Glossary
Glossary of regulatory terms gives definitions for the main regulatory terms used on this website and in documents. Click on a letter below to see terms beginning with that letter.
Authorized representative
- a legal entity or individual entrepreneur registered on the territory of the Russian Federation, authorized by the manufacturer of a medical device to represent its interests on issues of circulation of a medical device on the territory of the Russian Federation, including on issues of conformity assessment procedures and state registration, in whose name there may be a registration certificate for a medical device was issued (Decree of the Russian government 1416, clause 4)
Amendment in registration certificate
- namely: -changing the information about the applicant (within the framework of the amendments to the registration certificate applicant=manufacturer) -changing information about the person in whose name a registration certificate for a medical device may be issued -changing the address of the place of manufacture of the medical device -changing the name of the medical device in the case if the properties and characteristics affecting the quality, efficiency and safety of the medical device have not changed or its properties and characteristics are improved, while the functional purpose and principle of action remain unchanged (all of the following, as a rule, with expertise): adding accessories to a medical device or changing their names Indication, modification and deletion of the trademark and other means of individualisation of the medical device changing the number of units of a medical device or its parts and components specified in the appendix to the registration certificate (RF Government Decree 1416)
Amendment in registration dossier
- amendments to the documents contained in the registration dossier include: а. Making amendments to the documents contained in the registration dossier that do not require expert examination of the quality, efficiency and safety of the medical device; (paragraph 37 of RF Government Decree1416 regulations) Example: d) changing by the manufacturer of the medical device of the validity terms of the documents contained in the registration dossier f) changing of information about the authorised representative of the manufacturer of the medical device
Biocompatibility trials
- research to assess the biological safety of a medical device and make a subsequent decision on the possibility of conducting clinical trials (Decree of the Russian government 1416, clause 4)
Clinical trials
- a designed and planned systematic study undertaken, including involving human subjects, to evaluate the safety and effectiveness of a medical device; Clinical trials of medical devices are carried out in the form of evaluation (hereinafter referred to as analysis and evaluation of clinical data) and in the form of trials, including those involving humans (hereinafter referred to as trials involving humans), carried out to assess the safety and effectiveness of a medical device. Tests of medical devices involving humans are carried out in the following cases: a) a new type of medical device; b) the use of new complex and (or) unique and (or) special methods of prevention, diagnosis and treatment of diseases and conditions, as well as the use of new complex medical technologies; c) if the analysis and evaluation of clinical data does not confirm the effectiveness and safety of the medical product; d) for medical products containing new materials that come into contact with the human body, previously not studied in terms of biological effects, or known materials that come into contact with those human organs or tissues for which there is no experience of their medical use, or in the event that such contact is longer than previously studied. In other cases, clinical trials of medical devices are carried out in the form of analysis and evaluation of clinical data (Decree of the Russian government 1416, clause 4; Decree of the Ministry of Health 885n, clause 36)
Expert center
From the proposal in RF Government Decree N1416: "to the federal state budgetary institution that reports to the registration authority " Formally, three subordinate institutions are under the jurisdiction of the RZN: FSBI "VNIIIMT" of Roszdravnadzor FSBI "NQI" (or NIK) of Roszdravnadzor FSBI "IMTSEUAOOSMP " Roszdravnadzor ( RF Government Decree 1416, p. 20)
Factory site (production site for medical device)
- a territorially isolated complex designed to carry out the entire production process of a medical device or its certain stages (from Decree of the Russian government 135, clause 2)
Holder of registration certificate
- There is no definition. In the RF Government Decree 1416 (so called Order 1416) appears only in clause 9 about the statement, in clause 37 about amendment processes, clause 56 about information in the form, clause 5 about notification about type code change, in clause 4 in definition of AR (that it can be a holder). At the level of “speculation” one can write that this is any legal entity or individual entrepreneur (of any country), that will be indicated in the form as “the person in whose name the RС was issued, the duties and rights of the regulatory documentation are not defined".
IVD MD
– any devices, instruments, equipment, materials, reagents, calibrators, control materials and other products used for medical purposes individually or together, as well as together with accessories and special software necessary for their intended use, and intended by the manufacturer for use in in vitro studies of human biological samples to obtain information regarding physiological or pathological conditions (congenital pathology, predisposition to a particular clinical condition or disease), tissue compatibility with a potential recipient, predicting responses to therapeutic interventions, selection of therapeutic agents and/or ) treatment control (SEEC Decision No. 46 (as amended in SEEC Decision 144), clause 2)
IFU
- is operational documentation, provided for disposable medical devices. "manufacturer's operational documentation" - the documents intended to introduce the consumer to a medical device design, which govern operating conditions and rules (intended use of the medical device, maintenance, current repairs, storage and transportation), values of the main parameters and features (properties) of the medical device guaranteed by the manufacturer, the warranty policy, as well as information about its disposal or destruction; (in accordance with RF Government Decree 1416) Requirements for the content of operational documentation are specified in Order No. 11n. see paragraph 6. for MD except for Software and in vitro diagnostic products. See Section IV. paragraph 9. for Software, which is medical.
Legal manufacturer of medical device
- a term with different definitions, there are also difficulties with the equivalence of the term developer (producer) “manufacturer of a medical device”, “manufacturer” - a legal entity or an individual registered as an individual entrepreneur, responsible for the development and manufacture of a medical device, making it available for use on its own behalf, regardless of whether the medical device is developed and (or) manufactured by this person or on his behalf by another person (persons), and are responsible for the safety, quality and effectiveness of the medical device (Decision No. 46 of the Council of the EEC (as amended by the Decision 144 the Council of the EEC), paragraph 2)
Medical device
- Medical devices are any devices, instruments, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the condition of the human body, conducting medical research, restoration, replacement, changing the anatomical structure or physiological functions of the body, preventing or terminating pregnancy, the functional purpose of which is not realized through pharmacological, immunological, genetic or metabolic effects on the human body. Medical devices can be recognized as interchangeable if they are comparable in functionality, quality and technical characteristics and are capable of replacing each other (Federal law 323, Article 38, clause 1)
Passport
- or technical passport for a medical device is prepared if the medical device is manufactured in the territory of the Russian Federation in accordance with GOST 2.114-2016, i.e. in accordance with technical specifications (TS). Technical specifications in accordance with GOST 2.102 are design documentation (DD) containing requirements (a set of all indicators, norms, rules and regulations) for the device, its manufacture, control, acceptance and delivery, which are not expedient to specify in other DDs.
Registration certificate
- A document confirming the fact of state registration of a medical device is a registration certificate for a medical device (Decree of the Russian government 1416) Please, also note that the RC itself loses its significance. And in the near future it will most likely be replaced by a registry entry.
RZN or Roszdravnadzor
- The Federal Service for Surveillance in Healthcare (Roszdravnadzor) is a federal executive body exercising control and supervision functions in the healthcare sector (Federal law 323, clause 1)
Registration dossier
- a set of documents submitted for state registration, amendments to such documents, also copies of decisions made by the registration authority in regard to a particular medical device; Paragraph 54. Decree 1416 describes the contents of the registration dossier.
Technical trials
- tests to determine compliance of the characteristics (properties) of a medical device with the requirements of regulatory documentation, technical and operational documentation of the manufacturer and make a subsequent decision on the possibility of conducting clinical trials (Decree of the Russian government 1416, clause 4)
Technical file
- or " technical documentation of the manufacturer " - documents regulating the design of a medical device, establishing technical requirements and containing data for its development, production, use, operation, maintenance, repair, disposal or destruction; The requirements for the content of technical documentation are specified in Order No. 11n see paragraph 4. for MD except for Software and in vitro diagnostic products. See paragraph 5_1 of section II_1 for software , which is a medical device.
Technical trials laboratory
- (or a laboratory that conducts technical tests of a medical device for the purpose of registration) a legal entity that is accredited in the territory of the Russian Federation and can conduct technical tests in accordance with its accreditation scope (tests in accordance with Order 885n). See point 3. The accreditation of the laboratory can be viewed in the register of Federal Accreditation Service "Accredited Bodies" https://pub.fsa.gov.ru/ral. In the case of the EAEU, it is also necessary to check the availability of the laboratory in the register of Roszdravnadzor "Information on Testing Laboratories (Centres) Authorised to Conduct Technical Tests of Medical Devices for the Purposes of their Registration within the Eurasian Economic Union*" https://roszdravnadzor.gov.ru/services/test_tech. *The full list of organisations is available in the Unified Register of Authorised Organisations entitled to conduct research (tests) of medical devices for the purposes of their registration, placed in the open part of the Union's information system in the sphere of medical devices circulation". https://portal.eaeunion.org/sites/odata/_layouts/15/Registry/PMM07/TableView.aspx
User manual
- is operational documentation, provided for reusable products. "manufacturer's operational documentation" - the documents intended to introduce the consumer to a medical device design, which govern operating conditions and rules (intended use of the medical device, maintenance, current repairs, storage and transportation), values of the main parameters and features (properties) of the medical device guaranteed by the manufacturer, the warranty policy, as well as information about its disposal or destruction; (in accordance with RF Government Decree 1416) Requirements for the content of operational documentation are specified in Order No. 11n. see paragraph 6. for MD except for Software and in vitro diagnostic products. See Section IV. paragraph 9. for Software, which is medical.