Classification of hospital cleaning trolleys as medical devices in the Russian Federation
When classifying devices as medical in the Russian Federation, the Federal Service for Overseeing Healthcare (hereinafter Roszdravnadzor) is guided primarily by the definition of medical devices as specified in Clause 1 of Article 38 of Federal Law No. 323-FZ dated 21 November 2011 “On the Fundamentals of Health Protection of Citizens in the Russian Federation” (hereinafter Federal Law No. 323-FZ) and in Clause 2 of Decree No. 1416 of the Government of the Russian Federation dated 27 December 2012 “On the Approval of the Rules for the State Registration of Medical Devices” (hereinafter Decree No. 1416):
“Subject to state registration are any instruments, apparatuses, devices, equipment, materials and other items used for medical purposes individually or in combination, and also together with other accessories necessary for the operation of these items as per indications; this includes specific software products and medical devices intended by the producer (manufacturer) for the prevention, diagnostics, treatment and medical rehabilitation of diseases, for the monitoring of human body parameters, for medical investigations, recovery, substitution, change of the anatomical structures or physiological functions of the body, for the prevention or termination of pregnancy, and their functionality is not performed by means of the pharmacological, immunological, genetic or metabolic effect on the human body”.
From this definition, it is difficult to understand whether hospital cleaning trolleys are medical devices.
Clause 5 of Article 38 of Federal Law No. 323-FZ and Clause 2 of Decree No. 1416 contain conditions under which state registration of a medical device is not required, but hospital cleaning trolleys do not fall under these conditions.
In addition, Roszdravnadzor uses Recommendations of the Board of the Eurasian Economic Commission No. 25 dated 12 November 2018 “On the Criteria for Attributing Products as Medical Devices within the Eurasian Economic Union” (hereinafter Recommendations No. 25) for classification.
According to the latest comments received from Roszdravnadzor regarding the state registration of hospital cleaning trolleys, they are not medical devices for the following reasons (excerpts from Roszdravnadzor’s comments are listed below):
“… are not attributed as medical devices due to the lack of medical purpose, …, namely: “to move containers with liquids inside healthcare facilities, to carry buckets with mops, brushes, cleaning substances, dustpans, dispensers, garbage bags and other equipment”…”
“… in accordance with Clause 32 of Recommendations of the Board of the Eurasian Economic Commission No. 25 dated 12 November 2018 “On the Criteria for Attributing Products as Medical Devices within the Eurasian Economic Union”, if a piece of furniture is not used in a special medical location (medical treatment room, operating theatre, etc.) and is not used for medical purposes in accordance with its intended use, such products cannot be attributed as medical devices…”
Clause 32 of Recommendation No. 25 is worded as follows:
“32. If a piece of furniture is not used in a special medical location (medical treatment room, operating theatre, etc.) and is not used for medical purposes in accordance with its intended use, such products cannot be attributed as medical devices. Examples of non-medical products:
a) a desk;
b) office chairs;
c) sofa, chairs, banquettes and other furniture used in a waiting room for patients;
d) a cabinet for storing medical products which do not require special storage conditions;
e) furniture for dining rooms in healthcare facilities.”
This Clause contains no explicit reference to trolleys, but Roszdravnadzor classifies them as “furniture”.
When asked whether the codes for the type of medical devices are available in the Register of the Russian Federation — the “Nomenclature Classification of Medical Devices by Type” — the code for hospital cleaning trolleys, an indirect method for determining “whether the product is attributed as medical devices”, Roszdravnadzor replied as follows:
“…according to the information of the Federal State Budgetary Institution “National Institute”, which is responsible for maintaining the Nomenclature Classifier of Medical Devices, the type code 153900 “Medical Trolleys. Cleaning trolleys (a trolley used by personnel performing sanitary and hygienic cleaning of the premises of a healthcare facility to carry buckets with mops, brushes, cleaning substances, dustpans, dispensers, garbage bags and other equipment)” was excluded from the nomenclature classifier in 2017, but information about it was not excluded from the electronic service of Roszdravnadzor, the “Nomenclature Classification of Medical Devices by Type” by the persons responsible for this procedure…”
When asked whether similar products are registered as medical devices in the “State Register of Medical Devices and Organizations (Individual Entrepreneurs) Engaged in the Production and Manufacturing of Medical Devices”, another indirect method for determining “whether the product is attributed as medical devices”, Roszdravnadzor replied as follows:
“…Order No. 206n of the Ministry of Health of Russia dated 23 March 2020 “On Approval of the Procedure for Organizing and Conducting an Expert Examination of the Quality, Efficiency and Safety of Medical Devices”, stipulating the procedure for cancelling the state registration of devices which are not medical but registered as medical, came into force on 02 August 2020…”
In this case, Roszdravnadzor implies that it will carry out work on the cancellation of registration certificates of devices which at some point have lost their status as medical devices.
The latest device, similar to the hospital cleaning trolley, was registered as medical in mid-2018. Since then hospital cleaning trolleys have probably lost their status as medical devices. However, based on the comments above, Roszdravnadzor leaves a possible loophole for the registration of specialized groups of such devices. A clear indication in the use of premises to be cleaned is required with special requirements for cleanliness — operating theatres, medical treatment rooms, etc.