The Ministry of Health of the Russian Federation approved the procedure for the use of unregistered medical devices for in vitro diagnostics

The Ministry of Health of the Russian Federation approved the procedure for the manufacture, storage and disposal of unregistered medical devices for in vitro diagnostics. The clinic will have to produce medical devices in accordance with technical regulations, the product itself will have to be labeled, and the accompanying documentation for it will have to be stored for 15 years after the expiration date or the last use.
The procedure was approved by order of the Ministry of Health of the Russian Federation No. 1031n dated November 2, 2021. According to the document, the manufacture of medical devices will be carried out according to technical regulations, the product itself must be marked in the form of labels with the name, date of manufacture, expiration date, number or batch code, storage conditions and information about its sterility.

An unregistered medical device for in vitro diagnostics should be used in accordance with the operational documentation, in compliance with the rules for conducting laboratory tests, procedures for the provision of medical care and with the patient’s voluntary informed consent, including information about the additional risks associated with this.

Destruction of medical devices must be carried out within 65 days in case of expiration, violation of storage conditions or revocation of permission to manufacture unregistered medical devices for in vitro diagnostics.

In addition, for each of the medical devices in the clinic, documentation must be kept, including information about the technical, operational documentation and technical regulations, the date of manufacture of the unregistered medical device, the batch and batch, the date of control of the compliance of the product with the requirements of technical documentation and the expiration date.

The accompanying documentation should include the decision of the head of a medical organization or a person authorized by him on the manufacture of an unregistered medical device, information on materials – raw materials, reagents, components for its production, as well as information on the name, manufacturer and shelf life of raw materials. In addition, copies of clinical trial reports or microbiological findings for patients with congenital or hereditary diseases performed using an unregistered IVD medical device are required.

The documentation must be kept in a medical organization for 15 years.

Amendments to 323-FZ „On the Fundamentals of Health Protection of Citizens in the Russian Federation“, allowing for the possibility of manufacturing, storage and use of unregistered medical devices for in vitro diagnostics if the medical organization has a permit issued by Roszdravnadzor to use such a product were adopted by the State Duma and the Federation Council and signed by the President of the Russian Federation Vladimir Putin on April 30, 2021.

In August 2021, the Ministry of Health published preliminary regulations for the manufacture, storage and disposal of unregistered medical devices for in vitro diagnostics.

In November 2021, the State Duma and the Federation Council approved the amount of state fees for issuing a permit for the use of unregistered medical devices for in vitro diagnostics, which will amount to 9.5 thousand rubles, for conducting an examination of the quality, safety and effectiveness of such medical devices – 65.8 thousand rubles, repeated examination will cost 54.5 thousand rubles.