Description
This ready-to-use CEP template provides a comprehensive and methodical approach to planning and executing clinical evaluation, ensuring safety, performance, and compliance with MDR and MEDDEV 2.7/1 Rev.4 requirements.
With a well-defined clinical evaluation process, this template helps manufacturers, regulatory professionals, and clinical teams systematically collect, assess, and analyze clinical data to demonstrate the device’s benefit-risk profile and compliance with General Safety and Performance Requirements (GSPRs).
📌 What’s Inside the Clinical Evaluation Plan Template?
1️⃣ Introduction – Overview of the Clinical Evaluation Plan (CEP), its purpose, and its role in regulatory compliance.
2️⃣ Scope – Defines the objectives of the clinical evaluation and its application in the device’s conformity assessment process.
3️⃣ Clinical Evaluation Team – Description of the team responsible for clinical evaluation, their qualifications, and roles in the assessment process.
4️⃣ Medical Device Under Evaluation – General information about the device, including intended purpose, classification, and technological characteristics.
5️⃣ Current Knowledge and State of the Art Data Search & Selection Protocol
- Identification of the current state of the art and clinical background.
- Search strategy and methodology, including PICO process, data sources, filters, and selection criteria.
- Identification of key search keywords to ensure relevant data collection.
6️⃣ Equivalence Assessment – Evaluation of technical, biological, and clinical equivalence in accordance with MDR.
- Comparison with competitor devices and assessment of similarities and differences based on established equivalence criteria.
7️⃣ Pivotal Data Search – Methodology for identifying key clinical data necessary to support the device’s safety and performance claims.
8️⃣ GSPRs Requiring Clinical Data – Identification of General Safety and Performance Requirements (GSPRs) that necessitate clinical evidence.
9️⃣ Intended Clinical Benefits & Clinical Claims – Definition of the clinical benefits and performance claims of the device, based on clinical evidence.
🔟 Parameters for the Acceptability of the Benefit-Risk Ratio – Establishment of criteria for assessing the benefit-risk profile in accordance with MDR requirements.
1️⃣1️⃣ Post-Market Clinical Follow-Up (PMCF) – Integration of PMCF activities within the clinical evaluation plan to continuously monitor safety and performance.
1️⃣2️⃣ Clinical Development Plan – Outlines how additional clinical data will be generated, including plans for future clinical studies if required.
✅ Why Choose This Template?
✔️ Fully Compliant with EU MDR 2017/745 & MEDDEV 2.7/1 Rev.4 – Structured to align with the latest regulatory requirements.
✔️ Comprehensive & Systematic Approach – Ensures a methodical and reproducible clinical evaluation process.
✔️ Saves Time & Reduces Compliance Risks – Avoid missing critical regulatory requirements and streamline the CE-marking process.
✔️ Editable & Customizable – Delivered in an easy-to-edit format, allowing adaptation to any medical device and clinical strategy.
