The market is waiting for final solving of the problem with stamps for medical devices

14/ 07/ 2017

The problem with the uncertainty regarding the format of the number of authority that has evaluated the compliance of the medical product (OO) has been in place for a long time. The lack of clear rules in the legislation, on the one hand, and the lack of timely clarifications by public authorities, on the other hand, led to the fact that manufacturers used the well-known European rules for the issue of OIV numbers for their products. Of course, the OOPs, in which the medical product was evaluated, of course, also confirmed the correctness of the format of the number - OOPs are concluded with the manufacturers of the transaction, in which this number is indicated. One was not known in the market for sure whether the format of the numbering would later be considered correct by the state authorities who would check medical products on the market. On February 9, 2017, the Ministry of Economic Development and Trade explanation, which, unfortunately, has led to an increase in uncertainty in this issue. Clarification recognized the correct full format of the OOO number, which, for the most part, manufacturers did not apply to their products. At that time, the market for medical products was already filled with products, which contained an OO number in another, shortened format. The European Business Association has repeatedly warned about possible consequences for the market - blocking products - and asked to solve this problem. The need for its solution was also supported by the Public Council under the State Service of Civil Service of Ukraine, and an appropriate appeal was sent. The solution to the problem in essence depended on the joint decisions and interaction of the three state bodies: the Ministry of Economic Development, the Ministry of Health of Ukraine, the State Service of Internal Affairs of Ukraine. We must note that at this point in time, the issue has really advanced. Amendments to the Ministerial Decree No. 224 * were drafted, which are agreed upon between the three bodies and are awaiting approval. However, until the changes have not yet been adopted and the issue, respectively, is not regulated by law - the market tension is increasing. There are cases of blocking and imposing fines on manufacturers through the format of the OOP number and the requirements for the withdrawal of quality products. Trading networks send signals about the possible refusal to accept medical products through inappropriate labeling. That is, the problem not only led to excessive costs and complications of the activities of producers. It continues to contain the risk of further suspension of the relevant medical products and to be a reason for the potential imposition of fines. Therefore, the European Business Association appeals to the Ministry of Economic Development and Trade to ensure that amendments to the Order No. 244 are adopted as soon as possible. At the same time, we appealed to the Ministry of Health of Ukraine with a request to explain the legitimacy of the format of the OOO number in the market. We believe that such an explanation from the Ministry of Health of Ukraine, which is the body of technical regulation in the field of quality control and implementation of medical products, will allow now and in the future to suspend the circulation of quality medical products for the above-mentioned reasons during the implementation of state market surveillance. Additionally, we draw attention to the fact that the fact that the above problem has nothing to do with the quality of medical products is quite understandable. Products are already certified in the country of production; for the most part, has a CE mark, and, accordingly, was subsequently certified in Ukraine. Obviously, the problem is of a purely technical nature and consists in the lack of transparent rules that are timely reported to the market. Nevertheless, unfortunately, it has already become a major obstacle to the flow of medical products. So, it is expedient to accelerate its final decision. * The Order of the Ministry of Economic Development and Trade of Ukraine On Approval of the Procedure for the Establishment and Maintenance of the Register of Designated Bodies for the Evaluation of Conformity and Recognized Independent Organizations and the Procedure for the Establishment and Maintenance of Databases Obtained by the Appointing Authority from Designated Bodies of Conformity Assessment No. 244 of 10 February 2016

One was not known in the market for sure whether the format of the numbering would later be considered correct by the state authorities who would check medical products on the market.

On February 9, 2017, the Ministry of Economic Development and Trade explanation, which, unfortunately, has led to an increase in uncertainty in this issue. Clarification “recognized” the correct full format of the OOO number, which, for the most part, manufacturers did not apply to their products. At that time, the market for medical products was already filled with products, which contained an OO number in another, shortened format.

The European Business Association has repeatedly warned about possible consequences for the market – blocking products – and asked to solve this problem. The need for its solution was also supported by the Public Council under the State Service of Civil Service of Ukraine, and an appropriate appeal was sent.

The solution to the problem in essence depended on the joint decisions and interaction of the three state bodies: the Ministry of Economic Development, the Ministry of Health of Ukraine, the State Service of Internal Affairs of Ukraine. We must note that at this point in time, the issue has really advanced. Amendments to the Ministerial Decree No. 224 * were drafted, which are agreed upon between the three bodies and are awaiting approval.

However, until the changes have not yet been adopted and the issue, respectively, is not regulated by law – the market tension is increasing. There are cases of blocking and imposing fines on manufacturers through the format of the OOP number and the requirements for the withdrawal of quality products. Trading networks send signals about the possible refusal to accept medical products through “inappropriate labeling”. That is, the problem not only led to excessive costs and complications of the activities of producers. It continues to contain the risk of further suspension of the relevant medical products and to be a reason for the potential imposition of fines.

Therefore, the European Business Association appeals to the Ministry of Economic Development and Trade to ensure that amendments to the Order No. 244 are adopted as soon as possible. At the same time, we appealed to the Ministry of Health of Ukraine with a request to explain the legitimacy of the format of the OOO number in the market. We believe that such an explanation from the Ministry of Health of Ukraine, which is the body of technical regulation in the field of quality control and implementation of medical products, will allow now and in the future to suspend the circulation of quality medical products for the above-mentioned reasons during the implementation of state market surveillance.

Additionally, we draw attention to the fact that the fact that the above problem has nothing to do with the quality of medical products is quite understandable. Products are already certified in the country of production; for the most part, has a CE mark, and, accordingly, was subsequently certified in Ukraine. Obviously, the problem is of a purely technical nature and consists in the lack of transparent rules that are timely reported to the market. Nevertheless, unfortunately, it has already become a major obstacle to the flow of medical products. So, it is expedient to accelerate its final decision.

* The Order of the Ministry of Economic Development and Trade of Ukraine “On Approval of the Procedure for the Establishment and Maintenance of the Register of Designated Bodies for the Evaluation of Conformity and Recognized Independent Organizations and the Procedure for the Establishment and Maintenance of Databases Obtained by the Appointing Authority from Designated Bodies of Conformity Assessment” No. 244 of 10 February 2016