04/01/2023 | EAEU Decisions
Recommendation of the Board of the Eurasian Economic Commission of October 8, 2019 No. 29 "On the Guidelines on the Content and Structure of Documents of a Medical Device Registration Dossier"
BOARD OF THE EURASIAN ECONOMIC COMMISSION
RECOMMENDATION
of 8 October 2019 No. 29
ON METHODOLOGICAL GUIDELINES
ON THE CONTENT AND STRUCTURE OF DOCUMENTS
OF THE MEDICAL DEVICE REGISTRATION DOSSIER
The Board of the Eurasian Economic Commission, in accordance with Article 31 of the Treaty on the Eurasian Economic Union of 29 May 2014 and Article 4 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of 23 December 2014,
for the purpose of establishing uniform approaches to the registration dossier and the content and structure of documents contained in the registration dossier for medical device registration,
recommends that the Member States of the Eurasian Economic Union, from the date of publication of this Recommendation on the official website of the Eurasian Economic Union, apply the Methodological Guidelines on the Content and Structure of Documents of the Medical Device Registration Dossier as set out in the Annex.
Chairman of the Board
of the Eurasian Economic Commission
T. SARKISYAN
Annex
to Recommendation of the Board
of the Eurasian Economic Commission
of 8 October 2019 No. 29
METHODOLOGICAL GUIDELINES
ON THE CONTENT AND STRUCTURE OF DOCUMENTS
OF THE MEDICAL DEVICE REGISTRATION DOSSIER
1. These Methodological Guidelines have been developed for the purpose of providing methodological assistance to applicants in preparing the set of documents and materials for medical device registration (hereinafter — the registration dossier) in accordance with Annex No. 4 to the Rules for Registration and Assessment of the Safety, Quality and Efficacy of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission of 12 February 2016 No. 46 (hereinafter — the Registration Rules).
These Methodological Guidelines provide clarification of the requirements for the content and structure of registration dossier documents.
2. For the purposes of applying these Methodological Guidelines, the country of origin of a medical device means the country in which the medical device was manufactured or sufficiently processed in accordance with the criteria defined by the Rules for Determining the Origin of Goods Imported into the Customs Territory of the Eurasian Economic Union (Non-Preferential Rules of Origin), approved by Decision of the Council of the Eurasian Economic Commission of 13 July 2018 No. 49.
Other terms used in these Methodological Guidelines shall be applied in the meanings defined by the acts of the Eurasian Economic Union (hereinafter — the Union) bodies in the field of medical device circulation.
3. For the purpose of assessment and registration of a medical device, the applicant shall submit (send) to the competent authority (expert organisation) of the reference state the following documents:
1) the registration dossier on electronic media. Where the legislation of a Union Member State (hereinafter — Member State) does not provide for the possibility of executing such documents in electronic form, the competent authority of the reference state may request such documents (or copies thereof) in hard copy. In this case, documents submitted in a foreign language shall have an authentic translation into Russian certified in the manner established by the legislation of the reference state.
Information on the conformity of the data contained in the registration dossier with the technical file data structure for the medical device is set out in the Annex to the Methodological Guidelines for Conducting the Safety, Quality and Efficacy Assessment of Medical Devices for the Purpose of Their Registration within the Eurasian Economic Union (Annex to Recommendation of the Board of the Eurasian Economic Commission of 21 May 2019 No. 14);
2) copies of documents confirming payment for the assessment and registration of the medical device in the reference state.
The applicant shall bear the costs of the assessment and registration of the medical device in accordance with the legislation of the reference state, and the costs of endorsement of the expert conclusion in accordance with the legislation of the states of recognition.
4. The documents referred to in paragraph 3 of these Methodological Guidelines shall be submitted by the applicant to the competent authority (expert organisation) of the reference state in hard copy, either in person or by registered mail with acknowledgement of receipt and a contents list, or in electronic form, including on electronic media, in accordance with the Requirements for the Electronic Format of Applications and Registration Dossier Documents Submitted for Medical Device Registration and Assessment of Safety, Quality and Efficacy, approved by Decision of the Board of the Eurasian Economic Commission of 30 June 2017 No. 78.
The applicant shall ensure the completeness, accuracy, clarity and accessibility of the information provided, as well as the timeliness of its submission.
The applicant shall be responsible for the accuracy of the information and data contained in the registration dossier submitted to the competent authority (expert organisation).
5. The documents referred to in paragraph 3 of these Methodological Guidelines shall be accepted by the competent authority (expert organisation) of the reference state against an inventory, a copy of which bearing a note of the acceptance date shall be provided to the applicant or sent by registered mail with acknowledgement of receipt or in electronic form.
6. As part of the registration dossier, the applicant shall submit the following documents provided for in Annex No. 4 to the Registration Rules:
1) application — applications for the assessment and registration of a medical device in the forms set out in Annexes No. 2 and 3 to the Registration Rules, completed and certified on the official letterhead (if any) of the applicant.
In the information on the manufacturer (paragraph 12 of the assessment application form and paragraph 8 of the registration application form provided for in Annexes No. 2 and 3 to the Registration Rules respectively), the country shall be determined taking into account the place of registration of the manufacturer on whose behalf the medical device is placed on the market within the customs territory of the Union.
When indicating information on the manufacturing site(s) (paragraph 13 of the assessment application form and paragraph 9 of the registration application form provided for in Annexes No. 2 and 3 to the Registration Rules respectively), the definition of "manufacturing site" established in the nineteenth paragraph of paragraph 3 of the Registration Rules shall apply. In this context, specific stages of the manufacturing process shall mean:
manufacture of the complete medical device or its main units, other than main units that are medical devices registered in the established manner in the Union, at territorially separate facilities within the organisational structure of the medical device manufacturer;
manufacture of the complete medical device or its main units under contracts with a third-party manufacturer (contractor), other than main units that are medical devices registered in the established manner in the Union;
sterilisation of the medical device;
2) power of attorney from the manufacturer authorising the representation of interests in registration (where required) — the power of attorney shall be executed in accordance with the legislation of the reference state. For the manufacturer's authorised representative, the power of attorney shall grant the right to represent the manufacturer's interests, including in the registration of medical devices, as well as in respect of responsibility for the circulation of the medical device within the Union and compliance with mandatory requirements applicable to medical devices;
3) copy of the authorisation document for the right to manufacture in the country of manufacture with annex (if available) — a document issued by the competent authority, specifying the number and date of issue, granting the right to carry out the relevant type of activity and containing information on the addresses of the places of the relevant activity (if available, where required by the legislation of the manufacturer's country);
4) copies of certificates for the quality management system of the medical device manufacturer (ISO 13485 or the equivalent regional or national standard of a Member State) (if available) — documents issued in the name of the manufacturer (manufacturing site) confirming the implementation by the manufacturer (manufacturing site) of a quality management system for the manufacture of medical devices in accordance with the requirements of standards equivalent to the international standard ISO 13485;
5) declaration of conformity with the safety and efficacy requirements for medical devices or equivalent document (if available) — a document or its copy confirming the medical device's conformity with mandatory requirements of states that are not Union members (e.g., European Union directives or regulations);
6) copy of the registration certificate (free sale certificate, export certificate (except for medical devices first manufactured on the territory of a Member State)) issued in the country of manufacture (if available) with a translation into Russian;
7) copy of the document confirming registration in other countries (if available) — provided for information on the registration of the medical device in other states. Information on registration in other countries may be provided with reference to sources of such information (e.g., reference to a database or other information arrays contained in information systems);
8) medical device product summary describing the field of application, intended use, brief description, variants and accessories (in prescribed form) — compiled in the form provided for in Annex No. 4 to the Registration Rules, describing brief data on the medical device, including the completeness of the medical device broken down into main units (parts), accessories, consumables and components in accordance with the Criteria for Distinguishing Elements of a Medical Device that Are Components of a Medical Device for Registration Purposes, approved by Decision of the Board of the Eurasian Economic Commission of 24 July 2018 No. 116;
9) labelling and packaging data (full-colour packaging and label layouts, labelling text in Russian and the official languages of Member States) — data submitted in accordance with the medical device labelling requirements pursuant to paragraphs 58–63 and 105 of the General Safety and Efficacy Requirements for Medical Devices, Requirements for Their Labelling and Operational Documentation, approved by Decision of the Council of the Eurasian Economic Commission of 12 February 2016 No. 27 (hereinafter — the General Requirements). Photographic images of the general view of the medical device and the accessories required for its intended use may also be provided;
10) information on design and manufacture: manufacturing process flowcharts, key manufacturing stages, packaging, testing and finished product release procedure — information provided by the manufacturer in free form describing the manufacturing process (possibly in the form of flowcharts) with indication of the manufacturing site(s), as well as the country of origin, determined taking into account the place of origin of the main unit(s) of the medical device in accordance with the Rules for Determining the Origin of Goods Imported into the Customs Territory of the Eurasian Economic Union (Non-Preferential Rules of Origin);
11) information on the manufacturer: name, type of activity, legal address, form of ownership, management composition, list of divisions and subsidiaries with indication of their status and powers — copies of the legal entity registration document in accordance with the legislation of the manufacturer's country, the articles of association, etc. may be submitted as such information;
12) marketing information (market history, provided the device has been on the market for more than 2 years) (if available) — (provided for medical devices of potential risk classes 2b and 3) information submitted in free form indicating the time of market entry of the medical device, the markets in which the medical device is in circulation, and the approximate total number of medical devices released;
13) reports on incidents and withdrawals (information is not provided for newly developed and designed medical devices): a list of adverse events or incidents related to the use of the device with indication of the time period during which such events occurred; where adverse events are too numerous, brief summaries for each type of event and the total number of events of each type reported shall be provided; a list of medical device market withdrawals and/or advisory notices and a description of the approach taken by manufacturers to address and resolve such issues in each case; a description of the analysis and/or corrective actions taken in response to such events — (not provided for in vitro diagnostic medical devices of potential risk class 1) a document on adverse events (incidents) occurring at all stages of medical device circulation within the Union and on the territories of non-Union states, compiled by the manufacturer in free form;
14) list of standards with which the medical device complies (with details thereof) — a document indicating the designations and names of standards included in the list of standards, the voluntary application of which fully or partially ensures conformity of medical devices with the General Safety and Efficacy Requirements for Medical Devices, requirements for their labelling and operational documentation (Annex to Recommendation of the Board of the Eurasian Economic Commission of 4 September 2017 No. 17), or other standards applied to prove medical device conformity with the General Requirements. Where a standard is not applied in full, the structural elements of such standard shall be indicated;
15) information on the medical device's conformity with the general safety and efficacy requirements for medical devices, requirements for their labelling and operational documentation — information submitted in the form provided for in Annex No. 2 to the General Requirements. Evidentiary materials (documents), including test (study) reports and information on proprietary test methods, shall be provided as annexes to the said form or as standalone dossier documents;
16) document establishing requirements for the technical characteristics of the medical device — a document compiled by the manufacturer containing the key characteristics of the medical device (e.g., technical specifications, organisational standards, specifications);
17) technical test reports conducted for the purpose of proving conformity with the General Requirements — (not provided for reagents and reagent kits) test reports for the medical device issued by organisations included in the unified register of authorised organisations entitled to conduct research (testing) of medical devices for registration purposes, executed in accordance with the Annex to the Rules for Conducting Technical Tests of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission of 12 February 2016 No. 28;
18) biological effect evaluation study (test) reports conducted for the purpose of proving conformity with the General Requirements — study (test) reports for the medical device issued by organisations included in the unified register of authorised organisations entitled to conduct research (testing) of medical devices for registration purposes, executed in accordance with the Annex to the Rules for Conducting Research (Tests) for the Purpose of Assessing the Biological Effects of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission of 16 May 2016 No. 38.
When assessing the biological effects of a medical device, it is recommended to use the algorithm for planning biological effect evaluation studies (tests) in accordance with Annex No. 1.
Where the available data on the materials of the medical device and/or accessories in contact with the surface of the human body, its mucous membranes or internal body environments are sufficient to prove conformity with the General Requirements, biological effect evaluation studies (tests) need not be conducted. In this case, the applicant shall submit to the competent authority (expert organisation) of the reference state, as part of the dossier, a biological evaluation report forming part of the risk analysis report and containing data justifying the absence of the need to conduct biological effect evaluation studies (tests);
19) clinical evidence report on the efficacy and safety of the medical device — (not provided for in vitro diagnostic medical devices of potential risk class 1) shall contain an analysis and assessment of all available clinical data (both favourable and unfavourable) on the basis of which conclusions on clinical safety and efficacy are drawn in accordance with the requirements established in the Rules for Conducting Clinical and Clinical-Laboratory Tests (Studies) of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission of 12 February 2016 No. 29. The clinical evidence report on the efficacy and safety of the medical device shall be kept up to date taking into account data obtained in the course of post-market surveillance and/or upon the emergence of new confirmed information from scientific literature on the clinical use of the medical device relating to its safety and efficacy, and shall contain data on all identified adverse events (incidents) and contraindications. The current version of the report shall be submitted to the competent authority (expert organisation) of the reference state upon request.
The information indicated in the medical device instructions for use shall correspond to the data contained in the clinical evidence report on the efficacy and safety of the medical device. Where the medical device has been used only in respect of specific patient groups, this shall be indicated in the clinical evidence report and the instructions for use.
It is recommended that the clinical evidence report on the efficacy and safety of the medical device be endorsed by a medical specialist in the field of medical application of the medical device. The qualifications of the medical specialist shall be confirmed by a document on medical education and specialisation in accordance with the field of medical application of the medical device (specialist certificate, diploma, etc.) and by the medical specialist's publications (scientific articles, monographs, dissertations in the field of medical application of the medical device).
The recommended structure of the clinical evidence report on the efficacy and safety of the medical device is set out in the Methodological Guidelines for Conducting the Safety, Quality and Efficacy Assessment of Medical Devices for the Purpose of Their Registration within the Eurasian Economic Union (Annex to Recommendation of the Board of the Eurasian Economic Commission of 21 May 2019 No. 14).
The data in the clinical evidence report on the efficacy and safety of the medical device shall be presented in accordance with the instructions set out in Annex No. 2;
20) risk analysis report — (not provided for medical devices of potential risk class 1) a document compiled by the manufacturer in which all qualitative and quantitative characteristics that may affect the safety of the medical device have been identified, hazards associated with the use of the medical device have been determined both under normal operating conditions and in the event of a malfunction or other event that may lead to hazardous situations and cause harm to human life, health or the environment, and the associated risks have been assessed. In accordance with paragraph 4 of the General Requirements, the manufacturer shall demonstrate that it assesses and manages risks so that residual risks are acceptable.
For specific hazards and hazardous situations identified by the manufacturer that are defined by medical device safety standards listed in the list of standards, the voluntary application of which fully or partially ensures conformity of medical devices with the General Safety and Efficacy Requirements for Medical Devices, requirements for their labelling and operational documentation (Annex to Recommendation of the Board of the Eurasian Economic Commission of 4 September 2017 No. 17), the manufacturer need not determine or assess the associated risks. In this case, compliance with the requirements of such standards may be considered a validated risk control measure.
To prove conformity of a medical device of potential risk class 1 with the provisions of Section II of the General Requirements, manufacturers may refer to the existing risk analysis report;
21) data on medicinal products incorporated in the medical device (composition of the medicinal product, quantity, data on the compatibility of the medicinal product with the medical device, registration of the medicinal product in the country of manufacture) — information indicated in the manufacturer's technical documentation, including the date and registration number of the medicinal product incorporated in the medical device in the country of manufacture of the medicinal product. Data on the compatibility of the medicinal product with the medical device may be provided by reference to the relevant dossier documents;
22) biological safety data (if available) — information on materials of animal or human origin, nanoparticles, genetically modified organisms and other newly developed materials incorporated in the medical device, as well as information on the selection of sources (donors), material sampling, processing, storage, testing, validation of testing procedures, and handling of tissues, cells, substances of animal or human origin, cultures of microorganisms and viruses;
23) data on the sterilisation procedure, including process validation information, bioburden testing results, pyrogenicity and sterility testing results (where required) with indication of test methods, and packaging validation data (for sterile devices) — (not provided for in vitro diagnostic medical devices of potential risk class 1) a document compiled by the manufacturer in accordance with the requirements of regulatory documents applicable to the medical device being registered (e.g., standards);
24) information on special software (if available): manufacturer's data on software validation — a document compiled by the manufacturer in accordance with the requirements of regulatory documents applicable to the medical device being registered (e.g., standards);
25) stability study report (with an authentic translation into Russian of the test results and conclusions, for devices with a shelf life) — a document compiled by the manufacturer in accordance with the requirements of regulatory documents applicable to the medical device being registered (e.g., standards), confirming the ability of the medical device to retain its chemical and physical properties within defined limits throughout the shelf life (with indication of temperature conditions, humidity, number of samples, batch and manufacture date). Contains data necessary to confirm the stability of the device and its components (e.g., reagents, cartridges) during their scheduled use (under real or artificially created conditions). Data on the stability of opened vials and/or on-board reagent stability may be included. Information recommended for inclusion in this report includes:
justification for the choice of studies conducted;
all results obtained from the studies conducted, data analysis and justification of acceptance criteria;
justification that the safety or efficacy of the medical device does not change under the storage conditions established in the manufacturer's documentation.
For medical devices for which no shelf life is established (e.g., electro-medical equipment or other reusable devices), information on the assessment of the average service life or accelerated ageing stability reports may be submitted. Service life information may be provided, for example, in the form of data on the number of procedures that can be performed with the medical device within a given period of time;
26) operational document or instructions for use of the medical device in the official languages of the states of recognition (where required) and in Russian — a document compiled by the manufacturer containing information in accordance with the General Requirements, which may include, inter alia, the operating manual, medical use procedure, passport, logbook, and instructions for assembly, commissioning, maintenance, repair, transport, storage and disposal of the medical device;
27) service manual (in respect of medical device components) — where such data are absent from the operational documentation (if available) — a document compiled by the manufacturer regulating the procedure for servicing the medical device, supplementing the operational document or instructions for use where necessary;
28) manufacturing inspection report (if available) — a document compiled by the inspecting organisation in accordance with the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Application, approved by Decision of the Council of the Eurasian Economic Commission of 10 November 2017 No. 106;
29) post-market safety and efficacy data collection and analysis plan — a document compiled by the manufacturer for medical devices of all potential risk classes. The post-market safety and efficacy data collection and analysis plan may provide for data collection methods such as consumer feedback on experience with the medical device, user surveys, records of oral survey results, and other forms and reports in accordance with the documented customer feedback procedure provided for by the enterprise's quality management system.
The post-market safety and efficacy data collection and analysis plan shall also indicate the timelines for all activities.
The post-market safety and efficacy data collection and analysis plan for in vitro diagnostic medical devices is applicable for confirming their analytical and clinical performance;
30) documents confirming the results of type approval testing of medical devices classified as measuring instruments (in respect of medical devices included in the list of types of medical devices subject to classification as measuring instruments upon registration, approved by Decision of the Council of the Eurasian Economic Commission of 12 February 2016 No. 42) (where required) — documents containing test result data issued by organisations authorised (notified) in accordance with the legislation of a Member State to conduct testing of measuring instruments.
Annex No. 1
to the Methodological Guidelines
on the Content and Structure
of Documents of the Medical Device
Registration Dossier
ALGORITHM
FOR PLANNING BIOLOGICAL EFFECT EVALUATION
STUDIES (TESTS) FOR A MEDICAL DEVICE
7. The documents referred to in subparagraphs 2–4 and 6 of paragraph 6 of these Methodological Guidelines shall be certified in accordance with international certification norms or certification norms established by the legislation of the reference state.
In countries party to the Convention Abolishing the Requirement of Legalisation for Foreign Public Documents of 5 October 1961, documents shall bear an apostille; in countries that are not party to the said Convention, documents shall be legalised through consular services (notarised); in countries party to the Convention on Legal Assistance and Legal Relations in Civil, Family and Criminal Matters of 22 January 1993, documents shall be notarised.
8. The documents referred to in subparagraphs 1, 7–16, 19–27 and 29 of paragraph 6 of these Methodological Guidelines shall be certified by the manufacturer (or its authorised representative).
9. Where registration dossier documents are submitted in electronic form (or as electronic copies of documents), they shall meet the following requirements:
(a) documents referred to in subparagraphs 1, 7–16, 19–29 of paragraph 6 of these Methodological Guidelines shall be submitted in *.pdf format with a text layer allowing text selection, copying and searching;
(b) documents referred to in subparagraphs 2–6, 17, 18 and 30 of paragraph 6 of these Methodological Guidelines shall be submitted in *.pdf format with a resolution of at least 300 dpi;
(c) the size of any individual file in the registration dossier shall not exceed 100 MB in accordance with the Rules for Electronic Data Exchange in the Integrated Information System for External and Mutual Trade, approved by Decision of the Board of the Eurasian Economic Commission of 27 January 2015 No. 5. Where a document exceeds this size, it may be split into several files;
(d) all registration dossier documents shall include the "document issuance date" requisite.
Annex No. 2
to the Methodological Guidelines
on the Content and Structure
of Documents of the Medical Device
Registration Dossier
INSTRUCTIONS
FOR PRESENTING DATA IN THE CLINICAL EVIDENCE REPORT
ON THE EFFICACY AND SAFETY OF A MEDICAL DEVICE
1. The clinical evidence report on the efficacy and safety of a medical device shall contain information on the clinical safety and efficacy of the medical device based on all available clinical data on the medical device, and may consist of several sections (where clinical data have been obtained by different methods).
The manufacturer shall independently determine the list of sections of the clinical evidence report on the efficacy and safety of a medical device based on the methods it has applied to obtain clinical data.
2. Clinical data on a medical device shall indicate the timelines, objectives and goals of the clinical or clinical-laboratory tests (studies), patient groups, patient selection criteria, adverse events (incidents) identified during the clinical or clinical-laboratory tests (studies), the type of tests conducted (e.g., tests conducted for registration purposes or post-registration tests conducted on the territories of states that are not members of the Eurasian Economic Union (hereinafter — the Union)), the statistical data obtained from the clinical or clinical-laboratory tests (studies), the materials and methods used during the clinical or clinical-laboratory tests (studies), the names of the medical organisations in which the clinical or clinical-laboratory tests (studies) were conducted, and other information in accordance with international Good Clinical Practice requirements.
3. Clinical data on a medical device obtained from clinical or clinical-laboratory tests (studies) conducted in the Union in accordance with the Rules for Conducting Clinical and Clinical-Laboratory Tests (Studies) of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission of 12 February 2016 No. 29, shall be accompanied by the clinical or clinical-laboratory test (study) protocol and the clinical or clinical-laboratory test (study) report for the medical device.
4. Testimonials from medical organisations on experience with the use of a medical device, without the provision of clinical data on the medical device in accordance with international requirements, shall not be recognised as evidence of the efficacy and safety of the medical device.
5. Clinical data on a medical device obtained from clinical tests (studies) or from the use of the medical device in states that are not members of the Union may be presented in the clinical evidence report on the efficacy and safety of the medical device to prove efficacy and safety where such data confirm the efficacy and safety of the medical device for the indications for medical use in accordance with the intended use of the medical device. Clinical data on a medical device obtained from clinical tests (studies) conducted in states that are not members of the Union, submitted by the applicant in the clinical evidence report on the efficacy and safety of the medical device, shall be recognised by the competent authority (expert organisation) as a source of clinical data on the medical device where one of the following conditions is met:
(a) the clinical data are confirmed by publications in specialised journals or by World Health Organization reports under the WHO prequalification project, published on the World Health Organization website on the Internet.
Specialised journals include any international-level journals specialising in the field of medical application of the medical device being registered, as well as publications on international web resources and health databases (e.g., Medscape, Medline, PubMed, New England Journal of Medicine). Publications shall relate to the medical device being registered and shall enable its evaluation. Providing publications on the technology of medical device use (e.g., on stenting procedures, radiological therapy, etc.) instead of publications on the evaluation of a specific medical device being registered is not acceptable;
(b) results of clinical tests (studies) of the medical device conducted in accordance with the recommendations of the International Medical Device Regulators Forum (IMDRF) are provided. The clinical tests (studies) conducted shall be verifiable as meeting international requirements.
6. Clinical data on another medical device may be accepted by the competent authority (expert organisation) as evidence of the efficacy and safety of the medical device being registered only where the applicant provides evidence of its equivalence to the medical device being registered by simultaneously fulfilling the following conditions:
(a) the medical devices under consideration have the same intended use;
(b) the technical and biological characteristics of the medical devices under consideration are identical to the extent that guarantees the absence of differences in their clinical efficacy and safety.
7. The equivalent medical device whose clinical data are used to substantiate the clinical safety and efficacy of the medical device being registered need not be registered in the EAEU Member States (hereinafter — Member State). In this case, a copy of the registration certificate (free sale certificate, export certificate) issued in the manufacturer's country shall be provided for such equivalent medical device, with a translation into Russian.
The requirements for the scope and level of detail of clinical data obtained for equivalent medical devices are the same as those for clinical data on the medical device being registered.
8. Clinical data on a medical device equivalent to the medical device being registered shall conform to the requirements for clinical data on a medical device established within the Union.
9. Clinical data on a medical device equivalent to the medical device being registered, obtained from clinical tests (studies) conducted in states that are not members of the Union, shall meet the requirements established in Section II of this document.
10. The justification of the clinical efficacy and safety of medical devices of potential risk classes 3, 2b and implantable medical devices shall be based on clinical data on the medical device obtained from multicentre clinical tests (studies).
Results of clinical tests (studies) that were completed before 1 January 2016 (as of the date of the last visit of the last patient or test (study) subject) or were ongoing as of 1 January 2016 (with completed patient enrolment) on the territory of a Member State may be accepted for consideration by the competent authority (expert organisation) provided that such clinical tests (studies) were conducted in accordance with the legislation of that Member State. In this case, the medical organisations in which the clinical tests (studies) were conducted shall meet the requirements of the legislation of the Member State on whose territory the clinical tests (studies) were conducted, and need not necessarily be included in the unified register of authorised organisations entitled to conduct research (testing) of medical devices for registration purposes. The results of such clinical tests (studies) shall be documented in a clinical test (study) report for the medical device in accordance with the legislation of the Member State on whose territory they were conducted, and shall be approved by the coordinating investigator.
Results of clinical tests (studies) that were completed before 1 January 2016 (as of the date of the last visit of the last patient or test (study) subject) or were ongoing as of 1 January 2016 (with completed patient enrolment) on the territories of states that are not members of the Union may be accepted for consideration by the competent authority (expert organisation) provided that such clinical tests (studies) were conducted in accordance with the recommendations of the International Medical Device Regulators Forum (IMDRF) and approved by the coordinating investigator.
Results of clinical tests (studies) initiated after 1 January 2016 may be accepted for consideration by the competent authority (expert organisation) provided that the clinical tests (studies) were conducted in accordance with the Rules for Conducting Clinical and Clinical-Laboratory Tests (Studies) of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission of 12 February 2016 No. 29, and at least one of the clinical tests (studies) was conducted in one of the Member States.
11. For medical devices of potential risk classes 3, 2b and implantable medical devices, the clinical evidence report on the efficacy and safety of the medical device shall include a post-registration clinical monitoring plan in accordance with the Rules for Conducting Safety, Quality and Efficacy Monitoring of Medical Devices, approved by Decision of the Board of the Eurasian Economic Commission of 22 December 2015 No. 174 (hereinafter — the Monitoring Rules).
The post-registration clinical monitoring plan shall contain the information and data established in paragraph 21 of the Monitoring Rules.
The post-registration clinical monitoring plan shall also indicate the timelines for its implementation. Post-registration clinical monitoring reports on the safety and efficacy of medical devices submitted in accordance with the Monitoring Rules shall be assessed by the competent authority (expert organisation) also for their conformity with the post-registration clinical monitoring plan. Where necessary, amendments may be introduced to the post-registration clinical monitoring plan as part of updating the data contained in the registration dossier.
12. In respect of in vitro diagnostic medical devices, the following shall not be mandatory:
conducting multicentre clinical-laboratory tests (studies);
where multicentre clinical-laboratory tests (studies) are conducted — conducting them in one of the Member States.
The manufacturer shall have the right to conduct multicentre clinical-laboratory tests (studies) of in vitro diagnostic medical devices.
13. To prove the efficacy and safety of in vitro diagnostic medical devices of potential risk classes 2b and 3, it is sufficient to conduct clinical-laboratory tests (studies) at one medical organisation.