Glossary · EU medical devices: MDR
Clinical evaluation (MDR)
Also known as: MDR clinical evaluation, Clinical evaluation report (CER)
Under the EU Medical Device Regulation (EU) 2017/745, clinical evaluation is the systematic and planned process to continuously generate, collect, analyze and assess the clinical data on a device in order to verify its safety and performance, including its clinical benefits, when used as intended. It is required for every device class, follows Article 61 and Annex XIV Part A and is documented in a clinical evaluation report.
- EU
- MDR
- Technical documentation
In one sentence
Clinical evaluation under MDR Article 61 and Annex XIV: the planned, continuous assessment of clinical data on a device’s safety and performance.
Example
A manufacturer of a class IIb bone screw writes a clinical evaluation plan, appraises published studies and its own PMCF data, and concludes in the clinical evaluation report that the benefit-risk ratio is acceptable for the stated indications.
How it applies
- Plan first: The evaluation starts from a clinical evaluation plan that names the relevant general safety and performance requirements, the intended purpose, target groups, clinical benefits and the parameters used to judge the benefit-risk ratio against the state of the art.
- Data sources: Clinical data can come from clinical investigations of the device, from published literature on the device or an equivalent device, and from post-market clinical follow-up. Each source is appraised for relevance and quality.
- Equivalence: Claiming equivalence to another device requires showing technical, biological and clinical equivalence and, under the MDR, sufficient access to the data of that device. MDCG 2020-5 explains the expectations.
- Class III and implantable devices: As a rule these need clinical investigations of the device itself; Article 61 lists the exceptions. MDCG 2020-6 covers sufficient clinical evidence for legacy devices.
- Lifecycle: The evaluation is not a one-off. It is updated with post-market surveillance and PMCF data throughout the life of the device.
- Technical documentation: The clinical evaluation report is part of the technical documentation under Annex II and is reviewed by the notified body for devices above class I. For implantable and class III devices it feeds the SSCP.
Clinical evaluation vs. clinical investigation
Clinical evaluation is the overall assessment of all available clinical data, done for every device. A clinical investigation is one way to generate such data: a study in human subjects under Articles 62 to 82 and Annex XV. Many lower-risk devices are evaluated without a new investigation; the evaluation always exists. For IVDs the counterpart is the performance evaluation under the IVDR.