---
title: "Clinical Evaluation for Medical Devices Under MDR"
description: "Clinical evaluation is central to demonstrating the safety, performance and clinical benefits of your medical device under the MDR. Discover how to build a robust clinical evaluation strategy, prepare your CEP and CER, and generate the clinical evidence needed throughout the device lifecycle. Strengthen your clinical documentation and prepare with confidence for CE marking."
url: https://qbdgroup.com/en/whitepapers/clinical-evaluation-for-medical-devices-under-mdr
type: "White paper"
language: en
published: 2025-01-05
category: "Clinical"
publisher: "QbD Group"
citation: "QbD Group, \"Clinical Evaluation for Medical Devices Under MDR\", https://qbdgroup.com/en/whitepapers/clinical-evaluation-for-medical-devices-under-mdr"
---
# Clinical Evaluation for Medical Devices Under MDR
> Clinical evaluation is central to demonstrating the safety, performance and clinical benefits of your medical device under the MDR. Discover how to build a robust clinical evaluation strategy, prepare your CEP and CER, and generate the clinical evidence needed throughout the device lifecycle. Strengthen your clinical documentation and prepare with confidence for CE marking.

Clinical evaluation is central to demonstrating the safety, performance and clinical benefits of your medical device under the MDR.

Discover how to build a robust clinical evaluation strategy, prepare your CEP and CER, and generate the clinical evidence needed throughout the device lifecycle.

Strengthen your clinical documentation and prepare with confidence for CE marking.

![Clinical Evaluation for Medical Devices Under MDR](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/white-papers/clinical-evaluation-mdr-content.png)

## About This White Paper

Under the MDR, clinical evaluation is an ongoing process of collecting, generating, appraising and analysing clinical data to demonstrate the safety, performance and clinical benefits of a medical device. It plays a central role in obtaining and maintaining market approval in the EU.

This white paper guides you through the key elements of clinical evaluation under MDR 2017/745 and MEDDEV 2.7/1 Rev. 4, from establishing your clinical strategy and preparing a Clinical Evaluation Plan (CEP) to compiling and maintaining a Clinical Evaluation Report (CER).

It also explores state-of-the-art assessments, literature reviews, equivalence, pre-clinical and clinical data, PMS and PMCF, risk assessment, and some of the most common gaps that can jeopardise a successful clinical evaluation.

## Key Takeaways

✓ Understand the Role of Clinical Evaluation Under MDR. Learn how clinical evaluation demonstrates the performance, safety and clinical benefits of your device, and how clinical evidence from literature, clinical investigations and PMS contributes to this assessment.

✓ Start Your Clinical Evaluation Early. Discover why clinical evaluation should begin during development and continue throughout the device lifecycle, and how an early gap analysis can identify missing data and the potential need for clinical investigations.

✓ Know When to Update Your Clinical Evaluation. Understand how PMS and PMCF data feed into clinical evaluation after market introduction and how update frequency depends on device risk classification and newly available information.

✓ Build a Strong Clinical Evaluation Plan. Learn how the CEP acts as the roadmap for your clinical evaluation strategy, defining its scope, data sources, assessment methods, clinical benefits, risks and relevant safety and performance requirements.

✓ Develop a Robust Clinical Evaluation Report. Explore how the CER brings together state-of-the-art, pre-clinical, clinical and post-market data to draw conclusions about device safety, performance, usability and benefit-risk acceptability.

✓ Get Your State-of-the-Art and Literature Review Right. Understand how benchmark devices, alternative treatments and clinical literature help establish appropriate safety, performance and benefit-risk criteria, and why your literature search needs to be comprehensive, objective and reproducible.

✓ Understand the Stricter Requirements for Equivalence. Learn why relying on an equivalent device has become significantly more challenging under MDR and what technical, biological and clinical characteristics need to be considered.

✓ Connect Clinical Evaluation With PMS, PMCF and Risk Management. See how post-market data, clinical risks, residual risks and clinical benefits feed back into the CER to continuously confirm the safety, performance and acceptable benefit-risk profile of your device.

✓ Avoid Common CER Gaps and Hurdles. Identify frequent issues such as weak literature reviews, missing supporting documents, inconsistencies between the CER and IFU, and insufficient multidisciplinary input.
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Source: https://qbdgroup.com/en/whitepapers/clinical-evaluation-for-medical-devices-under-mdr — © QbD Group. Quote freely with attribution and a link back.