Interchangeability of Medical Devices

Anna Ivanova, Associate at BRACE Law Firm ©

January 12, 2022

The issue of interchangeability for both medicinal products and medical devices remains acute under current legislation. As Timofey Nizhegorodtsev, Head of the Social Sphere and Trade Control Department of FAS Russia, previously noted: "To date, most measures dedicated to the circulation of medical devices have not yet been implemented. In particular, this concerns the key issue: establishing the procedure for determining the interchangeability of medical devices, including consumables. While we have resolved this problem on the medicinal products market together with the Ministry of Health, we still have to address this issue on the market for medical devices and consumables". [1]

As a reminder, the Roadmap for the Development of Competition in Healthcare provided for the development of a Decree of the Government of the Russian Federation establishing the procedure for determining the interchangeability of medical devices, including consumables, and administrative regulations for determining such interchangeability. [2] Currently, the official website for draft legislation indicates that since 2018, the Government has been preparing a draft Decree of the Government of the Russian Federation On the Procedure for Determining the Interchangeability of Medical Devices. However, this project has remained at the public discussion stage. Thus, there is currently no finalized text of the draft law or information on interchangeability criteria, and the general definition of interchangeability for medical devices established in current Russian legislation does not address the fundamental questions related to establishing interchangeability criteria.

According to Article 4 of Federal Law No. 135-FZ dated July 26, 2006, On the Protection of Competition (the "Law on Protection of Competition"), interchangeable goods are "goods that can be compared by their functional purpose, application, qualitative and technical characteristics, price, and other parameters in such a way that the purchaser actually replaces or is ready to replace one product with another during consumption (including consumption for production purposes)". As FAS Russia explains, identifying goods that are potentially interchangeable with a given product is carried out through:

• expert assessments;
• analysis of goods comparable in essential properties that belong to the same classification group of one of the All-Russian classifiers of types of economic activity, products, or services. [3]

Article 38 of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law No. 323-FZ") introduced a requirement to enter information on interchangeable medical devices into the state register of medical devices. Medical devices may be recognized as interchangeable if they are comparable in functional purpose, qualitative and technical characteristics, and are capable of replacing each other. According to Clause 3 of the Safety and Effectiveness Requirements for Medical Devices, approved by the Council of the Eurasian Economic Commission, the restriction of interchangeability of medical devices through the use of special technical or software means or other methods is prohibited. [4]

However, this definition is neither complete nor comprehensive enough to resolve existing legislative gaps regarding the establishment of interchangeability for medical devices.

It is important to note that interchangeability issues for medical devices are sometimes more acute than for medicinal products. This is primarily due to the vast number of medical devices in circulation, the complexity of assessing their qualitative characteristics, and the lack of interest among medical device manufacturers themselves in establishing interchangeability. Furthermore, as mentioned above, the Rules for Determining the Interchangeability of Medicinal Products for Medical Use were established for medicinal products and approved by Government Decree No. 1360 dated September 5, 2020. Under these rules, medicinal products must also undergo expertise at the FSBI Scientific Center for Expertise of Medical Products. A similar legal act for establishing the interchangeability of medical devices does not currently exist.

Under European Union Regulation 2017/745 on medical devices (MDR), the collection of clinical data already present in scientific publications and/or clinical trial results is permitted. The concept of equivalence with other medical devices for which clinical data is already available is applicable. The regulation itself effectively defines interchangeability for the classification of safety and performance characteristics of medical devices. [5] Additionally, the FDA uses the concept of "substantial equivalence", which refers to identity in safety and effectiveness. A medical product possesses substantial equivalence if it has the same intended use as a predicate product and uses the same technologies; or it uses different technologies, provided they are well known to the FDA and do not create new risks compared to the predicate product. [6]

In Russian legislation, the concept of interchangeability of medical devices applies in two aspects:

• Providing medical care to patients / equipping medical institutions;
• Conducting state and municipal procurement.

In the first case, interchangeability is vital for patient safety, the ability to choose the optimal medical device given the availability of analogues, and the safety of the medical device itself. As a general rule, when conducting expertise on the safety, quality, and effectiveness of medical devices, a risk-oriented approach applies: expert requirements for the scope and degree of detail of evidentiary materials (documents) in the registration dossier are proportional to the potential risk class of the medical device's use. During the analysis of a medical device, experts assess characteristics contained in the instructions for use and other materials available to the end-user, as well as characteristics used by the manufacturer to prove the medical device's compliance. [7]

Despite undergoing safety checks, clear criteria for patients to choose analogues are lacking. In practice, when choosing a medical device, patients rely on instruction data, advertising materials, and specialist consultations.

In the second case, regarding procurement, numerous disputes arise concerning the interchangeability of medical devices, which are resolved based on an individual assessment of their characteristics. This occurs because, according to Part 1 of Article 33 of Federal Law No. 05.04.2013 No. 44-FZ On the Contract System in the Sphere of Procurement of Goods, Works, and Services for Ensuring State and Municipal Needs (the "Contract System Law"), the description of the procurement object must be objective. The description of the procurement object must not include requirements or references to trademarks, service marks, brand names, patents, utility models, industrial designs, the name of the place of origin of the goods, or the name of the manufacturer, nor requirements for goods, information, works, or services, provided that such requirements lead to a restriction on the number of bidders, "except for cases where there is no other way to provide a more accurate and clear description of the characteristics of the procurement object".

Consequently, the absence of interchangeability criteria leads to many disputes.

For instance, FAS Russia believes that vacuum blood collection systems registered in the Russian Federation that have a common purpose are interchangeable and form a single commodity market. Thus, the control authority decided that when procuring vacuum blood collection systems, it is impermissible to establish requirements for the size of the tube cap, the presence or absence of a threaded connection between the tube and cap, or double color-coding of the tube cap. [8]

However, when considering individual disputes, control authorities sometimes maintain opposite positions. For example, the Krasnodar UFA concluded that in the register entry for the medical device "Reagents for hematological analyzers KX-21N, SF-3000, XS-800i/1000i, XT-1800i/2000i, XT-4000i, XE-2100", registration certificate FSZ 2010/07179, information on interchangeability is absent. Consequently, the complaint of a potential bidder who intended to supply what they considered an interchangeable medical device was recognized as unfounded. [9]

A contrary position was taken in another case where the applicant cited the lack of information on functional characteristics in the medical device documents, including the needle chamber size, and challenged the requirement for a chamber volume of 4 μl of blood as unjustified. The control authority concluded that when a Customer establishes requirements for bidders' descriptions of goods in the documentation or procurement notice, it must consider that the Contract System Law does not require a bidder to possess the goods at the time of bid submission. Therefore, the Customer's requirements to describe the chemical composition, components, or production technology indicators in detail (via indicators and/or their values, whether as a single value, a range, or a fixed value), or indicators known only upon testing a specific batch after production, show signs of restricting access to the procurement. Consequently, regarding the "chamber volume of 4 μl of blood" position, the Customer failed to provide documentary evidence that a bidder who does not possess the goods at the time of submission could determine this value. Therefore, the complaint was recognized as justified. [10]

Thus, despite the mandatory requirement to enter information on interchangeable medical devices into the state register, the establishment of various requirements for medical devices by state and/or municipal Customers is subject to individual evaluation by the control authority.

Furthermore, one must note the introduction of the nomenclature of medical devices and restrictions on combining certain medical devices into a single lot. According to Decree of the Government of the Russian Federation No. 620 dated April 19, 2021, On the Requirement for the Formation of Lots during the Procurement of Medical Devices that are the Object of Procurement for State and Municipal Needs, medical devices of different types according to the Nomenclature Classification of Medical Devices by Type (approved by the Ministry of Health of Russia) cannot be the subject of a single contract (one lot), provided that the value of the Initial Maximum Contract Price (IMCP) exceeds:

• 600,000 rubles — for Customers whose volume of funds directed toward medical device procurement in the preceding year was less than 50 million rubles;
• 1 million rubles — for Customers whose volume of funds directed toward medical device procurement in the preceding year was between 50 million and 100 million rubles;
• 5 million rubles — for Customers whose volume of funds directed toward medical device procurement in the preceding year was more than 100 million rubles.

Therefore, when determining the applicability of the Decree, one must proceed from the planned IMCP.

Ministry of Health Order No. 4n dated June 6, 2012, approved the nomenclature classification of medical devices, under which the Classification of Medical Devices is formed electronically by groups and subgroups and published on the official Roszdravnadzor website.

However, the requirements to exclude different types of medical devices from a single lot do not apply to procurements where medical devices are combined in one lot (contract) with consumables provided by the manufacturer (producer) for the use of those medical devices.

For example, in its decision dated January 18, 2018, in case No. 09oz-18, the Arkhangelsk UFA accepted the arguments of a Customer procuring consumables from a specific medical device manufacturer as justified, since "the manufacturer guarantees the correct operation of the STERRAD 100S sterilizer only when using consumables that have been tested in the system. According to the instructions for the use of consumables for the STERRAD sterilization system". [11]

Additionally, the Tatarstan UFA decided that the possibility of operating medical equipment from one manufacturer together with accessories from another manufacturer is determined exclusively by the equipment manufacturer. Since the state register of medical devices and organizations (individual entrepreneurs) manufacturing and fabricating medical devices contains no information on the interchangeability of consumables for the Biosen C Line analyzer (EKF-diagnostic, Germany), the supply of consumables from a different manufacturer is not justified. [12]

On one hand, introducing the nomenclature is an important step toward organizing information on medical devices. The 2021 establishment of restrictions on combining lots also serves as a preventive measure against Customers abusing their rights to establish specific requirements for the procurement object.

However, it must be noted that because of the very large number of medical devices in circulation, the nomenclature is incomplete. Furthermore, the procedure for correcting the nomenclature has not yet been established. We believe that legal acts regulating who is entitled to initiate changes to the nomenclature or assess a medical device's compliance with the nomenclature will be adopted in the future.

Additionally, Decree of the Government of the Russian Federation No. 2026 dated November 24, 2021, On Unregistered Medical Devices for In Vitro Diagnostics, enters into force on March 1, 2022. According to this decree, such a device is one intended for diagnosing diseases by studying human biological material samples outside the body, manufactured in a medical organization, and used in the medical organization that manufactured it. For an unregistered in vitro diagnostic medical device in the Russian Federation, there must be no interchangeable medical device registered in the established order in circulation. As seen from this legal act, information on the interchangeability of medical devices must also generally be obtained from the state register of medical devices. Legal acts establishing additional interchangeability criteria and the procedure for assessing the interchangeability of medical devices do not currently exist.

In view of the above, it is worth noting that in the absence of established legislative regulation of this issue, the explanatory practice of FAS Russia and the law enforcement practice of its regional offices play a special role. Additionally, a legal risk assessment for the formation of lots and procurement object requirements (for Customers) and the formation of bids/proposals (for potential suppliers) is vital for both organizing procurement and participating in it.

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References

[1] FAS Urged the Ministry of Health to Resolve the Issue of Interchangeability of Medical Devices. TASS dated June 11, 2021.

[2] Order of the Government of the Russian Federation No. 9-r dated January 12, 2018, On Approving the Action Plan (Roadmap) for the Development of Competition in Healthcare.

[3] Order of FAS Russia No. 220 dated April 28, 2010, On Approving the Procedure for Conducting Analysis of the State of Competition on the Commodity Market.

[4] Decision of the Council of the Eurasian Economic Commission No. 27 dated February 12, 2016, On Approving General Requirements for the Safety and Effectiveness of Medical Devices, Requirements for Their Labeling and Operational Documentation.

[5] New Regulation on Medical Devices (2017/745/EU) (MDR) // European Commission. Factsheet for Manufacturers of Medical Devices.

[6] What is 510(k) for Medical Devices – Abbreviated, Traditional, and Special Regulatory Procedure Options. November 2021.

[7] Recommendation of the EEC Board On Methodological Recommendations for Conducting Expertise on the Safety, Quality, and Effectiveness of Medical Devices for the Purpose of Their Registration within the Eurasian Economic Union dated May 21, 2019, No. 14.

[8] Letter of FAS Russia No. IA/29987/15 dated June 17, 2015, On Sending Clarifications of FAS Russia on the Consideration of Complaints and Appeals Regarding the Procurement of Vacuum Blood Collection Systems.

[9] Decision of the Krasnoyarsk UFA of Russia No. 1370 dated December 6, 2018.

[10] Decision of the Vladimir UFA of Russia dated June 1, 2021, in Case No. 033/06/33-496/2021.

[11] Decision of the Arkhangelsk UFA dated January 18, 2018, in Case No. 09oz-18.

[12] Decision of the Tatarstan UFA of Russia No. 04-04/18445 dated December 12, 2019.