There has been a lot of emphasis on how the clinical benefits of a medical device are addressed in the clinical evaluation. EU MDR defines the clinical benefit as “the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health”. The manufacturer needs to define direct or indirect clinical benefits for their device in the Clinical Evaluation Plan. For example, a diagnostic device directly benefits patients with early or accurate diagnoses of their medical condition. Similarly, an accessory medical device has indirect benefits if it facilitates a treatment procedure that alleviates symptoms. Clinical data should support direct benefits. Indirect clinical benefits may be demonstrable by evidence such as pre-clinical and bench testing data, real-world data (device registries), or clinical data from another device that is used in conjunction for achieving the intended purpose.
While defining the clinical benefits, the benefits’ nature, extent, probability, and duration should be considered according to MEDDEV 2.7/1 rev.4 Appendix A7.2 Section b. Each clinical benefit should have corresponding specific and measurable objectives. Clinical endpoints can be identified from clinical data that quantifiably demonstrate device safety and performance. For example, sensitivity, specificity, or accuracy values could be endpoints for a diagnostic device.
Acceptance Criteria from State-of-the-Art
It is now well-known that the clinical evaluation should include a comprehensive review of the current clinical knowledge and state-of-the-art relevant to the device in question. The objective is to compare the device’s benefit-risk profile in the context of other similar devices and alternatives available on the market. To satisfactorily demonstrate conformity to GSPRs, the acceptance criteria for the clinical endpoints of safety and performance must be determined from the clinical data evaluated in the state-of-the-art review from applicable standards and common specifications, clinical practice guidelines, or outcomes presented in published literature. For example, acceptance criteria for radiation safety can be derived from international standards for diagnostic radiation exposure. Similarly, the ‘treatment success rate’ reported in clinical studies can be considered acceptance criteria for a medical device’s performance.
The MDCG 2020-5 guidance on equivalence is a very comprehensive and suitable reference for clinical evaluation based on the equivalence pathway. Equivalence with a previous generation device or another device from the same family can be demonstrated per the template provided in the MDCG 2020-5 guidance. The focus should be on assessing differences in the clinical, technical, and biological characteristics in the context of device safety and performance. Suitable evidence and references should be provided to establish that the differences between the device in question and the device presumed to be equivalent are not clinically significant. Furthermore, while considering two or more devices as equivalent may be acceptable, comparing clinical, technical, and biological characteristics is expected with each device in the clinical evaluation. It is advisable to consider a single device as the equivalent device.