clinical evaluation.
What are the Key Components of a Clinical Evaluation?
The clinical evaluation consists of two main documents, these include the following:
- Clinical Evaluation Plan: commonly abbreviated to CEP, the Clinical Evaluation Plan is the blueprint for how the clinical evaluation will be conducted. It defines the strategy, scope, objectives, and methods that will be used to gather and assess clinical evidence for the device.
- Clinical Evaluation Report: commonly abbreviated to CER, the Clinical Evaluation Report (CER) is a conclusive document that summarizes the results of the clinical evaluation according to the methods and scope defined in the CEP.
What makes a successful Clinical Evaluation?
Notified Bodies now expect a much higher standard of clinical evidence than was acceptable under the previous Medical Device Directive (MDD). Manufacturers must demonstrate not just that clinical data exists, but that it has been critically assessed, properly analysed, and that it robustly supports the safety, clinical performance, and benefit-risk profile of the device. Below are some important elements that make up a successful clinical evaluation.
- Proper Clinical Evaluation Plan: A properly prepared Clinical Evaluation Plan (CEP) is crucial. This plan must outline the strategy and methodology for gathering, appraising, and analysing clinical data. It must describe the scope of the evaluation, identify intended uses and populations, and define how existing and future clinical data will be considered, including post-market data. The plan must be realistic and faithfully followed throughout the evaluation, with any deviations explained and justified.
- Robust State-Of-The-Art Section: SOTA refers to the current and generally accepted standard of care, technologies, and clinical practices in the relevant medical field. It sets the benchmark against which a device’s safety and performance are evaluated. By clearly defining SOTA, manufacturers can demonstrate how their device compares to existing alternatives and justify the benefit-risk profile. To ensure accuracy and credibility, a structured and systematic literature search is essential. It provides a transparent, reproducible methodology for identifying relevant clinical data and guidelines, ensuring that the SOTA truly reflects the most current and comprehensive understanding of the medical landscape.
- Systematic Literature Review: The Clinical Evaluation must be based on a systematic literature review that is fully documented. It is not enough to merely cite articles; manufacturers must demonstrate a rigorous and reproducible search process, including databases searched, keywords used, and inclusion/exclusion criteria applied. Every study included must be critically appraised for its relevance, quality, and level of evidence. Studies that are weak or biased must be identified and weighted accordingly. If a device relies on equivalence to another device, equivalence must be proven with comprehensive technical, clinical, and biological comparisons — and only if the manufacturer has full access to the comparator’s technical documentation, which is rare in practice.
- Evidence Based: Another important requirement is a clear demonstration of clinical safety and clinical performance. The Clinical Evaluation must show, through evidence, that the device consistently achieves its intended purpose safely and effectively. Benefit-risk assessments must be realistic and based on clinical data, not hypothetical reasoning. Furthermore, the Clinical Evaluation must incorporate post-market surveillance (PMS) and post-market clinical follow-up (PMCF) data where available. Real-world evidence, complaint data, and vigilance reports must be critically reviewed and used to confirm the ongoing safety and performance of the device.
- Clear Structure: Finally, the Clinical Evaluation Report (CER) must be clearly structured, logical, and transparent. It must be easy for reviewers to follow the methods, findings, and conclusions, with traceable links between the data reviewed and the conclusions drawn. Manufacturers must avoid vague summaries and instead present a well-documented critical appraisal that supports every claim made about the device. A strong, scientifically justified Clinical Evaluation not only satisfies regulatory requirements but also builds confidence in the device’s safety and performance across the market.
Under the MDR, clinical evaluation is more than a regulatory checkbox — it is a fundamental demonstration of a device’s benefit-risk profile. Manufacturers who invest in a thorough, dynamic clinical evaluation process not only facilitate regulatory approval but also uphold patient safety and gain a competitive advantage in a market that increasingly demands transparency and accountability.
What are the most common mistakes seen in Clinical Evaluations?
- Over-reliance on literature without proper critical appraisal: Many manufacturers attempt to use published literature as the main source of clinical evidence, assuming that simply compiling papers is sufficient. However, the MDR requires a critical evaluation of each source’s relevance, quality, and applicability to the specific device.
- Assuming equivalence without direct access to technical documentation: Under the MDR, using clinical data from a “similar” device is much harder. Manufacturers often wrongly assume they can claim equivalence without full technical and clinical access to the comparator device.
- Neglecting post-market data in updates to the CER: Manufacturers often treat clinical evaluation as a “pre-market” activity only, forgetting that the MDR requires continuous updating based on real-world evidence aftermarket launch.
- Insufficiently linking clinical evidence to the device’s intended use: Clinical evidence sometimes does not clearly or fully support the device’s stated indications or claims made in the Instructions for Use (IFU), labelling, or marketing materials.
- Insufficient State-of-the-Art Section: Notified Bodies are increasingly scrutinizing SOTA sections. A weak or outdated SOTA may lead to delays or even rejection of conformity assessments
How Can Advena Help?
At Advena, our team of experienced consultants specializes in the development of comprehensive Clinical Evaluations in accordance with the requirements of the EU Medical Device Regulation (MDR).
Additionally, if you have recently undergone a Notified Body audit and deficiencies were identified in your Clinical Evaluation, we can provide expert support to address and close these gaps efficiently, ensuring full compliance with regulatory expectations.
For further information or to discuss your specific needs, please do not hesitate to contact us.
