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Rapid antigen tests for the diagnosis of COVID-19 cannot be sold in Romanian pharmacies, because they are tests for professional use, and “as long as the rapid tests are not used by professionals, as the manufacturer mentions in the instructions for use, the results may be compromised “, announces the National Agency for Medicines and Health Products. Instead, rapid tests can still be marketed online because there are no legal provisions prohibiting this practice, but the Medicines Agency recommends that they be sold online only if they are “for professional use only.”
“The antigen test is the newest type of test and is currently the only rapid test that detects the COVID-19 virus. This test detects antigens, that is, the part of the virus that our immune system recognizes. The antigen test can indicate an infection in “The acute phase of the disease also applies to asymptomatic people if the infection is active. The test is for professional use, which means that it is recommended that sampling and interpretation of the results be carried out by qualified medical personnel, “said the Agency. National Agency for Medicines and Health Products.
Likewise, the National Medicines Agency specifies that art. 15 of Government Decision No. 798/2003 on the establishment of the conditions of commercialization and use of medical devices for in vitro diagnosis regulates that in the case of these tests, for the application of the CE marking, the manufacturer must follow the procedure mentioned in Annex no. 3 and issue the CE declaration of conformity before placing the devices on the market. The products are marketed on the basis of the declaration of conformity provided by the manufacturer.
The National Medicines Agency points out that in the media there have been recommendations for individual use of these tests, carried out by non-professionals, and these tests are not self-tests. “Rapid self-diagnostic tests have a different marketing regime, involving a notified body that assesses the conformity of these products.”
What does the law foresee in the case of rapid tests for self-assessment?
- According to art. 16, in the case of all self-testing devices, except those included in annex no. 2 and performance evaluation devices, before issuing the declaration of conformity referred to in art. 15, the manufacturer must comply with the additional requirements established in Annex no. 3 point 6. Instead of this procedure, the manufacturer may apply the procedure provided for in art. 17 or 18.
- In Annex 3 of Government Decision 798/2003, point 6 it is mentioned: For self-assessment devices, the manufacturer must submit a request for examination of the project to a notified body, chosen in accordance with art. 23 of the decision.
- Annex 1 of Government Decision 798/2003, point 7. Requirements for self-diagnostic devices
- Self-testing devices should be designed and manufactured in accordance with the conditions to achieve their intended purpose, taking into account the skill and means available to those who use them, as well as the resulting influence of rationally anticipated variations in the abilities of the test takers. users; environmental conditions. The instructions and information provided by the manufacturer should be easy to understand and apply by the user.
- 7.1. Self-testing devices must be designed and constructed in such a way that:
- a) ensure easy use of the device by the user in all stages of the procedure;
- b) minimize the risk of errors in the handling and interpretation of the results.
- 7.2. Self-testing devices should provide, where possible, user control, such as the procedure by which the user verifies during use that the product will achieve its intended purpose.
- 8. Information provided by the manufacturer
- 8.1. Each device must be accompanied by the information necessary to identify the manufacturer and to be used safely, taking into account the training and knowledge of potential users.
- This information should appear on the label and in the instructions for use.
- 8.4. The label must bear the following indications:
- ………………………..
- k) If the device is intended for self-testing, this fact must be clearly stated.
- 8.7. The instructions for use must contain the following:
- t) Specifications for self-test devices:
- – the results must be expressed and presented in such a way that they can be easily understood by a non-professional; the information should be provided together with the user’s guidance on what to do (in the event of a positive, negative or inconclusive result) and on the possibility of false positive or false negative results;
- – certain functions can be omitted as long as other information provided by the manufacturer is sufficient to allow the user to use the device and understand the results provided by the device;
- – the information provided must include a statement that requires the user not to make any relevant medical decisions before consulting their doctor;
- – the information should also indicate that, if the self-diagnostic device is used to monitor an existing condition, the patient only needs to adapt his treatment if he has been properly prepared for it;
- u) the date of publication or last revision of the instructions for use.
- In conclusion, Annex 1 of Government Decision 798/2003, ESSENTIAL REQUIREMENTS, point A. The general requirements establish very clearly:
- The devices must be designed and manufactured in such a way that, under the conditions and for the intended purpose, they do not directly or indirectly compromise the clinical condition or safety of patients, the safety and health of those who use them or, where appropriate, of other people or property security.
- As long as rapid tests are not used by professionals, as stated in the manufacturer’s instructions for use, the results may be compromised.
- The distribution of in vitro diagnostic medical devices for professional use can be done to:
- – Other economic operators in the distribution chain, who have an operating permit for the distribution of medical devices, in order to resell or donate the products;
- – End users (health establishments, offices, clinics, etc., that carry out testing activity)
- According to art. 2 of Pharmacy Law no. 266/2008, only medical devices for individual use can be distributed through community pharmacies. As a result, in vitro diagnostic medical devices for professional use cannot be distributed through pharmacies.
- Regarding the online marketing of medical devices intended to be used by professionals, at this time there are no legal provisions that prohibit this practice.
- As a competent authority, since there are no regulations in this regard, we cannot prohibit the marketing of these products online. We may recommend avoiding this method of marketing or, if using this form of distribution, we recommend that the sale of the rapid tests be accompanied by a warning in accordance with the instructions for use, ie “FOR PROFESSIONAL USE ONLY”, or that the economic operator to ensure that the person purchasing the products is a medical unit. Otherwise, the economic operator may be penalized for deceptive commercial practices.
- All this information and recommendations are also valid for the commercialization and use of the tests used to evaluate the immune status of patients with suspected coronavirus, through the qualitative determination of the presence of IgM / IgG antibodies against SARS-CoV-2.
