Technical and Operational Documentation Development
Conformity assessment, development and writing of a technical and operational documentation, verification and correction of documents prepared by the Manufacturer
Overview of Manufacturer’s Technical and Operational Documentation Requirements
As per Section 4 of the Rules for the State Registration of Medical Devices (Registration Rules) established by the Russian Federation Government Resolution No. 1416 of December 27, 2012:
- The manufacturer’s technical documentation includes documents regulating the design of the medical device, setting technical requirements, and containing data for its development, production, application, operation, maintenance, repair, disposal, or destruction.
- Manufacturer’s operational documentation refers to documents for informing the user about the medical device’s design and rules for operation (intended use, maintenance, routine repairs, storage, and transportation), along with guaranteed manufacturer values for key parameters, warranty obligations, and information on disposal or destruction.
Technical Documentation Requirements in Russia
Technical requirements in the documentation for registered medical devices typically include:
- Purpose requirements, defining the device’s properties and main functions.
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Composition and structure requirements (chemical, fractional, impurity concentration, component content, etc.), physical, chemical, mechanical, and other properties (strength, hardness, heat resistance, wear resistance, etc.).
- Characteristics like geometrical, biological, electromagnetic, electrical, metrological, and strength.
- Software requirements (if included in the device).
- Reliability requirements for performing functions with prescribed efficiency and maintaining them under proper maintenance, repair, storage, and transport conditions.
- Design requirements.
- Material requirements, types of coatings (metallic and non-metallic), and their functional purposes (e.g., corrosion protection).
- Resistance requirements to external impacts (mechanical, climatic).
- Raw materials, materials, and purchased product requirements.
- Requirements encompassing all types of identified hazards (from risk management) and ensuring device safety over its lifespan.
The Importance of Properly Prepared Technical Documentation
Technical documentation is a mandatory part of the registration dossier (Section 10 of the Registration Rules) and, alongside operational documentation, is a key component of the registration documents set.
Documents must align with the Ministry of Health of the Russian Federation Order dated January 19, 2017, N 11n “On approval of the requirements for the content of technical and operational documentation of a medical device”.
Developing technical documentation for a medical device is a pivotal step in the state registration procedure. It defines the characteristics that ensure the device’s quality, safety, and efficacy.
Accredited laboratories must confirm the device’s compliance with technical documentation during testing and assess the operational documentation’s adherence to technical requirements. Following dossier submission, Roszdravnadzor will verify the technical documentation’s compliance with applicable standards and regulatory documents.
Therefore, technical documentation is foundational to the registration process. Its development requires the involvement of highly skilled professionals with broad competencies and relevant experience, making it one of the most sought-after and current services.
Technical Documents From The Manufacturer
- Technical Documentation*
- Operational documentation*
- MD validation and verification report or Qualification test Act and report
- Risk management report
- Usability engineering file
- Software validation and verification report
* Documents must be prepared in accordance with Order of the Ministry of Health of the Russian Federation dated January 19, 2017 N 11n “On approval of the requirements for the content of technical and operational documentation of the manufacturer of a medical device”.
To develop the above documents listed below, the following documents will be required:
Technical Documentation (for foreign manufacturer) or Technical Conditions (for Russian manufacturer)
- Summary set of technical documentation: STED (Summary Technical Documentation), information about the composition of the medical device and its accessories; technical characteristics of the MD and all its components and accessories; drawings with detailed information about the components, its construction, with information about dimensions, etc.;
- Information about the materials from which the medical devices and components are made (only for MD directly or indirectly in contact with the human body);
- Information about the packaging of the medical device;
- Clinical evaluation report (CER);
- Essential Requirements;
- test reports for applicable standards (e.g. EMC, all applicable reports from the group of standards IEC 60601-1, IEC 62366, IEC 62304, etc.).
Operational documentation
- Operating manual (instructions for use); various brochures, booklets, etc.;
- Information about recycling and destruction of MD; information about the principle of action and method of application; information about indications, contraindications, side effects, warnings and precautions, disposal method, etc.
To develop the above documents listed below, the following documents will be required:
Medical device validation and verification reports or Qualification tests Act
- Medical device validation and verification reports
- Qualification test report
Risk management report
- Risk management file (system + software), risk matrix, risk analysis, risk summary (ISO 14791), etc.
Usability engineering file
- Usability engineering file IEC 62366 / IEC 60601-1-6
Software validation and verification report
- Information about the software (validation and verification report (including software life cycle), development, design, architecture, name of the software, its version and release date)
Operational Documentation Development
The medical device’s operational documentation directly influences not only the successful completion of its state registration but also its subsequent safe and effective use by healthcare professionals and non-professional users.
Developing operational documentation for a medical device is a complex process that must consider the requirements of the technical documentation, Order 11n, the experience of previously registered similar devices, and recommendations from medical staff and general users.
Operational documentation prepared for the registration dossier must undergo checks for compliance with applicable requirements during technical and clinical trials and during evaluations by Roszdravnadzor subordinate organizations (FSBI “NIK”, FSBI “VNIIMT”).
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