We are glad to inform that currently the tension on the medical devices market is supposed to go down, at least, for a while. Thanks to the EBA efforts the resolution of the issue related to the format of the conformity evaluation body number (number format), to be placed on medical devices, is now moved forward.
The EBA has been preoccupied with the issue for over half a year. Our requests to resolve the issue have been received by Ministry of Health of Ukraine (MOH), Ministry of Economic Development and Trade of Ukraine (Mineconomy) and the State Service on Medicines and Drugs Control (SMDC).
The current legislation has a gap as regards the rules to be used by the medical devices’ manufacturers when placing the number on their medical devices. The manufacturers used the numbers indicated in the agreements that the conformity evaluation bodies concluded with them, which was logical and reasonable.
In February 2017 the Mineconomy letter appeared on the website of the SMDC recommending to deem the only number format as a correct one. At that point of time medical devices marked differently were already in abundance in the market of Ukraine. Some companies were imposed with fines for “incorrect” marking.
The situation escalated to such an extent as preventing the distributors and pharmacies from sales of medical products and their further acceptance. Thus, a rather big part of the medical devices market was at hazard and could be fully stopped.
The EBA expresses its gratitude to the SMDC for instructing the territorial bodies as of 31 July 2017 not to impose fines based on the number format until the Mineconomy and MOH explanation is in place.
Currently, we assume that it brought a temporary relief for the market operators. However, we should remember that in case the Mineconomy and MOH official explanation and necessary amendments to the current legislation are much delayed the negative impact may come back as a threat for Ukrainian patients who will find out that the necessary medical devices are unavailable.
We hope the Mineconomy and MOH official explanation will be issued soon bringing a final stop to the market tension while the already developed amendments to the legislation will be finally adopted to remove the ambiguous situation.
Taking this opportunity, we inform that on 27 July 2017 Mineconomy web-published the draft amendments to the Сabinet of Ministries Resolution No.1184 dated 30 December 2015 for public discussion purposes. The necessary amendments to the Mineconomy Order No.224 dated 10 February 2016 are also developed. Adoption of both drafts shall bring legitimacy to marking medical devices with both number formats.