Clinical Evaluation for Medical Devices

1. Clinical Evaluation for Medical Devices www.mavenprofserv.com

2. Introduction to Clinical Evaluation Clinical evaluation is crucial for all medical devices, regardless of risk class. It's deeply connected to risk management and post-market surveillance, ensuring device safety, effectiveness, and compliance. 1 2 3 Regulatory Landscape Clinical Data Clinical Investigation Familiarize with MDR regulations and key terminology. Gather and analyze existing clinical data from various sources to form the foundation of the evaluation. Conduct new investigations only after analyzing existing data to avoid unnecessary trials.

3. What is Clinical Evaluation? Clinical evaluation is the continuous review and analysis of clinical data using scientific methods to assess a medical device's safety and performance for its intended use. Continuous Process Key Deliverable MDR Alignment Begins during development and continues throughout the device's lifecycle. The Clinical Evaluation Report (CER) documents safety and efficacy. Essential for regulatory compliance under MDR requirements. A well-prepared CER includes data analysis, risk-benefit assessment, and literature review to support continued device use and regulatory compliance.

4. Why Clinical Evaluation Matters Under MDR Clinical evaluation is a core part of the technical documentation required under EU MDR 2017/745 for CE marking. Validates Claims Interlinked with Risk Management Ongoing Evaluation Ensures safety, performance, and clinical benefit claims are backed by solid, verifiable data from various sources. Requires active data gathering and assessment post-market through PMS and PMCF for long-term compliance. Helps identify, assess, and address potential safety and performance concerns, strengthening patient safety.

5. Key Steps Before Clinical Investigation Before any clinical investigation begins, several crucial steps must be completed to ensure thoroughness and alignment with regulatory standards. Establish Safety & Performance Claims Perform Risk Assessment Define Intended Use Use a benefit-risk analysis tailored to the device's intended use to support claims. Conduct a comprehensive risk assessment in line with MDR requirements. Clearly specify the device's purpose and target patient population.

6. Breaking Down the Clinical Evaluation Process Clinical evaluation involves an ongoing, structured review of clinical data to confirm device safety, performance, and health benefits throughout its lifecycle. • Understanding Regulatory Requirements • Identifying Equivalent Devices • Appointing a Qualified Clinical Evaluator • Scientific Literature Search • Interpretation of Preclinical Data • Collecting Sufficient Clinical Data • Defining State of the Art • Compiling Technical Documentation • Post-Market Clinical Follow-Up (PMCF) & Surveillance

7. Essential Clinical Evaluation Documents These documents are crucial for demonstrating device safety and performance, ensuring MDR compliance. 1 2 Clinical Evaluation Plan (CEP) Literature Search Protocol & Report Defines how the clinical evaluation will be conducted, including methods, data sources, and objectives. Gathers evidence on safety and performance by reviewing existing clinical data and scientific research. 3 4 Clinical Evaluation Report (CER) Demonstration of Equivalence Key document demonstrating device safety and effectiveness, including data from studies and literature. Allows use of clinical data from a similar device to support your own device's safety and performance.

8. Our Expertise: CER Writing for MDR-Compliant Devices We provide expert support in clinical evaluation report writing, ensuring full alignment with MDR clinical evaluation requirements. Subject Matter Experts GSPR Alignment Audit-Ready Documentation Our CER writers analyze clinical data from various sources to assess device safety and performance. Each CER demonstrates how the device meets General Safety and Performance Requirements. We ensure your documentation is clear, compliant, and ready for audits and approvals. Our team guides you through the process, from audits to certification, enabling faster approvals and patient-first outcomes.

9. Contact Us https://mavenprofserv.com/preparation-clinical-evaluation-medical-device/ business@mavenprofserv.com enquiry@mavenprofserv.com