Medical Device Regulation compliance

Introduction

Regulation (EU) 2017/745 on medical devices (MDR) introduces a major update of the regulatory framework in the European Union (EU). No new certifications under the current Directive can take place after 26 May 2021. Significant changes, such as device design or intended use changes, must not be implemented under MDD certification after the MDR Date of Application (26th of May 2021).

API-based solutions

All solutions based on Infermedica API have a broad spectrum of possible implementation and usages. Solutions based on Infermedica API are certified separately as a final software medical device. The API product itself is not a medical device. The ready-certified API-based medical device manufacturer is responsible for the management of significant changes in the device.

Infermedica is aware that the interpretation of the significant changes in API can be different depending on the specific Notified Body view or even the individual auditor opinion. That is why we have prepared the supporting process for API clients who would like to stay with the certified API version for a period longer than Infermedica’s new API release cycle.

We assure you that:

  • The last available API version (3.3) was frozen on 25th of May, 2021 and will be maintained without any changes. The maintenance will only cover bug fixing and technical issues.
  • The last version of the medical content database was frozen on 25th of May, 2021. The maintenance will only cover technical issues and language hotfixes without adding new symptoms and conditions, translations, or even bug fixes.

Medical content creation is a constant improvement process supervised by a team of over 30 Medical Doctors and further protected by various automatic alerts and validation algorithms. As its development is ongoing (although updates are released about once every 1-2 months), it is impossible to maintain a “frozen” version of the content while still receiving updates or hotfixes. Such changes to outdated content would create an alternate version of the content that would not be supervised by our medical team or automatic checks, which would enable any medical mistake or model instability to go unnoticed.

Our capacity for interview analysis, content improvement, or feedback review will be minimal for the frozen model.

The only change that will always be available for a frozen version of content is language hotfixes.

Support

Have questions? Contact us at: support@infermedica.com