EAEU: Adopted criteria for the inclusion of different versions of a modified medical product into one registration certificate
The adopted Decision establishes that it is possible to include several versions of a modified medical product belonging to one type of medical device into one registration certificate in accordance with the nomenclature of medical products used in the EAEU provided that these modifications comply with the following criteria:
- modifications of the medical product have been carried out by the same manufacturer of this medical product and according to the same technical documentation;
- all versions of the modified medical device belong to one class of potential use risk;
- there a presence and/ or quantitative content of the same clinically (diagnostically) significant analyte(s) in a biological sample (for medical devices for in vitro diagnostics);
- versions of the medical device have different configurations that do not affect the principle of operation and the functional purpose of the device, which allows for the expansion of their use or their special use for medical purposes (as applicable);
- versions of the medical device have various technical parameters (for example, radiation wavelength, size of the light field, resolution, etc.) that do not affect the principle of its operation and functional purpose (as applicable);
- versions of the medical device are forming a standard product range (for example, have different sizes (overall, linear, volumetric, etc.), shape, colour coding, etc.) or are a group of the medical device (for example, a stationary mobile device (device, system, complex, etc.) with wall and (or) floor mounting, etc.) (as applicable). In this case, the group of the medical device is the product for which one group drawing of parts and (or) one group specification have been made.
Law: Decision No. 123 of 24 July 2018 on the Criteria for Inclusion of Several Medical Product Versions Related to One Type of Medical Products in Accordance with the EAEU Medical Device Nomenclature