Clinical trials of medical devices

Clinical trials of medical devices

Clinical trials of medical devices are obligatory trials required for successful registration of the devices. These trials confirm the possibility of use of the medical device for the medical purposes.

Clinical trials usually follow the results of technical trials and toxicology research. They are the most important for the registration authority to make a decision on registration of the medical device.

If the results of clinical trials are not successful, you should start registration from the very beginning in most cases. It means significant additional time and money losses for registration for the manufacturer.

Forms of trials

Clinical trials can be performed in the following ways according to the type of the medical device and the available clinical data:

  • form of analysis and evaluation of the available information;
  • form of testing with participation of a human;
  • form of clinical laboratory testing.

Clinical trials as analysis and evaluation of available information

This is the easiest and the quickest way to test the medical device. The most clinical trials in the Russian Federation are currently performed in this very form. It requires only to collect clinical data for the medical device (as a rule, for foreign-made devices that are already in trade on other countries’ markets) or for the similar device that has already been registered in the Russian Federation (for Russia-made devices).

On the basis of the available clinical data, the registration body performs evaluation and analysis of quality, safety and efficiency of the device to be registered. Then the body makes a conclusion on possibility to use the device for medical purposes.

Clinical trials as testing with participation of a human

This is the most expensive and the longest way. It requires a significant amount of money and time to be performed. In some cases, for example, in case of trials of implants, the terms can be prolonged for years due to lack of patients that comply with the criteria of trial participation. However, nowadays, in most cases, there is no need to perform trials with participation of a human.

Clinical trials as clinical laboratory testing

These trials are performed for the medical devices for in vitro diagnostics. The applicable laws presume for them the only way of trials.

Trials are performed with use of samples of the patients’ biological material taken during treatment and diagnosis process, or with use of museum test strains from state, national, research or other collections of pathogenic microorganisms (for new infection diseases or rare zoonotic infection diseases). It allows to evaluate the devices quality, efficiency and safety as precise as possible.

In which cases clinical trials with participation of a human are required

Article 37 of the Order of the Ministry of Healthcare of the Russian Federation dated the 9th of January, 2014, N 2n «On acceptance of the order of evaluation of compliance of the medical devices in form of technical trials, toxicology researches, clinical trials for state registration of these medical devices» (hereinafter ‒ Order 2n) establishes the following cases that require trials with participation of a human:

  • the medical device to be registered belongs to a new type according to the nomenclature classification;

  • the medical device to be registered features new complicated and/or unique and/or special methods of prevention, diagnosis and treatment of illnesses and conditions, or new complicated medical technologies are used;
  • in case when the analysis and estimation of clinical data haven’t approved the medical device efficiency and safety.

In all the other cases, clinical trials are performed as analysis and evaluation of the available clinical data.

Required documents

According to article 38 of Order 2n, clinical trials of medical devices (except for the devices for in vitro diagnosis) according to the national rules of the Russian Federation require submitting of the following documents to the medical authority:

  • application letter on performing of clinical trials;
  • samples (a sample) of the medical device (except for the medical devices mounting (commissioning) of which requires a letter of permission (a license), creation of special conditions, building of separate fundamental structures and additional training of the personnel, and, in some cases, visit to the organization where the medical device is located and (or) allowed for use according to the laws of the country to be visited);
  • allowance to perform clinical trials issued by the Federal Service for Surveillance in Healthcare;
  • act of evaluation of the results of technical trials of the medical device with application of the documents that confirm the results of technical trials;
  • conclusion based on the results of toxicology researches of the medical device with application of the documents that confirm the results of toxicology researches (for the devices use of which presumes contact with the human’s organism);
  • results of testing for approval of the pattern of measuring devices (for the medical devices that belong to the measuring devices in the field of state regulation of unification of measurements, the list of which is determined by the Ministry of Healthcare of the Russian Federation);
  • information on the regulating documentation for the medical device with a list of national (international) standards that establish the requirements the device complies with (when it is used by the manufacturer);
  • the manufacturer’s technical and operational documentation for the medical device;
  • photographic image of the general view of the medical device with the accessories required for intended use (of size being at least 18 x 24 cm);
  • documents (materials) containing information on clinical use of the medical device, including the use outside the Russian Federation, including the reviews, the reports on performed scientific researches, the publications, the information reports, the analysis of risk of use, the methods of use (when available).

For the medical devices for in vitro diagnosis, submit the following documents (according to article 48 of Order 2n):

  • application letter on performing of clinical trials of medical devices for in vitro diagnosis;
  • samples (a sample) of the medical device for in vitro diagnosis with the accessories (equipment, set of chemical agents, calibration devices, reagents, test systems, control materials, measuring and verification devices, nutritional media) required for intended use;
  • act of evaluation of the results of technical trials of the medical device for in vitro diagnosis with the accessories (equipment, sets of chemical agents, calibration devices, reagents, test systems, control materials, measuring and verification devices, nutritional media);
  • operational documentation for the medical device for in vitro diagnosis with the accessories (equipment, sets of chemical agents, calibration devices, reagents, test systems, control materials, measuring and verification devices, nutritional media) required for intended use (when needed);
  • documents (materials) containing analysis of information on use of the medical device for in vitro diagnosis (when available);
  • results of testing for approval of the pattern of measuring devices (for the medical devices for in vitro diagnosis that belong to the measuring devices in the field of state regulation of unification of measurements, the list of which is determined by the Ministry of Healthcare of the Russian Federation).

Where to perform clinical trials

The trials can be performed only in the medical organizations that comply with the requirements of the Order of the Ministry of Healthcare of Russia dated 16.05.2013 No. 300n «On acceptance of the requirements to medical organizations that perform clinical trials of medical devices and the procedure of approval of compliance of the medical organization with these requirements».

The valid list of the organizations that comply with the requirements of this order is placed on the web-site of the Federal Service for Surveillance in Healthcare.

This digital Service contains information on:

  • date of registration of the organization in the List;
  • name and legal entity type of the medical organization;
  • contacts (phone number, fax, e-mail address).

Simple search mechanism allows to find the organization by its name, and extended search mechanism allows to find it by the date of registration in the List.

When choosing the medical organization to perform clinical trials, consider the list of its works (services) according to the license. For example, you can not test a gynecological examination chair in a medical organization which license does not cover the field of gynecology. In case when clinical trials are performed in an organization without the corresponding branch of licensing, the Federal Service for Surveillance in Healthcare can not accept the results. It can lead to denial of the device registration.

Terms of performance

The terms depend directly on the chosen form. For trials in form of analysis and evaluation of available information, the given period of testing, as a rule, does not exceed 1 month.

In case when clinical trials with participation of a human are required, the terms are determined by the type of the device to be tested. Trials of diagnosis devices for general purposes (ultrasonography apparatuses, tonometers, densitometers) can be performed within 3-4 months, but trials of implants (fillers, stents, cardiac valve prostheses) can take from a year to several years.

At the same time, you should consider that clinical trials with participation of a human are allowed to be performed only according to those aspects of use of the medical device to be registered that are not supported by a significant amount of clinical data. Thus, if you possess at least a part of clinical data, the scope and the terms of trials with participation of a human can be significantly reduced.

The terms of performance of clinical laboratory trials (for the devices for in vitro diagnosis), as a rule, is from 1,5 up to 4 months. However, in case when the trials require samples of rare pathologies (for example, during trials of reagents and their sets for diagnosis or rare genetic diseases) the terms can increase to 6-8 months.

Long-term work experience in the field of performance of clinical trials and registration of medical devices allows us to select the most practicable form of trials and to reduce their terms to the minimum.

Price of clinical trials

To calculate the price, you need to submit the developed documents of the registration dossier for your medical device.

The price of clinical trials depends first on the following parameters of the medical device:

  • risk class;
  • matter of use;
  • innovation degree;
  • presence of registered analogous devices;
  • presence of clinical data (results of pre-clinical trials, clinical reports, scientific publications, comments of medicine doctors, etc.).

Besides, the price depends on the form of trials: in the form of analysis and evaluation of the available information (without participation of a human), in the form of testing (research) with participation of a human, in the form of clinical laboratory trials (for the devices for in vitro diagnosis).

Thus, the price of works can be calculated after the precise estimation of the available documents included into the registration dossier.

Why to choose us?

The specialists of the company KC-PROF have been working in the field of registration of medical devices since 2014. We have accumulated a large experience both in registration and in organizing of clinical trials.

The company experts have a successful experience of organizing and performance of multi-center clinical trials with participation of a human for the devices of the 3 risk class, including the ones according to the requirements of the European Union.

The long-term partnership with the leading medical centers included into the register of the bodies authorized to perform clinical trials assure the possibility to offer you a reasonable price of works and to exclude delays during testing and issuance of the results.

We are ready not only to provide the services for performance of clinical trials, but also to solve any other questions regarding receiving of the registration certificate. When required, we timely correct the documents of the registration dossier according to the recommendations of the medical authorities given during trials.

For conclusion

Performance of clinical trials of medical devices is a vividly important step of the registration process. This very step determines practicability of use of the device in the medical field.

During trials, the medical personnel, on the basis of their work experience, knowledge and the device documentation submitted, make a conclusion about correlation between the potential usefulness and possible hazard imposed by use of the medical device to be registered.

The company KC-PROF, with full understanding of importance of the clinical trials stage, is ready to offer the complete medical trials in the authorized medical centers that have been our cooperative partners for many years. We will select the appropriate form of trials, reduce to the minimum the amount of samples of the medical devices to be registered that are to be submitted and provide receiving of the test results as soon as possible at the reasonable cost.

You may contact us in any convenient way to get a free primary consultation.

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