Software as a Medical Device (SaMD), in other terms – «software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device» (according to the definition of U.S. Food & Drug Administration), is rather new term in the field of Medical Device state registration in Russia. There are a lot of questions about specifics of its registration, requirements and amount of documentation, with lack of adequate information or fully available legal acts. Today we want to tell about the necessity of carrying out the biocompatibility (toxicological) trials for SaMD, delivered on USB-flash drive or CD-disk.
Nowadays one of the most important legal aсts about trials of medical devices concerning the process of medical device registration in Russia – Order of Ministry of HealthCare №2n from 9 of January 2014. It is named «The procedure of conducting of conformance evaluation of medical devices in the form of technical trials, biocompatibility trials, clinical trials for the purpose of state registration of medical devices».
According to the text of this Order, article 25,
Biocompatibility trials of medical device are carried out for the device in contact with the human body when used in accordance with the intended use, prescribed in the manufacturer’s documentation:
a) medical device and (or) accessories of medical device, contacting the surface of the human body;
b) medical device temporarily injected into the human body from the outside;
c) medical device implanted in the human body.
Our Company decided to ask Roszdravnadzor about specifics and applicability of these requirements to the SaMD, that is delivered on the USB-flash drive or CD-disk, in the form of information request letter *, during the process of preparing of registration dossier of 3D imaging software to improve the planning and workflow of endodontic procedures, provided on the USB-flash drive. The peculiarity of delivery method is – after Software installation USB-flash drive or CD-disk does not contact with operator or patient. So, according to the text of article 25, «…when used in accordance with the intended use…», the physical delivery device (USB-flash drive or CD), that is used before the intended use applications, should not pass through biocompatibility trials.
The official answer from Roszdravnadzor confirmed, that realization of biocompatibility trials of the USB-flash drive or CD-disk is not required in this situation, with reference to the 25 article of Order №2n. Here we would like to mention, that the judicial value of these answers is almost equal to zero, for example, you can not use the answer as argument during the official complaint process with Roszdravnadzor. It is rather points to ponder.
* according to the terms of Federal Law №59-FZ from 2 of May 2006, regulating the procedure of consideration of Russian Federation citizens (including legal persons) petitions.