Exception From the Rule: Circulation of Medical Devices that Fall Short of Technical Regulations

On 22.07.2015 the Ministry of Health of Ukraine published the draft order of the Cabinet of Ministers of Ukraine «About adaptation of Order of introduction into circulation and/or exploitation of medical devices that fall short of technical regulations, but the use of which is necessary for healthcare protection interests and life of certain person» on its website for public discussion.

It is set by the effective technical regulations that the medical devices shall go through the procedure, requested for being marked with a national sign of conformity.

At the same time, these technical regulations make an exception from the noted rule. Even in case of disparity to the requirements of technical regulations, medical devices can be approved for circulation and exploitation in case their use is a necessity for the healthcare protection interests and life of a certain person.

In particular, according to the Draft’s authors view the exhaustive list of the following grounds will serve as the proper grounds for the positive decision regarding circulation and exploitation of such medical devices:

1. participation in the programs of technical assistance or international cooperation in accordance with international agreements;
2. natural calamity, failure, epidemics, technogenic ecocatastrophes, leadthroughs of anti-terror operation, introduction of the military, extraordinary state;
3. independent consumption by a concrete person with the purpose of maintainance of its life and health.

For the receipt of permission on the circulation and exploitation of medical devices one shall submit an application of stated form and exhaustive list of accompanying documents, which are set by the Draft depending on the ground why the use of such device is necessary to the State Services of Ukraine on Medical products.

However, the application can be dismissed in case of confirmation of risks resulted from such medical devices. Thus dangerous character of these products can be confirmed by the following sources:

1. international, regional and foreign report systems about products which cause a serious risk (p 3 of the Order of development and revision of sectoral plans of market supervision, monitoring and accounting about their implementation, ratified by the Cabinet of Ministers of Ukraine on 26.12.2011. № 1410);
2. information from producers or authorized representatives about medical devices.

It shall be noticed that Draft offers an operative procedure of decision-making regarding permission of circulation and exploitation of stated medical devices. In particular, according to the Draft the maximum term to adopt such a decision is up to five business days.