Note: This article does not apply to in vitro testing of medical devices for diagnostics, as in this case field trials (trials on the spot or so called factory audit for testing) are not applicable.

Introduction

Tests conducted for the purposes of the state registration of medical devices are regulated by Order No. 2n dated 09 January 2014 “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 the Marketing Authorisation of Medical Devices.”

            According to the text of this order, a visit to the place of production is possible only for the purpose of technical tests of the medical device (including tests for electromagnetic compatibility),

“Technical tests in the form of data assessment and analysis are conducted only for medical devices the commissioning of which requires permits (licenses), special conditions, construction of certain capital facilities and additional training of specialists, and in some cases an on-site visit to the place of manufacture of a medical device)”

Order No. 2n dated 01-09-14

during which the following is carried out:

“a) analysis of the technical literature data and information related to safety, operational and technical characteristics, as well as the intended use of the medical device;

1. b) review of the test results for the medical device concerned;
2. c) analysis of the manufacturing process conditions of the medical device concerned”.

Order No. 2n dated 01-09-14

Field technical tests are possible, for example, for an MRI scanner, a CT scanner or individual components of large equipment, such as an x-ray emitter or a collimator for x-ray machines.

What is required for field trials?

So, by the time field trials are carried out the technical (technical document) and operational (operating manual) documentation should be ready, the test reports on testing for applicable international standards with a harmonized Russian version, as well as an accredited laboratory, the staff of which will go to the site (places, if there are several production sites) of the medical device manufacture. Also, before departure it is necessary to coordinate with the laboratory a list of samples that will be necessary for the audit.

Audit procedures

In most cases, two laboratory staff are sent to the place of manufacture of a medical device: one to conduct technical tests and the other to conduct electromagnetic compatibility tests.

Field tests, in agreement with the host country, are usually conducted within three days.

Audit Results

Based on the results of field technical tests, the laboratory provides the results, drawn up in the form of an act and protocol. The protocol is not different from the usual protocol, and the act has two features:

– it states that, in addition to samples and the technical and operational documentation, the manufacturer has provided test reports on the applicable international standards that have harmonized Russian versions.

– it is separately indicated that the test site was a manufacturing site, with an address indicated.

Our company has consistently successful experience in conducting field trials and the subsequent registration of medical devices.

Note:

In the course of work on this article, the following guidance documents were used:

1. Order No. 2n, dated 09 January 2014 “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 the Marketing Authorisation of Medical Devices”.

https://rg.ru/2014/04/23/minzdrav-dok.html

2. GOST ISO/IEC 17025-2019 General requirements for the competence of testing and calibration laboratories

http://docs.cntd.ru/document/1200166732