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International Clinical Trials

Achieving Successful Clinical Evaluation Reports

Every medical device, whether it is an existing medical device on the market or a manufacturer launching a new product, needs to have an up-to-date clinical evaluation report (CER) as part of its technical file (irrespective of classification). Unless manufacturers have in-house CER specialists who can implement a comprehensive clinical evaluation strategy, the fundamental points of CER development and the steps which need to be taken to produce a successful and compliant CER are not always obvious.

The CER itself is a document that provides the notified body (NB) or other reviewers with adequate information to assess the appropriateness of the methodology, including data and overall conclusions. Not having the right expertise on hand to draft the CER means that various interpretations of the CER guidelines can occur. As the regulatory landscape evolves, the requirements CERs evolve too, making it more difficult for manufacturers to know if their approach to compliance is correct. The challenge to present properly supported CERs (particularly for devices that have faced safety issues in the past) is becoming tougher. However, failing to pass the CER could have drastic repercussions to some businesses, not only affecting where and how they can manufacture their products, but also impacting business reputation and, ultimately, the bottom line.

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Dr Efstathios Vassiliadis is a Solutions Delivery Manager at Maetrics, with experience in R&D, regulatory, technical writing, validation, and management in the medical device and pharmaceutical industry. He is an experienced leader directing large R&D, quality, regulatory, and management remediation and improvement programmes. Efstathios is a project lead and is currently supporting global remediation programmes for implementing new international regulatory requirements. Prior to Maetrics, Efstathios worked as director/head of department in both pharma and medical devices organisations, leading multi-disciplined projects from R&D to quality, production, technical, and management, covering almost the entire value chain.
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