Requirements for point of care testing systems – Proposal for an IVD Regulation

In their General Approach (Art. 40), the Council has proposed general safety and performance requirements for usability that are specific to self-testing and to point-of-care devices. In order to control for compliance with all the general safety and performance requirements including usability, they have proposed a full technical documentation assessment for each individual self-testing and point-of-care device.

Because self-testing and point-of-care devices have fundamental differences, it makes sense to control them differently. A technical review as determined by the class of the device should be followed for point-of-care devices, because:

1. Self-testing and point-of-care devices are different when it comes to their use, environment and level of complexity. Point-of-care testing systems are designed to be used by a health care professional who will typically have received training to use the device. Users of self-tests will normally not receive training;
2. Many point-of-care devices are platforms which run an array of tests. It does not make sense to require an individual technical file review for every individual point-of-care test which runs on the same platform. The notified body should focus on assessing the technical file for different point-of-care assays, not evaluating similar assays as if they are a different device;
3. The resources of the notified body system should be focussed according to the device risk and support continued innovation by the IVD sector in the field of point-of-care testing.

Art. 40(3) and Art. 40(4) should therefore be amended to delete a requirement for point-of-care testing devices to follow Section 6.1 of Annex VIII.

More detail on this position is explained in the annex to this paper. Download the paper to read more.