Clinical Evaluation

What is Clinical Evaluation?

Clinical evaluation is the systematic process of assessing clinical data to verify the safety, performance, and benefits of a medical device. Under the European Medical Device Regulation (EU MDR 2017/745), it is a mandatory requirement for all medical devices, regardless of their risk class.
In the United States, under the FDA regulation, while terminology differs, clinical evidence is also required for market approval or clearance.
The outcome of this process is documented in the Clinical Evaluation Report (CER), which forms part of the device’s technical documentation submitted to Notified Bodies and Competent Authorities.
A robust clinical evaluation typically follows these key steps:

Regulatory Context

EU MDR 2017/745: Requires manufacturers to plan, conduct, and update clinical evaluations throughout the device lifecycle.MDCG Guidance Documents: The Medical Device Coordination Group issues practical guidance on applying MDR requirements, including clinical evaluation (e.g., MDCG 2020-13 on equivalence and MDCG 2020-6 on sufficient clinical evidence).MEDDEV 2.7/1 rev. 4: Although predating MDR, it remains a widely used reference for methodology and clinical evaluation principles.ISO 13485 & ISO 14155: Define quality management requirements and good clinical practice for device investigations.21 CFR Part 807 - 510(k) Submissions: states that clinical data may be required when a device presents new technology, new indications, or insufficient bench/lab evidence.21 CFR Part 814 - Premarket Approval (PMA): For high-risk devices (Class III), clinical studies are usually mandatory. The PMA application must provide valid scientific evidence of safety and effectiveness.FDA Guidance Documents: “Deciding When to Submit Clinical Data for a 510(k)” – clarifies when clinical evidence is needed.

Sources of Clinical Data

Continuous Updates

Clinical evaluation is not a one-off exercise. It must be continuously updated with data from post-market activities, vigilance, and ongoing clinical studies. The update frequency depends on the risk class, device history, and emerging safety or performance information.

Challenges and Best Practices

How We Can Help

We support manufacturers in developing robust clinical evaluations by providing:● Clinical Evaluation Plans (CEP)● Systematic literature reviews● Clinical Evaluation Reports (CER)● Strategies for PMS and PMCF integration
Our expertise ensures that your documentation meets MDR and international requirements, while demonstrating the safety and performance of your medical device.