Testing of a medical device for the purposes of marketing authorisation, particularly on-site visits as one of the testing methods.

Marketing authorisation of medical devices consists of several steps, one of which is testing.

Testing could be of three types, namely:

• Toxicology testing,
• Technical testing, and
• Clinical testing (trials)

The procedure for the testing mentioned above is set forth in the 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 Approval of the Medical Devices” (Hereinafter “No. 2n”).

Toxicology testing is performed in order to confirm the safety of the materials constituting the medical device which are in contact with the human body, and involves the following parameter checks (for the purposes of this article, medical devices for in vitro diagnostics are not considered herein):

• physico-chemical properties;
• sanitary and chemical properties.

IMPORTANT! Toxicology testing has to be performed exclusively on the territory of the Russian Federation by qualified laboratories, since Order No. 2n does not assume any possibility for those laboratories to perform testing in countries other than the RF.

Samples for toxicology testing have to be provided in accordance with GOST 31214-2003 “Medical devices. Requirements for samples and documentation presented for toxicological tests, sanitary and chemical analyses, tests for sterility and pyrogenicity” (Appendix B).

For devices such as glucometers, various handles for equipment, blood heaters, patient monitors etc., samples containing various materials and dyes shall be provided. Should any single model include all materials and dyes used in other models concerned, then only this model may be provided for testing.

In the event that the equipment to be tested is large (e.g., a CT unit), then toxicology testing may be conducted only for the pieces of materials coming into immediate contact with the human body or tissues. Those samples may be imported to Russia without any permits issued by Roszdravnadzor.

IMPORTANT! The samples shall constitute literally pieces of the materials rather than a single sub-unit of the larger device, otherwise this sub-unit (e.g., a positioning device for patient support for radiotherapy) may be considered as a medical device in itself, therefore requiring an import permit issued by Roszdravnadzor.

Technical testing, unlike that for toxicology, may be conducted both in the form of testing itself, and in the form of data assessment and evaluation. However, the latter variant is applicable only when

• installation (or commissioning) of a device requires a permit (license),
• any specific conditions are required,
• any standalone buildings have to be erected,
• extra training for the staff is required,
• and sometimes, when a visit to the manufacturing site is required.

 

IMPORTANT! The high cost of the devices to be tested cannot justify technical testing in the form of an on-site visit.

Which devices are falling within the aforementioned conditions?

• PET\CT units
• MRI units
• CT units
• X-ray tubes, collimators, RF-coils (since those sub-devices are never used as stand-alone devices, without an X-ray unit or MRI equipment set, and they have to be tested as part of the related equipment sets)

An on-site visit may be used for verification of the following information:

1. a) review of the technical literature and/or information concerning safety, performance and specifications, as well as the intended use of the device in question;
2. b) review of the test results for the medical device concerned;
3. c) analysis of manufacturing process conditions of the medical device concerned

The on-site visit has to be performed by the representatives of the testing body jointly with the authorised representative of the manufacturer on the territory of the Russian Federation.

During the on-site visit, the following items are checked and verified: reports for compliance with the applicable international standards; manufacturing facilities, declared by the manufacturer and having an ISO 13485 certificate; samples provided in accordance with the application for marketing authorisation; product storage; and rejected products reports.

Upon completing the on-site inspection, the testing lab completes a technical testing report on the basis of the available manufacturer’s reports, and modifies it with the applicable local standards, if necessary.

Most of the devices are to be tested directly at the testing body on the territory of the Russian Federation. Before the start of the testing, it is necessary to provide the laboratory with the technical and operational documentation and deliver samples to the laboratory involved.

The amount or number of the samples has to be agreed in advance with the testing lab.

If the marketing authorisation application contains several variants of the device implementation (model line/family), usually the master model (that of the maximum configuration) has to be submitted for testing; however design differences and etc. also have to be considered, e.g., devices having a different electrical shock protection class have to be tested individually.

Clinical testing is usually performed in the form of a review of the available clinical data and its assessment, however, when the device concerned

• has no analogues (new device),
• or implies any new, unique or sophisticated technologies,
• or the available clinical data review or assessment failed to confirm the safety and efficiency of the medical device concerned,

then clinical testing has to be performed in the form of a regular clinical trial, using human subjects (in this case, approval is required from the Board of Ethics in the Field of Medical Device Circulation of the Ministry of Health of the Russian Federation, on the ethical feasibility of a trial involving human subjects).

The amount or number of samples has to be agreed with the testing body.

This type of testing is the only one for which the duration is not specified. The duration of testing in that case is determined by the complexity and intended use of the medical device concerned (for example, some clinical trials involving human subjects may last for decades).

So far in this article we have considered types of medical device testing, and illustrated, at certain levels of details, technical testing performed in the form of an on-site visit.