Clinical Evaluation Plan and its Purpose as per EU MDR
A Clinical Evaluation Plan (CEP) is the foundational document to perform clinical evaluation of any medical device. A Clinical Evaluation plan defines the scope of the evaluation, the approach and outlines the process for recording and measuring outcomes.
Creating a Clinical Evaluation Plan (CEP) ensures a structured approach to the clinical evaluation and ensures a rational approach in determining an effective way to determine the clinical safety and use of the medical device. It standardizes technical file preparation activities, guiding them towards drafting a purposeful and successful Clinical Evaluation Report (CER).
For Medical Devices Manufacturers, seeking CE Certificate as per EU MDR (MDR 2017/745), the Clinical Evaluation Plan (CEP) is one of the requirement which has to be ensured. Data is crucial in a Clinical Evaluation Plan (CEP), and it must outline the plan as it helps medical device manufacturer to identify, appraise, and analyze relevant clinical data. It helps medical device manufacturers to meet General Safety and Performance Requirements (GSPR), including the literature search protocol for any clinical data referred/analyzed and supports the clinical evaluation report.
- General Safety and Performance Requirements (GSPR): Identify the requirements (Annex I of MDR) that need clinical data support.
- Intended Purpose and Target Groups: Define the device’s purpose, target groups, indications, and contraindications.
- Data Analysis and Conformity Assessment: Outline the aspects needed for clinical data analysis and conformity assessment.
- Clinical Benefits and Outcome Criteria: Specify the intended clinical benefits and relevant outcome criteria.
- Evaluation Methods: Detail methods for evaluating qualitative and quantitative clinical safety, residual risks, and side effects.
- Benefit-Risk Ratio: Specify criteria for determining the acceptability of the benefit-risk ratio based on the state-of-the-art.
- Specific Components: Address how to handle benefit-risk related to any medicinal substances or animal/human tissues in the device.
- Data Collection Technique: Indicate the technique for clinical data collection (equivalent device data, device under evaluation data, or scientific literature).
- Clinical Development Plan: Include a plan indicating the progress from exploratory to confirmatory investigations and post-market clinical follow-up, with milestones and acceptance criteria.
- Clinical Evidence Level: Determine the level of clinical evidence required to demonstrate conformity with general safety and performance requirements.
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Clinical Evaluation Plan Requirements as per MEDDEV 2.7/1 Rev.4 Guidance:
- Device Description and Intended Purpose: Define the medical device, its intended use, target groups, and indications requiring special attention for safety and performance.
- Application and Safety Claims: Specify the device’s application, target treatment group, proposed warnings, contraindications, precautions, and application method. Include any specific claims made by the manufacturer about the clinical safety and performance of the device.
- Residual Risk and Equivalence: Identify any residual risks with clinical significance and provide information needed for the evaluation of equivalence if claimed.
- Relevant Standards and Guidelines: Reference relevant standards and guidelines, current knowledge, state of the art, and available medical alternatives for the target population.
- Data Sources and Types: Detail the sources and types of data to be used in the clinical evaluation, including both pre-CE marking and post-CE marking stages.
The clinical evaluation plan should be clearly identified in the technical file of your medical device. It can be presented as a separate document or as part of the clinical evaluation report (CER). By incorporating the requirements as per MEDDEV 2.7/1 Rev. 4 guidance document and MDR 2017/745, the CEP ensures compliance with EU MDR, helping achieve CE marking for your medical devices.
EU MDR Clinical Evaluation Plan Requirements
Under the EU MDR (2017/745), a Clinical Evaluation Plan (CEP) is essential for demonstrating the clinical safety and performance of a medical device. It ensures compliance with General Safety and Performance Requirements (GSPR) and provides a structured approach to evaluating clinical data. The CEP outlines the intended purpose, target groups, benefit-risk analysis, and methods for data collection and analysis. Using a well-prepared clinical evaluation plan template simplifies the process, ensuring adherence to Annex XIV Part A and MEDDEV 2.7/1 Rev. 4 guidelines. This is a crucial step for manufacturers seeking CE marking for their medical devices.
The EU MDR Clinical Evaluation Plan Template
The EU MDR Clinical Evaluation Plan Template is a practical tool designed to help medical device manufacturers prepare a clear and structured Clinical Evaluation Plan (CEP) in line with MDR 2017/745 requirements. This template covers all the essential elements, such as General Safety and Performance Requirements (GSPR), benefit-risk analysis, and clinical evidence levels. It simplifies the process by guiding manufacturers on how to define the intended purpose, evaluate clinical data, and plan post-market follow-ups. By using a clinical evaluation plan template, manufacturers can ensure their clinical evaluation plan MDR is thorough, compliant, and ready to support CE marking.
MAVEN can be your go-to for a comprehensive clinical evaluation plan. Our expert team can assist with clinical writing for your Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER), ensuring they meet all global standards. You can also purchase our detailed clinical evaluation plan templates directly from our website. These templates cover all the essential aspects required for clinical evaluation, helping you achieve compliance with EU MDR, CE Marking, and other regulatory requirements. Let MAVEN simplify your path to CE Marking with a robust clinical evaluation plan.
