Technical and Operational Documentation for Medical Devices in Russia: Development and Legal Requirements

 

June 20, 2026

BRACE Law Firm ©

 

A comprehensive set of documents defining the structural features, operating rules, storage, and maintenance procedures must accompany every medical device. A medical device cannot be registered or released into civil circulation without technical and operational documentation.

The regulatory landscape changed in September 2025: the new Order of the Ministry of Health of Russia No. 181n dated April 11, 2025, On Approval of Requirements for the Content of Technical and Operational Documentation of the Manufacturer of a Medical Device, entered into force. It remains valid until September 1, 2031. It invalidated the previously effective Orders of the Ministry of Health of Russia No. 11n dated January 19, 2017, and No. 1236n dated November 20, 2020. Key updates include refined labelling procedures, evidentiary materials required from manufacturers, and provisions addressing medical devices utilizing artificial intelligence technologies.

This article examines:

• types of documentation developed for medical devices;
• statutory requirements for the content of such documentation;
• structuring the development process;
• potential pitfalls and common drafting errors;
• navigating the process of amending the documentation;
• safeguarding documentation as intellectual property;
• litigating disputes related to such documentation.

Regulatory Framework Governing Medical Device Documentation

The following regulatory acts establish documentation requirements in the Russian Federation:

• Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation ("Law No. 323-FZ" or the "Law on Health Protection");
• Decree of the Government of the Russian Federation No. 1684 dated November 30, 2024, On Approval of the Rules for State Registration of Medical Devices ("Decree No. 1684");
• Order of the Ministry of Health of Russia No. 181n dated April 11, 2025, On Approval of Requirements for the Content of Technical and Operational Documentation of the Manufacturer of a Medical Device ("Order No. 181n").

Furthermore, developers must consider a significant number of standardization documents:

• GOST R 15.013-2016, System of Product Development and Launching into Manufacture. Medical Devices;
• GOST 2.601, Operational Documents;
• GOST R ISO 13485, Medical Devices. Quality Management Systems;
• GOST R ISO 14971, Medical Devices. Application of Risk Management to Medical Devices;
• GOST R IEC 60601-1, Medical Electrical Equipment. General Requirements for Basic Safety and Essential Performance;
• and others.

Currently, the Russian Federation applies the medical device registration procedure under the Eurasian Economic Union (EAEU) law in addition to the national procedure, in accordance with the Decision of the Council of the Eurasian Economic Commission No. 46 dated February 12, 2016, On the Rules for Registration and Expertise of Safety, Quality and Efficacy of Medical Devices. If the manufacturer plans registration under supranational rules, EAEU documents must guide the documentation development. Regulatory authorities plan a gradual phase-out of the national regime and a transition to registration under EAEU rules. However, due to space constraints, this article will not address the rules for developing documentation under EAEU law.

Types of Medical Device Documentation and Content Requirements

Under Part 3 of Article 38 of the Law on Health Protection, the manufacturer shall develop technical and (or) operational documentation for the medical device to govern its manufacturing, production, storage, transportation, installation, setup, application, operation (including maintenance), repair, and disposal or destruction.

One must distinguish between "technical and operational documentation for a medical device" and the "registration dossier for a medical device". Medical device documentation is an integral part of the registration dossier. However, the set of documents comprising the registration dossier is much broader: alongside technical and operational documentation, it includes testing and trial protocols, expert opinions, decisions of the registering authority, and other records.

Medical device documentation consists of two primary blocks:

• technical documentation ("TD");
• operational documentation ("OD").

Technical Documentation for Medical Devices

Technical documentation refers to documents governing the design of a medical device, establishing technical requirements, and containing data for its development, manufacturing, application, operation, maintenance, repair, and disposal or destruction (Paragraph 4 of Decree No. 1684).

GOST R 15.013-2016 lists the documents that may constitute technical documentation. Generally, technical documentation includes:

• Technical Specifications (TS): requirements for the device, its manufacturing, acceptance, and control methods;
• Design Documentation (DD): blueprints, specifications, schematics;
• Testing Program and Methodology (PM): description of compliance verification procedures;
• Technological Documentation (TechD): routing cards, operational cards, assembly instructions;
• Quality Management Documentation: quality policy, SOPs, quality records;
• Risk Management File: risk analysis results;
• Software Documentation (if the medical device incorporates software).

Section II of Order No. 181n outlines the content requirements for technical documentation.

Technical documentation must contain the following information:

• the name of the medical device and other information enabling its identification (including the model/make number);
• the intended purpose and principles of operation;
• indications and contraindications for use;
• information about potential users;
• technical characteristics;
• a description of the main functional elements;
• a description of the components (assemblies);
• a description of accessories and devices intended for use in combination with the medical device;
• information on the absence of interchangeability restrictions;
• details regarding the possibility of combined use with a medical device from another manufacturer, and specific features of such combined use;
• information on whether the medical device contacts the human body surface, mucous membranes, or internal environments;
• labelling and packaging data (including colour mock-ups of packages and labels containing the original text and additional Russian-language labelling applied to medical devices manufactured outside the Russian Federation);
• a list of risks identified during risk analysis and a description of risk management methods;
• verification and validation data used to prove compliance with documents developed and applied within the national standardization system;
• details on the use of materials of animal and (or) human origin;
• evidence regarding the manufacturer's evidentiary materials;
• information on previous modifications of the medical device;
• information on the main design stages and manufacturing processes;
• information on documents confirming the quality of a medicinal product or other substance included in the medical device;
• a description of the sterilization method and sterilization and packaging process validation methods (for sterile devices);
• information on the design, development, and validation process of the software used in the finished medical device;
• maintenance and repair requirements;
• requirements and conditions for disposal or destruction.

In vitro diagnostic medical devices require additional information. Paragraph 4 of Order No. 181n provides this list. Section III of Order No. 181n establishes special requirements for the technical documentation of software constituting a medical device. You can read more about these in our dedicated article.[1]

Because technical documentation contains design and manufacturing details, the manufacturer does not provide it to users, nor does the regulatory authority publish it in the open-access State Register of Medical Devices.

Operational Documentation for Medical Devices

Operational documentation refers to documents designed to familiarize the consumer with the medical device's design, governing the conditions and rules of operation (intended use, maintenance, routine repair, storage, and transportation), manufacturer-guaranteed baseline parameters and characteristics (properties), warranty obligations, and disposal or destruction information (Paragraph 4 of Decree No. 1684).

GOST 2.601 details the list of operational documentation. Operational documentation may include:

• Operating Manual (OM): a document describing the device's design, installation, setup, and maintenance;
• Instructions for Use (IFU): a document containing indications, contraindications, method of administration, and adverse effects;
• Medical Device Passport: a document detailing the manufacturer's warranty, baseline parameters and characteristics, certification, and disposal information;
• Logbook: a document detailing the manufacturer's warranty, baseline parameters and characteristics, technical condition status, certification, disposal information, and operation logs;
• Material consumption rates;
• Spare parts consumption rates, and others.

Developing an OM or IFU is mandatory; the manufacturer determines the necessity of the remaining documents.

Section IV of Order No. 181n mandates the content requirements for operational documentation.

Operational documentation must contain the following information:

• the name of the medical device;
• manufacturer details: name and registered address of the legal entity, or the full name, identity document details, and registered residential address of an individual entrepreneur, along with a telephone number and email address;
• equivalent data regarding the authorized representative of a foreign medical device manufacturer;
• information on the intended purpose, specifying the potential user;
• functional characteristics and performance details;
• information on application risks, contraindications, and adverse effects associated with the intended use;
• technical characteristics;
• a description of accessories or devices intended for use in combination with the medical device;
• information regarding the presence of a medicinal product for medical use, or materials of animal and (or) human origin within the device;
• installation, assembly, configuration, calibration, and other commissioning requirements;
• facility requirements for commissioning, as well as training or qualification requirements for commissioning personnel;
• verification procedures to ensure proper installation and safe operation readiness;
• information on the sterile condition, sterilization method, and protocols for compromised sterile packaging (for sterile medical devices) or, if supplied non-sterile, an instruction to sterilize prior to use;
• processing requirements for reusable medical devices, and criteria for unsuitability for use;
• known limitations for co-use with other medical devices;
• information on the absence of interchangeability restrictions via special hardware, software, or other means;
• details regarding the possibility of combined use with another manufacturer's medical device and specific combined-use features;
• the nature, type, intensity, and distribution of radiation;
• operational precautions;
• circumstances requiring the consumer to consult a healthcare professional;
• the initial issue date or the latest revision date of the operational documentation;
• requirements and conditions for disposal or destruction.

In vitro diagnostic medical devices require additional information. Paragraph 7 of Order No. 181n outlines this list. Section V of Order No. 181n establishes special operational documentation requirements for software constituting a medical device.

The manufacturer supplies operational documentation to the consumer in hard copy (accompanying the medical device or separately) and in electronic format via the Internet. Additionally, the manufacturer may provide electronic operational documentation displayed on a screen integrated into the medical device. For Class 1 and Class 2a potential risk medical devices, the manufacturer may provide an abridged version of the operational documentation, containing only the information strictly necessary for safe intended use.

Technical and operational documentation must be drafted in Russian. If the original is in a foreign language, a duly certified Russian translation is required.

Consequently, the substantial volume and strict content requirements necessitate meticulous preparation. Failure to comply will result in a medical device registration denial.

The Medical Device Documentation Development Process

The documentation development process can be simplified into the following stages:

1. Requirement Analysis and Data Gathering. Developers identify applicable requirements and standards, define the intended purpose and scope of application, perform preliminary potential risk classification, and draft the technical specifications.

2. Technical Documentation Drafting. Based on the technical specifications, the team creates the design documentation, the risk management file, conducts the initial risk analysis, and drafts the TD.

3. Verification and Validation. This phase includes technical tests and studies of prototypes (e.g., per GOST R 50444). The technical documentation is updated based on the results.

4. Operational Documentation Preparation. The team determines the required types of operational documentation and drafts them, alongside the labelling and packaging designs.

5. Approval and Registration Preparation. Upon completing the full documentation suite, the manufacturer conducts internal reviews and approvals before compiling the registration dossier.

Under paragraph 7.3.10 of GOST R ISO 13485, Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes, the manufacturer must maintain a design and development file. This file must include or reference records demonstrating compliance with design and development requirements and records of design and development changes.

Engaging Third Parties in Documentation Development: Structuring the Legal Relationship

In practice, medical device manufacturers rarely develop all documentation entirely in-house. They frequently engage engineering and design firms, consultants, test facilities, technical writers, translators, software developers, and designers. Proper legal structuring of these relationships is critical for ensuring documentation quality and protecting intellectual property rights.

Depending on the scope of work, manufacturers may utilize various contractual structures:

• Research and Development (R&D) agreements for creating a new device prototype or technology, including technical and (or) design documentation;
• Employment agreements (if in-house staff handle the development);
• Contractor agreements (for drafting blueprints, calculations, etc.);
• Service agreements (for consulting and expert support);
• Author's commissioning agreements (for illustrations, operational documentation texts);
• License agreements (for granting rights).

Contractor Agreements for Medical Device Technical and Operational Documentation

When formalizing relationships with external developers, we recommend including the following provisions in the agreement:

1. Subject Matter. The contract must explicitly define the deliverables: specific documentation sections, the list of documents, format requirements, volume, and applicable standards.

2. Deadlines, Milestones, and Acceptance Procedures.

3. Allocation of Intellectual Property Rights. This depends on the chosen structure: it may involve the complete assignment of exclusive rights or the granting of non-exclusive rights (e.g., the right to use by any means).

4. Representations and Warranties. Typically, these include assurances that the documentation does not infringe upon third-party rights and does not incorporate protected third-party intellectual property without authorization.

5. Confidentiality. A Non-Disclosure Agreement (NDA) is a critical component. The contract should list confidential information and stipulate the duration of the confidentiality regime.

6. Liability. Penalties for missed deadlines, confidentiality breaches, and third-party rights infringement.

Parties must also account for specific provisions of the Civil Code applicable to the chosen contract type.

Poorly drafted contracts and improperly executed documentation frequently lead to litigation. A case study illustrates this point.

For instance, in Case No. A72-7155/2021,[2] a Company (Licensee) and citizens K. and S. (Authors) entered into a license agreement whereby the Authors undertook to grant the Licensee the right to use design document packages for the "Blood Center" medical module. Under clause 1.2.1 of the license agreement, the document packages included:

• design documentation;
• operational documentation;
• certification testing protocols;
• technical testing protocols;
• clinical and other testing protocols;
• the registration dossier package.

Subsequently, one of the authors filed a lawsuit demanding the recovery of license fee arrears and a penalty for late payment amounting to 57,070,239 Rubles.

The court established that the medical module was delivered to the healthcare organization prior to the transfer of the documentation under the agreement. The Company was listed as the compiler of the medical device documentation. The plaintiffs presented no documents substantiating the authorship of K. and S. during the proceedings. The court dismissed the claim.

Liability for Documentation Content

Given the multitude of parties involved in developing medical device documentation, a legitimate question arises: who bears liability for its content?

The answer lies in the statutory framework: the manufacturer develops the technical and operational documentation governing the medical device's circulation. This explicitly derives from Article 38 of the Law on Health Protection.

The manufacturer exclusively:

• determines the composition and content of the documentation;
• warrants the accuracy of the stated characteristics, indications, contraindications, and operational principles;
• ensures the documentation aligns with the device's actual design and properties;
• updates the documents when the device or the registry entry changes.

Consequently, the manufacturer – not the third-party developers, the registering authority, or the test facilities – bears full liability for the completeness, accuracy, and currency of the documentation. Entities handling storage, application, or maintenance are solely responsible for complying with the manufacturer's documented instructions.

Violations carry the risk of administrative or criminal liability for the party responsible for documentation development, specifically for circulating falsified, substandard, or unregistered medical devices (Article 6.33 of the Code of Administrative Offenses of the Russian Federation, Article 238.1 of the Criminal Code of the Russian Federation).

Amending Medical Device Documentation

During the commercial lifecycle of a medical device, amending its technical or operational documentation often becomes necessary. Reasons for such updates include design upgrades, IFU revisions, component supplier changes, or error corrections.

Because the documentation is part of the registration dossier, the manufacturer must amend the dossier accordingly. Under Decree No. 1684, depending on the materiality of the updates, these changes may trigger a quality and safety expert review or proceed via a simple notification procedure.

Under paragraph 111 of Decree No. 1684, the following amendments do not require an expert review of quality, efficacy, and safety:

• updates to manufacturer details;
• changes to the manufacturing site's mailing address (e.g., renaming a geographic entity, street, square, or changing numbering/postal codes);
• updates to the manufacturer's authorized representative details;
• modifications to the medical device name regarding trademarks and other means of individualization, or removing the medical device model/make from the registry entry;
• labeling design changes that do not alter the symbols used;
• changes made by a manufacturer of Class 1 or non-sterile Class 2a medical devices that has passed a quality management system assessment (covering design and development processes), provided the changes do not require registering a new medical device;
• classifier code modifications;
• extensions or changes to the validity periods of documents within the registration dossier.

The manufacturer files these changes to the registration dossier via notification. The manufacturer (or its authorized representative) submits an application and a supporting document package to Roszdravnadzor no later than 90 business days after the change occurs. Applicants submit these documents via their personal account on the Unified Portal of State and Municipal Services. Barring any deficiencies, the agency processes the amendments within 18 business days of receiving the application package.

Any amendments not specified in paragraph 111 of Decree No. 1684 trigger a mandatory expert review of safety, quality, and efficacy.

To register such material amendments, the applicant must submit the following documents to Roszdravnadzor within 90 business days of the change:

• an application detailing the amendments;
• copies of documents verifying the authorized representative's credentials (mandatory for foreign manufacturers; domestic manufacturers submit this only if they employ an authorized representative);
• results of clinical trials for the medical device (if applicable);
• documents verifying the availability of manufacturing facilities and (or) copies of quality management system certificates complying with GOST ISO 13485-2017 or ISO 13485:2016;
• copies of previous inspection reports based on the aforementioned standards;
• documents verifying the quality management system's compliance with implementation, maintenance, and evaluation requirements;
• the amended documents themselves.

Following document verification, Roszdravnadzor orders an expert review of the medical device's quality, efficacy, and safety. The expert institution must complete this review within 15 business days of receiving the assignment. Currently, the Center for Expertise and the All-Russian Scientific Research and Testing Institute of Medical Technology conduct these reviews.

Within 10 business days of receiving the expert opinion, Roszdravnadzor issues a decision to either amend the registration dossier or reject the application.

You can read more about the procedure for amending the registration dossier in our dedicated article.[3]

Consequently, prior to amending documentation, companies must assess whether the changes trigger an expert review. When planning production runs under the revised documentation, manufacturers must factor in the lead times required for mandatory testing, studies, and formal registration.

Safeguarding Technical and Operational Documentation as Intellectual Property

Medical device technical and operational documentation constitutes a highly valuable commercial intellectual asset, not merely a mandatory registration dossier component. This dual nature creates a legal friction: the manufacturer must disclose specific information for registration (leading to public domain publication), yet simultaneously seeks to maintain the confidentiality of its most critical proprietary data. Consequently, shielding this documentation against misappropriation is a strategic imperative.

Under Russian law, several intellectual property regimes can concurrently protect documentation:

• Copyright Law;
• Patent Law;
• Trade Secret (Know-how) Law;
• Means of Individualization Rights.

In Letter No. 27-4/429 dated May 24, 2024, the Ministry of Health of Russia issued guidance on the comprehensive protection of medical device developments utilizing various intellectual property rights. According to the Ministry, Patent Law can protect design documentation (blueprints, schematics), Copyright Law can protect the operating manual and instructions for use, and an industrial design patent can protect packaging design. Let us examine these legal regimes in detail.

Copyright Protection for Technical and Operational Documentation

Under Article 1259 of the Civil Code, copyright applies to works of science, literature, and art, as well as derivative and composite works. Technical documentation (blueprints, schematics) and the text of operational documents qualify as works of science and enjoy copyright protection.

The individual whose creative effort produced the work is recognized as the author. The exclusive right to the work vests upon its creation, irrespective of formal registration, and remains valid throughout the author's life plus seventy years post-mortem (Article 1281 of the Civil Code). Therefore, the manufacturer must ensure a proper chain of title from the individual author. Typically, companies execute a deed of assignment to transfer the exclusive right, or a license agreement to grant usage rights.

Notably, copyright strictly protects the literal expression (text/form) of the documentation. Proving infringement of the underlying substance (ideas, methods, concepts) is highly problematic. Consequently, in certain scenarios, invoking alternative intellectual property protections proves far more effective.

Patent Rights for Technical and Operational Documentation

Under Article 1349 of the Civil Code, patentable subject matter encompasses inventions (technical solutions in any field), utility models (technical solutions related to an apparatus), and industrial designs (design solutions). Thus, the device's construction, application methodologies, and packaging design are fully patentable.

To secure protection, the rightsholder must obtain a patent. The applicant files the patent application and supporting dossier with Rospatent. Legal protection attaches exclusively upon state registration and patent issuance. Patent validity periods are: 20 years for inventions, 10 years for utility models, and 5 years for industrial designs (extendable up to 25 years).

While patenting provides robust protection for documentation, it entails substantial administrative burdens and lead times. Moreover, the manufacturer must file for the patent before publishing the documentation. Premature public disclosure destroys the novelty requirement, resulting in an automatic patent denial.

Trade Secrets (Know-How) for Technical and Operational Documentation

Under Clause 1 of Article 1465 of the Civil Code, a production secret (know-how) encompasses any data reflecting intellectual activity in the scientific and technical sphere or outlining professional methodologies, provided the information:

• possesses actual or potential commercial value;
• is unknown to third parties;
• is not legally accessible to the public;
• is subject to a trade secret regime enforced by the rightsholder.

The law recognizes elements of technical documentation – such as material compositions, formulations, technological routing, manufacturing regimens, quality control methods, and sterilization parameters – as protectable know-how.

Protecting know-how requires the implementation and strict enforcement of a trade secret regime. Specifically, the manufacturer must execute the following minimum confidentiality safeguards (Part 1 of Article 10 of Federal Law No. 98-FZ dated July 29, 2004, On Trade Secrets):

• delineate the specific information constituting the trade secret;
• restrict access to this information by establishing handling procedures and monitoring compliance;
• maintain an access log tracking all individuals granted access or provided with the information;
• regulate the use of trade secrets by employees via employment agreements, and by counterparties via civil law contracts;
• affix a Commercial Secret label (including the rightsholder's details) to physical media or document headers containing the information. The trade secret regime legally commences once the rightsholder implements these measures (Part 2 of Article 10 of Federal Law No. 98-FZ).

A trade secret regime provides highly effective protection but demands rigid procedural compliance. A single breach of confidentiality protocols by the manufacturer can instantly void the legal protection.

Means of Individualization Rights for Technical and Operational Documentation

Means of individualization include trademarks, trade names, and commercial designations. Trademarks are the most common vehicle. Under Clause 1 of Article 1482 of the Civil Code, wordmarks, figurative marks, 3D marks, and other designations are eligible for trademark registration.

Much like a patent, a trademark mandates registration with Rospatent. Upon successful registration, Rospatent enters the trademark into the State Register of Trademarks and Service Marks and issues a certificate.

Trademark registration insulates the medical device against competitors deploying confusingly similar product names; however, it also requires assembling a comprehensive registration dossier.

When structuring a legal strategy for intellectual property protection of documentation, we strongly advise deploying the full spectrum of mechanisms provided by current law.

Potential Pitfalls and Common Documentation Errors

A substantial percentage of registration denials stem not from fundamental technical flaws in the device, but from entirely avoidable documentation errors. The following represent the most prevalent pitfalls.

1. Misclassification of the Medical Device. This represents a critical failure point, as the potential risk class dictates the required documentation volume, testing scope, and registration timelines. Common infractions include artificially lowering the risk class to circumvent rigorous registration procedures or ignoring specialized classification criteria governing specific devices (e.g., in vitro diagnostic devices, medical software). Prior to drafting, manufacturers must conduct a rigorous analysis against the Nomenclature Classification of Medical Devices. In ambiguous scenarios, securing a formal clarification from Roszdravnadzor is imperative.

2. Non-Compliance with Regulatory Completeness Requirements. Incomplete dossiers are a primary trigger for summary application rejections. Frequently omitted documents include the Testing Program and Methodology, or the Risk Management File. Counsel must exhaustively audit the prepared documentation against statutory requirements prior to submission.

3. Defective Technical Specifications (TS). The TS acts as the core regulatory blueprint for the device. Routine errors include drafting without reference to active GOST standards (or citing obsolete ones), stark discrepancies between TS-declared specifications and actual performance metrics, vague drafting, or failing to mandate packaging, labeling, storage, and transportation protocols.

4. Deficient Risk Management Files. The Risk Management File is a critical document reflecting the hazard analysis spanning the device's lifecycle. Prevalent errors involve treating the file as a mere formality (lack of genuine risk analysis), incomplete hazard identification, failing to evaluate the aggregate residual risk, and failing to transpose risk warnings into the OM and IFU. Developers must strictly adhere to GOST R ISO 14971-2021, Medical Devices. Application of Risk Management to Medical Devices.

5. Flawed Operating Manuals and Instructions for Use. Manufacturers frequently err by assuming drafting either an OM or an IFU suffices. A secondary error involves drafting the text in overly dense, technical jargon. Because these documents directly instruct the end-user, they must be drafted in clear, accessible language.

6. Contradictions Between Documentation and Labeling. Conflicts arise when the physical labelling diverges from the documentation filed in the registration dossier (a particularly acute risk for imported devices), or when the text is illegible or printed on low-contrast backgrounds.

To mitigate documentation liabilities, manufacturers must adopt a systemic drafting approach, rigorously verifying completeness and alignment with applicable standards. Furthermore, cross-document verification is essential: various documentation elements must not contradict one another.

Litigation Landscape Regarding Medical Device Documentation

A substantial volume of litigation surrounding medical device documentation centers on intellectual property infringement claims.

Intellectual property disputes include, inter alia, claims regarding:

• authorship of an invention, utility model, or industrial design;
• infringement of the exclusive right to an invention, utility model, or industrial design;
• the execution, performance, modification, and termination of exclusive right assignment agreements (patent assignments) and license agreements, as well as the calculation, timing, and disbursement of royalties;
• the seizure and destruction of counterfeit goods.

Under Article 1248 of the Civil Code, courts retain jurisdiction over intellectual property infringement and validity disputes. Commercial disputes tied to entrepreneurial activity fall under the jurisdiction of the Arbitration Courts (Commercial Courts) and proceed under the Arbitration Procedure Code of the Russian Federation (APC RF). Article 34 of the APC RF determines the specific venue. For example, the Intellectual Property Court acts as the court of first instance for actions challenging the regulatory acts of federal executive bodies in the patent sphere. General claims defending exclusive rights to documentation fall under the venue of regional Arbitration Courts, with the Intellectual Property Court serving as the court of cassation for such matters.

Case law provides clear examples. For instance, in Case No. A40-210679/2022,[4] the plaintiff (Rightsholder) and the defendant (Acquirer) executed an exclusive right assignment agreement, obligating the plaintiff to transfer the exclusive right to a production secret. The contract defined this trade secret as the technical and manufacturing specifications detailing the production and application of the Viscoelastic Sterile Synovial Fluid Endoprosthesis. The transfer mechanism consisted of handing over the documentation (technological records, formulas, drafting notes, etc.). The plaintiff subsequently sued to invalidate the contract (declare it non-concluded), arguing that the transfer of technical documentation could not constitute the subject matter of the contract, as physical documents are not freely tradable assets. The court held that the parties correctly defined the subject matter as the assignment of exclusive rights to the medical device's trade secret via the transfer of documented information. The court dismissed the lawsuit.

Another prevalent litigation category involves challenging Roszdravnadzor's decisions to deny medical device registration due to documentation errors.

Plaintiffs litigate these challenges under Chapter 24 of the APC RF. Regional Arbitration Courts hold jurisdiction over these disputes. To prevail, the applicant must establish the following concurrent elements:

• the contested decision, action, or inaction contradicts the law or other regulatory acts;
• the agency violated the applicant's rights and legitimate interests in the sphere of entrepreneurial and other economic activity, or unlawfully imposed obligations, or created other barriers to economic activity.

For example, in Case No. A40-298764/2023, [5] a Company applied to Roszdravnadzor for state registration of a medical device (diagnostic gloves). During the registration review, the expert institution recommended the applicant amend the documentation, specifically:

• add the IFU to the delivery set and exclude the consumer packaging;
• align the consumer packaging labeling with the manufacturer's technical documentation;
• ensure consistency regarding the dusting agent content across the registration dossier;
• provide a substantiated rationale for omitting certain tests.

The Company failed to cure these deficiencies. Consequently, the expert committee concluded that the submitted technical documentation failed to ensure the quality and safety of the medical device. Roszdravnadzor denied registration. The Company sued to invalidate the denial, arguing that the negative expert opinion relied primarily on the failure to integrate the expert institution's recommended standards into the normative documentation. However, the court found that the applicant failed to prove the device complied with the manufacturer's technical and operational documentation. The court dismissed the claim.

In summary, technical and operational documentation forms the foundation of both patient safety and the manufacturer's legal defense. The vast majority of regulatory rejections and delays stem not from inherent product defects, but from manufacturers neglecting documentation quality. A rigorously drafted documentation suite yields substantial returns by accelerating registration timelines, mitigating denial risks, and insulating the manufacturer against regulatory enforcement actions.

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References

1. BRACE Law Firm Website: https://brace-lf.com/informaciya/farmatsevticheskoe-i-meditsinskoe-pravo/programmnoe-obespechenie-meditsinskoe-izdelie-kriterii-registratsii.

2. Resolution of the Arbitration Court of the Povolzhsky District dated October 24, 2023, No. F06-23610/2022 in Case No. A72-7155/2021.

3. BRACE Law Firm Website: https://brace-lf.com/informaciya/farmatsevticheskoe-i-meditsinskoe-pravo/vird-medicinskih-izdelij-nacionalnaya-procedura-rf.

4. Resolution of the Intellectual Property Court dated August 3, 2023, No. S01-1451/2023 in Case No. A40-210679/2022.

5. Resolution of the Arbitration Court of the Moscow District dated March 25, 2025, No. F05-31237/2024 in Case No. A40-298764/2023.