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 Regulatory Landscape Familiarize with MDR regulations and key terminology.
2 Clinical Data Gather and analyze existing clinical data from various sources to form the foundation of the evaluation.
3 Clinical Investigation Conduct new investigations only after analyzing existing data to avoid unnecessary trials.
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 Begins during development and continues throughout the device's lifecycle.
Key Deliverable
The Clinical Evaluation Report (CER) documents safety and efficacy.
MDR Alignment 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.
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
Ensures safety, performance, and clinical benefit claims are backed by solid, verifiable data from various sources.
Interlinked with Risk Management
Helps identify, assess, and address potential safety and performance concerns, strengthening patient safety.
Ongoing Evaluation
Requires active data gathering and assessment post-market through PMS and PMCF for long-term compliance.
Key Steps Before Clinical Investigation
Before any clinical investigation begins, several crucial steps must be completed to ensure thoroughness and alignment with regulatory standards.
Define Intended Use
Clearly specify the device's purpose and target patient population.
Perform Risk Assessment
Conduct a comprehensive risk assessment in line with MDR requirements.
Establish Safety & Performance Claims
Use a benefit-risk analysis tailored to the device's intended use to support claims.
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
• Appointing a Qualified Clinical Evaluator
• Interpretation of Preclinical Data
• Defining State of the Art
• Identifying Equivalent Devices
• Scientific Literature Search
• Collecting Sufficient Clinical Data
• Compiling Technical Documentation
• Post-Market Clinical Follow-Up (PMCF) & Surveillance
Essential Clinical Evaluation Documents
These documents are crucial for demonstrating device safety and performance, ensuring MDR compliance.
1
Clinical Evaluation Plan (CEP) Defines how the clinical evaluation will be conducted, including methods, data sources, and objectives.
3
Clinical Evaluation Report (CER) Key document demonstrating device safety and effectiveness, including data from studies and literature.
2 Literature Search Protocol & Report Gathers evidence on safety and performance by reviewing existing clinical data and scientific research.
4 Demonstration of Equivalence Allows use of clinical data from a similar device to support your own device's safety and performance.
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
Our CER writers analyze clinical data from various sources to assess device safety and performance.
GSPR Alignment
Each CER demonstrates how the device meets General Safety and Performance Requirements.
Audit-Ready Documentation
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 patientfirst outcomes.
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