Medical Device CE Marking and the Importance of Clinical Evaluation

December 18, 2024: The MDR 2017/745, which came into full effect in May 2021, replaces the previous Medical Device Directive (MDD). It introduces more rigorous requirements to ensure the safety and efficacy of medical devices. One of the key aspects of MDR is the clinical evaluation of the throughout lifecycle. Article 61 of the MDR specifically mandates that manufacturers conduct clinical evaluations to confirm compliance and include it in the technical documentation.

This article provides a comprehensive overview of the crucial role that clinical evaluation plays in ensuring compliance with the Medical Device Regulation (MDR) for CE marking. The integration of systematic clinical assessments, as outlined in Article 61 of the MDR and supported by MEDDEV 2.7/1 Rev. 4, ensures the safety and performance of medical devices in the European market.

To market a medical device in the EU, it must bear the CE mark logo on the device’s primary and secondary packing which indicates compliance with MDR requirements. The clinical evaluation process is integral to obtaining this CE marking / EU MDR Certification from a Notified Body. Manufacturers must provide robust clinical evidence, including data from clinical investigations, scientific literature, and clinical experience. Article 61 of the MDR outlines the requirements and minimum supporting evidence.

Clinical Evaluation of Medical Devices

Medical device clinical evaluation is a systematic and planned process to continuously generate, collect, appraise, and analyse, clinical data about a medical device. This process aims to verify the safety and clinical performance of the device when used as intended. The evaluation must be documented in a Clinical Evaluation Report (CER), as per the guideline with all supporting evidence.

The clinical evaluation criteria outlined in MDR article 61 are still depending upon MEDDEV 2.7/1 Rev 4, in the absence of the respective MDCG guidance. It gives thorough guidelines on how to organize the CER, what information to include, and how to carry out a clinical evaluation.

The Clinical Evaluation Report (CER) is the conclusion of the clinical evaluation process arranged in an orderly and systematic fashion. It is a critical document in the technical documentation. The CER must be meticulously prepared, detailing the methodology, data sources, and results of the evaluation. The clinical evaluation must be done by an expert in the device usage.

The MDR mandates that the CER is not a one-time document but requires regular updates. This ensures that the clinical evidence remains current and reflects any new data or changes in the device’s use or performance. Annual updates to the CER are mandatory for class IIb and class III to demonstrate ongoing compliance.

Relevance of Literature Search Plan and Report in Clinical Evaluation

Soio George from I3CGLOBAL emphasized that the search report must include a clear and organized output of the literature search developed based on a literature search plan. He explained that relevant literature on the device under evaluation, equivalent device, benchmark, medical alternatives and similar devices should be included, clearly describing the purpose, method, and results of each literature evidence to ensure transparency and comprehensiveness in the clinical evaluation process. Literature data's relevance to the intended use, user population, use environment, patient population, and the safety and performance of the device under evaluation must be outlined. Additionally, current knowledge or the state of the art should be documented to facilitate a proper appraisal and analysis of the clinical data for the device and its equivalents. Any deviations from the search plan must be recorded in the search report.

Role of CER Writers

Clinical Evaluation documentation writers play a crucial and multifaceted role in the medical device clinical evaluation process, which is essential for ensuring the safety, performance, and compliance with medical devices' new regulations. Their responsibilities span from conducting comprehensive literature searches to evaluating clinical data, synthesizing findings, and ultimately preparing a detailed report. This process requires a deep and thorough understanding of the specific medical device being evaluated, its intended clinical application, and the underlying scientific principles that govern its functionality. In addition to this technical knowledge, CER writers must possess a solid grasp of regulatory requirements, such as those outlined in MEDDEV 2.7/1 Rev 4, MDR Article 61 and the relevant MDCG guidance, to ensure that all necessary clinical evidence is properly documented and analyzed in compliance with the guidance documents.

Clinical writers must also be skilled in scientific writing, crafting a report that is clear, accurate, and easy to understand for both technical and non-technical stakeholders. The CER must effectively demonstrate that the device meets the required safety and performance standards, making the CER writer a key contributor to the MDR CE Marking regulatory submission process.

Conclusion

The incorporation of the clinical evaluation process mandated by the MDR strengthens the stringent requirements for European CE Marking of medical devices. The meticulous compilation of comprehensive Clinical Evaluation Reports heavily depends on the expertise of experienced clinical writers from established firms like I3CGLOBAL

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