IVD Digital & Point-of-Care Software
Digital elements are increasingly integrated into in vitro diagnostic (IVD) systems — from software that interprets instrument results to point-of-care (POC) apps that display and transmit diagnostic output. COFEPRIS regulates these elements as part of the overall IVD system.
When IVD software is regulated​
IVD software is regulated as a medical device when it:
- Interprets or calculates diagnostic results (e.g., reflex testing algorithms, result interpretation software).
- Controls an IVD instrument — the software is part of the instrument system.
- Provides a diagnostic output for clinical decision-making.
IVD software that only displays or stores results without interpretation may not be regulated as a device, but this line is context-dependent.
Point-of-care software​
POC testing software and companion apps that display results from a POC device are generally treated as part of the POC device system:
- If the POC device itself requires registration, its companion software/app is typically registered as part of the same system.
- Software updates to a registered POC device may require a modification notification to COFEPRIS.
Laboratory information systems (LIS)​
General Laboratory Information Systems used for administrative management of laboratory samples and results — without performing result interpretation — are generally not regulated as medical devices in Mexico.
However, LIS modules that include clinical decision support or result interpretation functions may cross the threshold into device territory.
Registration of IVD systems with software components​
For IVD systems incorporating software:
- The software version must be specified in the sanitary registration dossier.
- Changes to software versions post-approval must be assessed for their impact on safety and performance; significant changes require a COFEPRIS modification application.
- The Technovigilance Report at renewal must note software versions and any software-related incidents.