Clinical evaluation is a cornerstone in the medical device industry, serving as a pivotal and ongoing process to systematically assess clinical data, ensuring the safety, performance, and regulatory compliance of medical devices throughout their lifecycle.
Clinical evaluation is indispensable in the realm of medical devices as it serves as a critical mechanism to ensure patient safety , demonstrate device efficacy in real-world scenarios, meet stringent regulatory requirements, support regulatory submissions, facilitate informed decision-making by healthcare professionals and regulatory bodies, adapt to the device's lifecycle through ongoing assessments, and build market confidence by providing a well-documented and scientifically supported evaluation of the device's safety and performance.
Our scope
Starodub team is experienced and qualified in conducting the clinical evaluation for class I-III medical devices, including implantable medical devices and software as medical devices.
Regulatory basis
Our team adheres to the following regulations and guidelines which conduct the clinical evaluation:
- Medical device regulation, specifically Article 61 and Annex XIV;
- MEDDEV 2.7/1 Rev. 4;
- MDCG 2020-5Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC A guide for manufacturers and notified bodies
- MDCG 2020-6Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC: A guide for manufacturers and notified bodies
Our approach
- Schedule:
Description : The process begins with a comprehensive plan outlining the key objectives, scope, and methodology for the clinical evaluation. This stage involves defining the relevant clinical questions, specifying the intended purpose of the device, and establishing the criteria for data collection and analysis.
Objective : To set a clear framework for the entire clinical evaluation process, ensuring it aligns with regulatory requirements and the specific characteristics of the medical device.
- Identification of Clinical Data
Description : This internship involves the systematic identification and collection of relevant clinical data. This may include data from literature, clinical investigations, post-market surveillance, and other relevant sources. The aim is to gather robust and pertinent information to address the predefined clinical questions.
Objective : To compile a comprehensive set of clinical evidence that supports the safety and performance of the medical device.
- Appraisal of Clinical Data:
Description : Once the data is collected, a thorough appraisal is conducted. This involves critical analysis and evaluation of the quality, relevance, and reliability of the clinical evidence. It includes an assessment of the study designs, methodologies, and any potential bias or confounding factors.
Objective : To ensure the credibility and validity of the clinical data, supporting the conclusions drawn during the clinical evaluation.
- Analysis and Synthesis:
Description : In this stage, the analyzed data is synthesized to draw conclusions regarding the safety and performance of the medical device. The evaluation considers factors such as patient populations, clinical outcomes, and the state of the art in relevant scientific and medical fields.
Objective : To derive meaningful insights and conclusions based on the compiled clinical evidence, addressing the predefined clinical questions.
- Clinical Evaluation Report (CER) Preparation:
Description : The findings from the analysis and synthesis are documented in a comprehensive Clinical Evaluation Report (CER). The CER provides a clear and transparent account of the clinical evaluation process, including the methodology, results, and conclusions.
Objective : To communicate the outcomes of the clinical evaluation in a structured and transparent manner, meeting regulatory requirements and facilitating regulatory submissions.
- Update and Iterative Process:
Description : Clinical evaluation is an ongoing process that requires periodic updates, especially when new data becomes available or when there are changes in the medical device, intended use, or regulatory landscape. The CER should be updated regularly throughout the device's lifecycle.
Objective : To ensure that the clinical evaluation remains current and reflective of the latest clinical data and knowledge, supporting continued regulatory compliance and market access.
This streamlined overview captures the essential stages in the clinical evaluation process as outlined in MEDDEV 2.7.1 Rev. 4.
Questions and answers
Question: What is the importance of clinical evaluation for medical devices?
Answer : Clinical evaluation is crucial for assessing the safety and performance of medical devices. It provides evidence to demonstrate that the device meets regulatory requirements and ensures patient safety throughout its lifecycle. The process involves gathering, analyzing, and synthesizing clinical data to draw conclusions about the device's efficacy and safety in real-world scenarios.
Question: How often should a clinical evaluation be updated?
Answer : Clinical evaluations should be dynamic and regularly updated. It's recommended to revisit the evaluation whenever new relevant clinical data becomes available or when there are changes to the device, its intended use, or the regulatory landscape. Regular updates ensure that the clinical evaluation remains current and aligned with the latest scientific and clinical knowledge.
Question: What are the key elements of a Clinical Evaluation Report (CER)?
Answer : A Clinical Evaluation Report (CER) typically includes the device's description, clinical data identification, appraisal of clinical data, analysis, synthesis, and conclusions. It also outlines the methodology used in the evaluation. The CER serves as a comprehensive document that communicates the clinical evaluation process, findings, and supporting evidence to regulatory authorities and stakeholders.
Employees
