The development of the IVD market (in vitro tests for self-monitoring) is of increasing importance, among other reasons due to the constantly growing public interest in their own health. More and more people are choosing to self-monitor their health at home, and for this they need suitable diagnostic tests. There are many manufacturers on the market who introduce such tests to the market every year.
However, in order to be able to do this, it is necessary to have appropriate documentation, efficacy tests and certificates, which confirm the safety of the test’s use, ease of use, reliability of the results obtained, as well as the fact that the result obtained will be the same as if the same test was carried out by a professional (e.g. diagnostician, doctor, nurse).
Self-monitoring tests do not differ from professional tests in terms of technology or reliability.
All tests (both IVD and professional) are usually based on immunochromatographic techniques), where highly specific reactions between antigens and antibodies are detected. Each IVD test must be marketed according to the guidelines of the Medical Devices Act, which contains all the information concerning confirmation of test performance, correct labelling, certification and the actual marketing in the EU.
LABELLING OF IVD TESTS
Among the many requirements that must be met in order to legally market IVD products is the need to have the so-called CE Certificate of Conformity, as well as the 4-digit number of the notified body that audits the device’s suitability for use by a person without a medical licence. Furthermore, the abbreviation IVD-In vitro Diagnostics should be placed on the packaging, as well as an additional statement: medical device for self-testing.
The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (the President of URPL) is the competent governmental authority in all matters related to the marketing and use of devices for self-testing. At Skin Lab International, we conduct specially designed tests for in vitro diagnostic devices as the first step towards their registration. We carry out tests with non-professional users to check that they are able to perform the test in accordance with the instructions for use supplied with the device. The purpose of the test is to check and confirm that the information provided to the test persons together with the product is understandable, and that the way of performing the self-test is easy and safe for them. It is also very important to know whether the result obtained by the testees will be the same as if the test had been carried out by a professional.