The CDS, as a software used for prevention of disease, is submitted to the EU 2016/45 regulation on medical devices. This is confirmed by the Manual on borderline and classification for medical devices, where it falls under the category of medical calculators.
As such, it is submitted to stringent verification rules before release to production.
The development of the CDS engine must be performed according to a strict quality management system, typically certified against the ISO 13485 standard, that implies that requirements for its safety and useability are expressed upfront and checked consistently during the whole development process.
This verification fails under the responsibility of the CDS provider, that will demonstrate it to the implementing Member State by exhibiting the required certificate.
Misuse of a CDS due to confusing user interfaces is among the risks that must be evaluated and mitigated during its design. Although these interfaces are realised within the client systems, these realisations should:
Verification of the ruleset (Task K4) is conducted by the MS immunization experts, who compare the CDS responses for clinical cases with the expected results. This comparison is facilitated by the specific tooling provided to experts, including the comparison between results of different releases of the ruleset.
Verification of codifications (Tasks M1, M2) is the responsibility of the client software editors through the following process: