According to the Government of the Russian Federation decree dated 27 December 2012 No. 1416 “On the approval of the rules state registration of medical devices” the term “technical testing” is defined as the testing to determine whether the characteristics (properties) of the medical device meet the requirements of the regulatory, technical and operational documentation of the producer (manufacturer) and making a subsequent decision on the possibility of conducting clinical testing. However, medical devices for in vitro diagnostics are not required any decision regarding clinical testing. Therefore the concept of testing comes down only to the first part of the definition.

Technical testing of medical devices for in vitro diagnostics is regulated by such regulatory document as The Order of the Ministry of Health of the Russian Federation 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 Authorization of Medical Devices”.

Technical testing can only be carried out in accredited and recognized independent in the manner prescribed by law testing centers (laboratories) [3]. The term of the testing does not exceed 30 working days from the date of the providing of all necessary documents, samples, medical device and equipment. If necessary, and as agreed with the applicant, this period may be extended but not more than 20 working days.

The list of the documents which have to be submitted to the testing center for conducting technical testing listed in [2].

Medical devices for in vitro diagnostics include various devices, equipment, reagent kits, reagents, test systems, control materials, calibrators and growth medium. For this category of products, technical testing is carried out in order to verify the quality and safety of the medical device for in vitro diagnostics when it is used in accordance to designation provided in manufacturer’s documentation. If technical testing is carried out for a device with accessories, sets of reagents and calibrators, which are a closed analytical system, then these measures can be carried out as part of a single technical testing.

During technical testing for medical devices for in vitro diagnostics the following actions are carried out:

– medical device identification;

– determination and coordination of the type and potential risk class of medical device;

– analysis of the manufacturer’s technical documentation for the medical device;

– drawing up the program and methodology of technical testing;

– conducting of the technical testing of the presented samples of  medical device for in vitro diagnostics in order to confirm such functional characteristics as analytical sensitivity, specificity, reproducibility, linearity, etc .;

– evaluation and analysis of data related to the medical device to verify its quality and safety;

– completion of  manufacturer’s technical and operational documentation according to the testing results (if necessary).

The results of technical testing of medical devices for in vitro diagnostics are considered positive and confirm the quality and safety of the medical devices for in vitro diagnostics, except of the following cases:

– the submitted samples of the medical device for in vitro diagnostics together with accessories do not meet the requirements of regulatory documents, manufacturer’s technical and operational documentation;

– special equipment developed by the manufacturer for the technical testing of a specific medical device for in vitro diagnostics and indicated in the technical documentation does not provide the ability to carry out the necessary technical testing.

At the end of the technical testing, an act is issued to evaluate the results of the technical testing of the medical device for in vitro diagnostics, which is submitted as a part of the registration dossier.

Bibliography

1. Government of the Russian Federation decree dated 27 December 2012 No. 1416 “On the approval of the rules state registration of medical devices”
2. The Order of the Ministry of Health of the Russian Federation 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 Authorization of Medical Devices”.
3. GOST R 51352-2013 Medical devices for in vitro diagnostics. Test methods.