Benchmark or Similar Devices

In the Clinical Evaluation Plan (CEP), the “Benchmark or Similar Devices” chapter serves to provide a crucial frame of reference for the clinical evaluation by identifying and describing existing devices on the market that are comparable to the device under evaluation. The purpose of this chapter is to clearly delineate the landscape of products that are similar or can serve as benchmarks in terms of design, intended use, or technological characteristics within the current state of the art. This facilitates the evaluator’s understanding of the technological positioning of the device under evaluation and provides a basis for subsequent equivalence demonstrations (if applicable), the establishment of performance and safety acceptance criteria, and the benefit-risk analysis.

When composing this chapter, the core lies in selecting appropriate comparator devices and presenting their key information in a professional and concise manner, while also articulating their relevance to the device under evaluation.

Considerations for Selecting Benchmark or Similar Devices

The selection of devices as benchmarks or comparators should not be arbitrary but based on clear and justifiable criteria. Typically, priority should be given to products that demonstrate significant relevance to the device under evaluation in one or more of the following aspects:

• Intended Use and Indications: Select products whose intended use, target patient population, and clinical application scenarios are highly consistent or very similar to those of the device under evaluation.
• Technological Characteristics and Mechanism of Action: Focus on products that employ similar technological principles, key designs, or mechanisms of action.
• Materials and Construction: For devices where materials are a critical aspect, the similarity of principal materials is also an important consideration.
• Market Representation and Acceptance: Choose products that have a well-established history of use in the target market (especially the EU market), are widely accepted clinically, or represent mature technologies within the current state-of-the-art (SOTA).
• Regulatory Status: Generally, select products that have already obtained CE marking (under MDR or MDD) or are marketed in other major regulatory jurisdictions (e.g., FDA cleared/approved).
• Equivalence Demonstration Needs: If the clinical evaluation pathway involves demonstrating equivalence to a device already on the market, then that “equivalent device” will be compared with the device under evaluation in the relevant chapter.

Describing Selected Benchmark or Similar Devices

For each selected benchmark or similar device, a concise informative profile should be presented. A mere laundry list of numerous parameters is not advisable; the key is to extract and present the information most critical for understanding the device’s characteristics and its comparability to the device under evaluation. Typically, the description for each device should include the following aspects:

Begin by clearly stating the accurate name of the product, model number (if applicable), and its manufacturer. Following this, briefly outline its regulatory status in key markets, such as whether it has obtained a CE mark and the regulation it conforms to (MDR/MDD), or its FDA clearance/approval status in the United States.

The core content should focus on articulating the product’s intended use and indications for use , as this directly relates to its clinical comparability with the device under evaluation. Subsequently, the description should center on its key design and technological features. This part needs to be elaborated based on the type of device, for example: * For active devices, this might involve their operating principles, key performance parameters (e.g., energy output range, frequency). * For passive implants, the focus might be on their main structural materials, surface treatments, mechanical performance indicators. * For in-vitro diagnostic devices, attention would be on their detection principles, sample types, and main analytical performance characteristics (e.g., sensitivity, specificity).

If summary information regarding the known safety and performance profile of the product can be obtained from public sources (such as product IFUs, manufacturer websites, published literature, regulatory agency databases), and this information is substantively relevant for subsequent comparative analysis, it should also be briefly mentioned here. For instance, known clinical application outcomes, or rates of major complications.

Articulating Relevance to the Device Under Evaluation

After describing the basic situation of each benchmark or similar device, clearly articulate why that product was selected and its specific relationship to the device undergoing clinical evaluation. For example, is it a predicate for an equivalence claim (i.e., an “equivalent device”)? Does it represent the mainstream technological level of similar products currently on the market? Or is it highly comparable to the device under evaluation due to a specific design or performance characteristic? Clarifying this relationship helps the reader understand the logic and significance behind choosing these particular devices for comparison.

Organizing and Presenting Information

While a systematic comparison of the core characteristics of each benchmark or similar device is sometimes necessary within this CEP chapter, for instance, when comparing multiple products across several parameters, appropriately using internal tables to summarize these specific parameters (such as materials, performance indicators) can make the information readily understandable. After introducing each product individually, a brief summary can distill commonalities, differences observed among these benchmark or similar devices, and their implications for evaluating the device under evaluation.