Ability of conducting clinical testing. But, medical devices for in vitro diagnostics aren’t required any choice regarding clinical testing. Therefore, the notion of testing comes down just into the first portion of the definition. Technical testing of medical devices for in vitro Diagnostics is governed by such regulatory record as The Order of the Ministry of Health of the Russian Federation dated 9 January, 2014 No. 2nOn Approval of the Procedure for Conformity Assessment for Medical Devices in the kind of Technical Testing, Toxicology Testing and Clinical Trials Performed for the use of Marketing Authorization of Medical Devices. Technical testing may only be carried out in licensed and recognized separate in the way prescribed by legislation testing centers. The term of this testing doesn’t exceed 30 working days from the date of the providing of all necessary documents, samples, medical apparatus and equipment. If necessary, and as agreed with the applicant, this period could be extended but not more than 20 working days.
The list of the files which have to be submitted to the testing centre for conducting technical testing recorded in. The medical device testing for in vitro diagnostics include various Apparatus, equipment, reagent kits, reagents, test systems, control materials, calibrators and growth medium. For this category of goods, technical testing is performed so as to confirm the quality and security of their medical device for in vitro diagnostics if it is used in accordance with designation provided in manufacturer’s documentation. If technical testing is completed for a device with attachments, sets of reagents and calibrators, which can be a closed analytical system, then these steps can be carried out within one technical testing. During technical testing for medical devices for in vitro Diagnostics these actions are completed:
- Medical device identification
- Determination and coordination of this type and Possible hazard class of medical device
- Evaluation of the manufacturer’s technical documentation for the medical device
- Drawing up the methodology and program of specialized testing
- Running of the technical testing of the introduced Samples of medical apparatus for in vitro diagnostics to be able to confirm such operational characteristics as analytical sensitivity, specificity, reproducibility, linearity, etc.
- Analysis and analysis of data about the medical Device to confirm its quality and security conclusion of manufacturer’s technical and Operational documentation based on the testing results.
The results of specialized testing of medical devices for In vitro diagnostics are considered favorable and confirm the quality and security of their medical devices for in vitro diagnostics, except of the following instances. The submitted samples of this medical device for in Vitro diagnostics together with attachments don’t meet the needs of regulatory documents, producer’s technical and operational documentation.