Clinical Evaluation Plan

Clinical Evaluation Plan Requirements as per MDR 2017/745 Annex XIV part A:

• 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.

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.