When do you have to obtain a separate medical certification for your solution?

A quick primer on medical device regulations

All modules provided by Infermedica (except API) are certified medical devices within the European Union (CE). They are designed and developed in accordance with the Quality Management System (QMS) Certification, based on the ISO 13485:2016 standard. Infermedica’s quality assurance ensures that all products undergo rigorous testing before being released to ensure the highest quality.

Triage may need to be certified directly by the customer if changes are made beyond the listed and agreed capabilities (please read this article about red-flagged words -> ).

The Infermedica API is a set of tools that enable you to build custom solutions (medical apps, symptom checkers, bots). As the final shape of these solutions is determined during the implementation, it is impossible to certify them in advance.

Hence the company implementing the solution is responsible for assessing whether their application is a medical device, as defined by Medical Device Regulation (EU) 2017/745. In this case, Infermedica may act as a supplier of key components, but it is not the final manufacturer and, therefore cannot be held responsible for the certification of the product.

For detailed information, don't hesitate to contact your dedicated Customer Success Manager and the legal team within your organization.


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