Document paper New medtech regulations

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.

Posted on 20.04.2016

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