Introduction

The shelf life of a medical device determines the period during which the product retains its functional properties and technical specifications established by the manufacturer. After the state registration of a medical device in the territory of the Russian Federation, the established value of the shelf life can be changed in accordance with the Decree of the Government of the Russian Federation from December 27, 2012 No. 1416, paragraph 39.

1. Necessary changes in the manufacturer’s documentation

To make amendments to registration documents in terms of increasing the shelf life of a medical device, the manufacturer or his authorized representative have to submit the following documents to the Federal Service for Supervision of Health Care:

• A letter about amendment indicating the number of the Registration Certificate and the list of products or composition elements for which the shelf life is increased
• Technical File
• Operating Instructions or Instructions for Use
• The Power of attorney from the manufacturer to the Authorized representative, if the documents for making amendments are provided by the Authorized representative.
• Original Registration Certificate
• Information on the payment of the government fee for amendments to documents requiring an expertise of the quality, effectiveness and safety of a medical device
• Test results from the accredited laboratories in the Russian Federation to confirm the increased shelf life of a medical device

Table 1 lists the parts that should be updated in the Technical file for sterile and non-sterile devices with an increase in shelf life.

Table 1 – parts of a Technical file necessary to be updated with increasing shelf life of a medical device

Type of medical device regarding sterility	Parts of the Technical file to update information
Non0sterile device	– Shelf Life information – Layout or photo of the packaging label indicating the new shelf life – Risk management file
Sterile device	– Shelf Life information – Layout or photo of the packaging label indicating the new shelf life – Risk management file – Validation of the packaging process – Shelf life validation

In the instructions for use, the information about shelf life is updated.

Additional comments must be added to the above reports: in the risk management file according to GOST ISO 14971-2011, information about the change in the shelf life should be taken into account.

The validation of the packaging process in accordance with GOST ISO 11607-1-2018 and GOST ISO 11607-2-2018 in the technical document must be updated if it includes the test results of the integrity and sterility of the product packaging after the expiration date. The test results of the product packaging after the expiration date can be given in the shelf life validation section, in this case the packaging validation section is not required to be updated.

The shelf life validation section should include the test results of medical device samples under aging conditions in accelerated and real time, justifications of the selected accelerated aging modes should also be given. The section should contain the following  information about the samples that have passed the test: the serial number, catalog number and production date.

The expiration validation report should confirm that the declared technical characteristics of the device have not changed after the device reaches the maximum shelf life. And the product remained sterile. It is also necessary to provide information on maintaining the integrity and sterility of individual packaging in the absence of such information in the packaging validation section.

2. Test types and requirements for the samples to confirm increased shelf life

Amendments in the technical and operational documentation under paragraph 39 of Decree No. 1416 go through an expertise of the quality, effectiveness and safety of a medical device in an expert center of The Roszdravnadzor. To confirm the increased shelf life of the device, the following types of tests exist:

• The tests conducted by the manufacturer, with the creation of the reports mentioned in the previous section.
• Tests in accredited laboratories in the Russian Federation to confirm amendments made to registration documents.

Tests in accredited laboratories include biocompatibility testing and technical testing to confirm the biological safety of the product, sterility and compliance with the technical specifications stated in the manufacturer’s documentation.

Samples for biocompatibility testing are selected in accordance with GOST 31214-2016. For technical testing, it is necessary to take into account various product designs, minimum and maximum overall characteristics, and also the requirements of standards for a particular device. The main requirement for samples is the expiration date mast be expired. At the same time, if the manufacturer of the medical device compiled the detailed report on validation of the shelf life, the requirements for which are specified in section 1, then samples for technical testing can be provided with an effective expiration date. In this case, the technical laboratory will refer to the test results of the manufacturer.

In case that the manufacturer does not have a sufficient number of expired samples, it is possible to consider the artificial aging of samples with an effective shelf life. Such tests can be carried out by the manufacturer or in an accredited laboratory in the territory of the Russian Federation. It’s important to include in the test report information about the samples and information about the conditions of accelerated aging.

When preparing a set of documents for submission to Roszdravnadzor, it is necessary to indicate the reason for the amendments in accordance with paragraph 39 of decree No. 1416. This are changes in the technical and operational documentation of the manufacturer, as well as changes  in the labeling, since the labeling contains information about the date of manufacture and the shelf life of the product.

Conclusion

The information in the article allows you to evaluate the features of the preparation of documentation for the manufacturer of a medical device. Also, it helps to take into account the requirements for manufacturer’s reports, depending on the type of product in terms of sterility, and take into account the requirements for the selection of samples for testing in order to amend registration documents and increase the shelf life of the medical device.