How to demonstrate clinical equivalence for MDSW when competitor data is unavailable?

Question

We are developing a medical device software (MDSW) that appears equivalent to others already on the market. However, we do not have access to detailed technical descriptions or clinical data of these competitor devices, only published papers with results.
We have been advised to buy the competitor’s software and compare it to ours, but we find this approach questionable. Is it mandatory to acquire and compare the actual competitor device, or can published literature suffice?
Are there alternative strategies to demonstrate equivalence, and if not, how complicated is it to conduct a clinical investigation for a class IIa MDSW?

Dr. Oliver Eidel · Accepted Answer

In clinical evaluation based on equivalence, a key issue is legal access to clinical data from the equivalent device. Regulations, such as MDR, often restrict use of equivalence to devices from the same manufacturer or within the same organisation, making it hard to apply to competitor devices.
For standalone software, it's important to review MDCG 2020-1 to determine if clinical data is required, or if your evaluation can be based on the other pillars (like scientific literature and performance data).
Referring to published data from similar or potentially equivalent devices is generally feasible, but you must demonstrate sufficient access to the data according to MDR Annex XVI. In practice, this is challenging between different manufacturers.
Conducting a clinical investigation is not always mandatory for class IIa devices—it depends on classification, intended use, and available data. There is no fixed rule, so review the guidance and consider consulting your Notified Body for specific advice.

Answer

I'm not an expert, but buying a competitor's product for equivalence isn't so unusual. When a device is offered on the market, aspects of it are considered public. The idea is to compare how it works, not to reverse engineer or copy any intellectual property. For example, with a thermometer, you would buy and compare the measurements, which seems reasonable.
However, I can't speak to whether this is required, and the regulations are not always clear. You might want to check with your Notified Body for their expectations.

How to demonstrate clinical equivalence for MDSW when competitor data is unavailable?

2 Answers

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