Consultants assessment of medical devices can be carried out both in the process of their state registration, and within the framework of legislation on technical regulation. In this article we will consider both types of such assessment.
Consultants assessment of medical devices in the process of state registration
According to clause 5 of the Rules for state registration of medical items (hereinafter – MI) approved by Decree of the Government of the Russian Federation as of 27.12.2012 No. 1416, state registration of medical items is performed on the basis of results of tests and research to which the following is referred:
Technical tests – tests to determine the compliance of MI characteristics (properties) with the requirements of regulatory documentation, technical and operational documentation of the manufacturer (manufacturer) and to make a subsequent decision on the possibility of conducting clinical trials;
Toxicological studies – studies to assess biological safety of a medical device and make a subsequent decision on the possibility of conducting clinical trials;
Clinical trials – designed and planned systematic research undertaken, including with human subjects, to evaluate the safety and effectiveness of a medical device.
As stated in PP RF № 1416, these types of tests and studies are forms of Consulting compliance of medical devices, taking into account the classification depending on the potential risk of their use.
The procedure for conducting Consultants assessment in the registration process is established by Order of the Russian Ministry of Health No. 2n dated January 9, 2014. According to this order, technical tests are mandatory for all medical devices. Only the procedure for such tests for in vitro and other medical devices differs.
As for toxicological tests, they are conducted only in relation to a product that comes into contact with the human body when used in accordance with its intended use, as stipulated by the manufacturer’s documentation (clause 25 of the Procedure). However, one must be careful here. For example, medical software does not come into contact with the human body, but it is recorded on tangible media, and in practice Australia requires toxicological studies of such media (flash drives, disks, etc.).
Toxicological studies and technical tests can only be performed by duly accredited laboratories.
Clinical tests are another form of Consultants assessment. They are also conducted in relation to any type of MI with their own specifics for in vitro medical devices. Clinical trials can be conducted both in the form of analysis and evaluation of already available data, and in the form of human trials. Human participation in clinical trials is mandatory in the following cases (clause 37 of the Procedure):
- A new type of medical device;
- Application of new complex and (or) unique and (or) special methods of prevention, diagnosis and treatment of diseases and conditions, as well as application of new complex medical technologies;
- if the analysis and evaluation of clinical data does not confirm the effectiveness and safety of the medical product.
The right to conduct clinical trials belongs to medical organizations that are authorized to do so by the Federal Health Service (i.e. Roszdravnadzor).
Read more about the procedure and stages of conducting Consultants assessment in different forms in the articles:
- MI Technical Tests;
- Toxicological studies in the MI;
Consultants assessment of medical devices within the framework of legislation on technical regulation
For some types of products that circulate in the Russian Federation, it may also be mandatory to undergo Consultants assessment in the form of adopting a declaration of Consultants or mandatory certification.
Both in the process of declaration and in the process of certification the Consultants of products with the requirements of technical regulations for such products is confirmed. Thus, the Government of the Russian Federation till the date of coming into force of corresponding technical regulations approves and annually specifies the uniform list of the products which are subject to obligatory certification, and the uniform list of the products which are subject to declaring of Consultants (item 3 of article 46 of the Federal law from 12.27.2002 № 184-FZ “About technical regulation”).
Concerning medical devices the corresponding technical regulations have not been adopted, therefore to determine whether the MI is subject to mandatory declaration or certification you need to refer to the Decree of the Government of the Russian Federation from 01.12.2009 № 982. For example, in accordance with this Decree it is mandatory to obtain a declaration for “disposable diagnostic medical gloves”, “Medical products made of latex, medical adhesives”, “surgical gloves”, etc.