Achieving Regulatory Compliance Through Clinical Evaluation

clinical evaluation blog

By Jasmin Hunter, Senior Consultant

Clinical evaluation is a process to collect and assess all clinical data relating to a device and to evaluate whether there is sufficient clinical evidence to demonstrate conformity to the relevant regulatory requirements, helping to ultimately achieve regulatory compliance. The process is first laid out in a Clinical Evaluation Plan (CEP) and the results are documented in a Clinical Evaluation Report (CER). Clinical evaluation is required for compliance to the EU MDR 745/2017, and it is also used for other regulatory agencies such as the Therapeutic Goods Administration (TGA) in Australia and Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.

Changes in the clinical evaluation process, initiated by MEDDEV 2.7/1 Rev 4 and further refined by the MDR 745/2017 have left many manufacturers struggling to meet growing clinical data requirements. Qserve is poised to help manufacturers in ways beyond writing clinical evaluations that will save time and increase the likelihood of success of Medical Device Regulation (MDR) submissions and regulatory compliance.

Sufficient Clinical Evidence Assessment

A large part of achieving sufficient clinical evidence for MDR is being able to quantify the clinical benefit of a medical device. This can be particularly troublesome for legacy devices that have a long history of clinical evaluation in which benefits were cited from literature. Quantifying clinical benefit requires defining clinical outcome parameters (also referred to as ‘endpoints’) for clinical aspects of performance and safety. Our experts at Qserve and Qserve CRO can help you identify relevant clinical outcome parameters to use as well as cost-effective and time-efficient ways to collect data for your device. We can also evaluate available data to ensure there is sufficient evidence to support all variants of the device, accessories, patient populations, and indications for use.  Once the data is evaluated, we can recommend the best clinical strategy for submission, whether that is Article 61(10), indirect clinical benefit (MDCG 2020-6 section 6.5), equivalence, well-established technology, or clinical study.

Literature Search Design

At Qserve, our experts have a combined experience of over 25 years in literature search design.  We have developed our own methodology to identify relevant literature for clinical evaluation with a reasonable workload in terms of appraisal and data extraction. We have also developed our documentation specifically for systematic literature reviews that reduces Notified Body (NB) questions. Our team can help you design your literature search ensuring that all relevant aspects of state-of-the-art are considered. We can guide you through the appraisal process to reduce non-specific data that does not add value to the clinical evaluation.

Notified Body Responses

Notified Body questions have followed the requirements put forth in MDCG 2020-13.

While there has been variability in interpretations of some of the requirements amongst NBs, the template in large part keeps most reviewers focused on key aspects required for systematic literature reviews and sufficient clinical evidence assessments that were not always scrutinized under the Medical Device Directive (MDD). The result is a wide array of questions related to the clinical evaluation, IFU, marketing material, SSCP, and PMCF documents that manufacturers struggle to answer. NB queries may require a tight timeline for response and an update of the clinical evaluation documents especially with multiple technical file reviews taking place in a short period of time. The responses require dedicated resources including a resource with clinical knowledge on the use of the device, associated medical field, and proper documentation for a systematic literature review. Even if Qserve did not help you with the clinical evaluation under review, we can help you answer NB questions effectively, reducing time for approval and reducing the risk of rejection.

Training

Our team at Qserve and Qserve CRO prides ourselves on our comprehensive training suites that enable manufacturers to move forward with future applications. We offer training on everything from writing a clinical evaluation to conducting a systematic literature review. We can even teach you how to effectively answer NB questions. We are flexible enough to allow custom training – we can train your team as we work on a clinical evaluation together or we can train aspects as your team works through the process. We can also train your cross-functional team responsible for management of all documentation related to MDR Article 10. This training provides insight into how decisions made for all documentation required for Article 10 can impact the success of a clinical evaluation.

Our team of experts at Qserve and Qserve CRO specializes in MDR submissions and can help you achieve regulatory compliance through clinical evaluation. Contact us to learn how we can help you.

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