MDR - Engine API

General Status and Classification

Engine API is an advanced, critical technological component from Infermedica that serves as a key element of our products and is also available as a component for sale. It is possible to independently build your own application using Infermedica's Engine API. This powerful algorithmic engine leverages artificial intelligence to analyze and process medical data, and applications built on it can support clinical and operational decisions. The Engine API itself does not qualify as a medical device and is not intended for direct clinical use. Depending on the intended use of the specific application based on the API, it is the final manufacturer - the Infermedica client - who assesses its classification as a medical device or otherwise.

Facilitation

Currently at Infermedica, we are working on certifying our own products based on the Engine API and aligning the full documentation of the Engine API with MDR 2017 / 745 requirements to offer in future a full API documentation package as a critical software component certified for compliance with MDR.

Availability Territories

The product is globally available and is subject to specific regulatory restrictions as a component only, not a standalone medical device. The final classification of the end product based on the API, whether it qualifies as a medical device or not, depends on local regulatory requirements and is the responsibility of the producer of the final application.

Transition Period from MDD to MDR and Significant Change Management

We are aware that some clients have certified their applications based on the Engine API for compliance with MDR or are in the process of doing so. We assess each change to our API and medical content against the MDCG 2020-3 Rev.1 document (opens in a new tab) requirements, to ensure that any modifications do not constitute significant changes that would impact the certification under MDR.

We ensure that there are no changes to the intended purpose of the API or medical content. Any modification that might alter the product's use or extend its intended use is rigorously evaluated and avoided if it risks altering the certified status. Additionally, any changes to the design or performance characteristics that could affect safety or performance are thoroughly assessed, ensuring no impact on the certified version's performance or safety.