What is Clinical Evidence under EU MDR?

07 November 2025 07 November 2025 3 minutes read

Clinical Evidence under the EU Medical Device Regulation (MDR) refers to the clinical data and the results of clinical evaluation that pertain to a specific medical device, providing a sufficient amount and quality of information to allow a qualified assessment of whether the device is safe and achieves its intended clinical benefit(s) when used as intended by the manufacturer.linkedin+2

Definition and Scope

The formal definition under the EU MDR states that "clinical evidence" is the cumulative body of clinical data and results of clinical evaluations for a device, of a sufficient amount and quality, to support the safety and performance claims of the device as well as its benefit-risk ratio. This includes all types of clinical data, such as:orielstat+1

Outcomes and safety data from clinical investigations or trials
Published scientific literature and reports
Post-market surveillance data, including post-market clinical follow-up activities

Purpose in EU MDR

The core purpose of clinical evidence is to demonstrate that the medical device is safe, performs as intended, provides measurable clinical benefits, and meets the General Safety and Performance Requirements (GSPRs) outlined in Annex I of the MDR. Every medical device—including low-risk devices—must be supported by appropriate clinical evidence.educolifesciences+2

For Class III and implantable devices, clinical investigations are almost always required, except in specific justified circumstances.decomplix
For lower-risk devices, comprehensive literature reviews and post-market data may be sufficient, but a Clinical Evaluation Report (CER) is always required.decomplix

Documentation Requirements

Manufacturers must develop and maintain several critical documents as part of the clinical evaluation process:

Clinical Evaluation Plan (CEP)
Clinical Evaluation Report (CER)
Post-Market Clinical Follow-up (PMCF) Plan and PMCF Report

These documents are living records, updated throughout the device’s lifecycle to reflect new post-market data and ongoing clinical evaluations.decomplix

Regulatory Impact

Robust clinical evidence is essential for obtaining CE marking for medical devices, as it enables conformity with MDR requirements and justifies the manufacturer's safety and performance claims. Failure to provide sufficient clinical evidence can prevent a device from entering or remaining on the EU market.medinstitute

In summary, under EU MDR, clinical evidence is the foundation for demonstrating that a medical device is safe, effective, and compliant with all regulatory requirements throughout its lifecycle.linkedin+3

Sources

Turkish Medical Index - Footer