Clinical Evaluation for Medical Devices

What is Clinical Evaluation?

The Clinical Evaluation a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use.

The requirements for clinical evaluation apply to all classes of medical devices. The evaluation should be appropriate to the device under evaluation, its specific properties, and its intended purpose. Benefits and risks should be specified, e.g. as to their nature, probability, extent, duration and frequency. Core issues are the proper determination of the benefit/risk profile in the intended target groups and medical indications, and demonstration of acceptability of that profile based on current knowledge/ the state of the art in the medical fields concerned.

Clinical Evaluation for Medical Devices as per EU MDR includes:

Clinical Evaluation Plan

A Clinical Evaluation Plan defines how the clinical evaluation will be conducted, including the methods, data sources, and objectives used to demonstrate that the device is safe and performs as intended.

Clinical Evaluation Report

A Clinical Evaluation Report (CER) is a key document in the clinical evaluation process that demonstrates the safety and effectiveness of a medical device. A well-prepared clinical evaluation report medical device includes data from clinical studies, technical documentation, and relevant scientific literature to support the device’s performance and safety. As part of medical device clinical evaluation, it also compares existing data from equivalent or similar devices to assess clinical performance evaluation and potential benefits. Whether you're launching a new product or updating an existing one, a strong MDR clinical evaluation is essential to prove compliance and ensure the device can be safely placed on the market.

Demonstration of Equivalence

In medical device clinical evaluation, demonstrating equivalence allows manufacturers to use clinical data from a similar device to support their own device’s safety and performance. This strategy is especially effective when preparing a clinical evaluation report for a medical device under EU MDR requirements. By referencing an equivalent device, you can strengthen your clinical performance evaluation without conducting entirely new clinical investigations. This approach streamlines the MDR clinical evaluation process, helping manufacturers meet regulatory requirements faster and with less effort, while ensuring a thorough and compliant clinical evaluation.

Literature Search Protocol & Report

A literature search protocol defines the search criteria, a scientific method for appraisal of literature. A literature search report compiles all literature safety, performance and evaluator conclusions.

Clinical Evaluation Report (CER) Writing for Medical Devices as per EU MDR

We provide expert support in clinical evaluation report writing for medical devices, ensuring full alignment with MDR clinical evaluation requirements. Our CER writers are subject matter experts who analyze clinical data from published literature, and research to assess the safety, performance, and clinical benefit of your device. Each clinical evaluation report demonstrates how the device meets GSPR, supports its benefit-risk profile, and includes clinical performance evaluation and post-market surveillance (PMS) activities. Whether you need initial or ongoing medical device clinical evaluation, our team ensures your documentation is clear, compliant, and audit-ready.

Clinical Evaluation Matters Under MDR 2017/745 Technical Documentation?

Clinical evaluation is a core part of the technical documentation required under EU MDR 2017/745. If you’re aiming for CE marking, you need a clear, evidence-backed Clinical Evaluation that shows your device is safe, effective, and performs as intended.

MDR clinical evaluation documents need to comply with below requirements:

Provide the evidence for relevant general safety and performance requirements.
Evaluation of product undesirable side-effects and acceptability of benefit-risk ratio based on clinical data.
Justify the level of clinical evidence necessary to demonstrate conformity with relevant general safety and performance requirements

Our CER writing team will prepare the complete clinical evaluation documents in compliance with the requirements of EU MDR 2017/745.

Frequently Asked Questions

Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.

The Clinical Evaluation Plan (CEP) outlines the methodology, objectives, and sources of data that will be used to conduct the clinical evaluation of a medical device. It serves as a roadmap for the evaluation process. The Clinical Evaluation Report (CER), on the other hand, is the final document that presents the results of the evaluation, including analysis of clinical data, demonstration of equivalence, safety and performance conclusions from referred literatures.

The device manufacturer is responsible for conducting the clinical evaluation. This evaluation must be carried out by individuals who are qualified in both the clinical application of the device and the applicable regulatory framework. Under the MDR.

The timeline for preparing a Clinical Evaluation Report (CER) depends on the device’s risk class, the amount of clinical data available, and the quality of existing documentation. On average, a well-structured CER under EU MDR 2017/745 takes 6 to 12 weeks to complete. This includes creating the Clinical Evaluation Plan (CEP), conducting systematic literature searches, analyzing clinical and post-market data, performing risk-benefit assessment, and compiling the final report.

Clinical Evaluation for Medical Devices

What is Clinical Evaluation?