How testing should be provided according to 2n

Order of the Ministry of Health of the Russian Federation (Minzdrav Rossii) dated 9 January, 2014 No. 2n “On Approval of the Procedure for Conformity Assessment for Medical Devices in the Form of Technical Testing, Toxicology Testing and Clinical Trials Performed for the Purpose of Marketing Autorisation of Medical Devices” (full text here).

This procedure defines the requirements for conformity assessment of medical devices performed as part of marketing authorisation, and lists the necessary documents to be submitted to the relevant state authorities. There are several types of testing, namely technical testing, toxicology testing and clinical testing (trials), and each include conformity assessment of medical devices in general and specific conformity assessment of medical devices intended for in vivo diagnostics.

It is important to note that all documentation provided to the testing authority shall be drawn up in Russian. Testing deliverables include related statements (please refer to appendiхes 1–5 to this Order).

            The duration of technical testing depends on the intended use and complexity of the medical devices tested, the completeness and quality of the documentation provided, but in any circumstance it may not last longer that thirty (30) days.

The duration of the assessment performed in the form of toxicology testing depends on the intended use and complexity of the medical devices concerned, the type and duration of contact with the human body, the completeness and quality of the documentation provided, but in any circumstance it may not last longer that thirty (30) days.

In certain cases, the duration of the tests, both technical and toxicological, may be increased to up to 20 business days, provided such increase is agreed with the applicant.

the duration of clinical testing or trials depends on the intended use and complexity of the medical devices tested, and on the completeness and quality of the documentation provided. The exact duration of the clinical testing has to be determined by the clinical testing committee upon review of the documentation provided.

            Let us look in detail at certain variants of the testing concerned.

Technical testing may be performed in the form of data review and analysis only when the medical devices involved do not require any specific conditions for being commissioned, such as the erection of stand-alone buildings, extra staff training or, sometimes, an on-site visit to the manufacturer.

Review and analysis means working with the technical literature and information containing safety related data, performance data and specifications, completed test results and analysis of manufacturing conditions. If such review and analysis could not confirm the safety and efficiency of the medical device, then tests have to be conducted.

Technical testing of medical devices intended for in vitro diagnostics include conformity assessment for devices, equipment, reagent kits, reagents, chemicals, test systems (assays), controls, calibrators and nutrition media. Self-contained analytical systems with accessories (such as reagent kits and calibrators necessary for operation of the medical device) may be tested together within one testing protocol.

This evaluation includes analysis of the available technical and scientific literature data related to the safety, efficiency, and functionality of the device, a review of the technical and operational documentation of the manufacturer, and a review of the test results conducted for the medical device concerned for in vitro diagnostics.

The goal of technical testing is to assess compliance with the requirements of international standards and regulations, and the technical and operational documentation of the manufacturer; the completeness and integrity of the parameters set forth in the specification as subject to control under technical testing; the quality and safety of the medical device's usage.

Toxicology tests are to be conducted for medical devices intended for contact with the human body; these involve assessment of the physical and chemical, sanitary and chemical and biological action both in vitro and in vivo.

It is worth noting that single usage sterile items have to be tested for sterility, and related validation methods have also to be assessed. Medical devices intended for contact with the blood and its components, as well as with the substances intended for infusions and injections, have to be tested for pyrogenicity and for blood compatibility.

The goal of toxicology testing is to assess compliance with the requirements of international standards and regulations, and the technical and operational documentation of the manufacturer; the completeness and integrity of the parameters set forth in the specification as subject to control under technical testing; the quality and safety of the medical device's usage.

Clinical testing could be performed in the form of a clinical data review and assessment, as well as in the form of trials involving human subjects.

Human subject participation is necessary in the event of marketing authorisation of a new type of medical device, the usage of new, unique or sophisticated specific methods of prevention, diagnostics and treatment of diseases and conditions, as well as of sophisticated and complex medical techniques.

Clinical testing of medical devices for in vitro diagnostics is performed in the laboratory settings using biological samples of the patients obtained as part of diagnostic and treatment protocols. Testing of medical devices intended for in vitro diagnostics of new infectious diseases or rare diseases has to be performed using archive test strains from state, national, research or other collections of pathogenic micro-organisms.

The goal of clinical testing is to assess compliance with the applicable regulations, technical and operational documentation of the manufacturer; the completeness and integrity of the parameters of the medical device set forth in the regulative, technical and operational documentation; the quality of the medical device, the efficiency and safety of its usage, including the expected therapy effect of the medical devices used for therapeutic purposes.

As for medical devices for in vitro diagnostics, the sensitivity, specificity and reproducibility of the results stated in the technical and operational devices must also be checked.