Improve Medical (en)

Article 29 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”, in particular, stipulates that:

• in the cases specified in the technical regulations, which provide for the use of conformity assessment procedures, products and/or other objects specified by such technical regulations (technical data plate, packaging, accompanying documents, etc.) must be marked with the conformity with the technical regulations;
• the rules and conditions for the marking of conformity with the technical regulations shall be established by the technical regulations, which provide for its application, and if such rules and conditions are not established by certain technical regulations, the Cabinet of Ministers of Ukraine;
• if required by technical regulations, to mark conformity with technical regulations included the identification number of notified body involved in conformity assessment, which is applied in accordance with the requirements of relevant technical regulations.

The conditions of the sign of conformity were also met technical regulations approved by Resolution of the Cabinet of Ministers of Ukraine dated December 30, 2015, № 1184 “On approval of the form, description of the mark of conformity with technical regulations, rules, and conditions for its application”.

In accordance with Article 35 of the above-mentioned Law, the central executive authority, which appoints conformity assessment bodies (Ministry of Economic Development and Trade), assigns identification numbers to the designated conformity assessment bodies.

In this case, only one identification number is assigned to each assigned conformity assessment body, regardless of whether it has been designated in accordance with several technical regulations.

In the orders of the Ministry of Economic Development and Trade on the designation of conformity assessment bodies for the assessment of conformity with the requirements of the relevant technical regulation, the identification number assigned to the designated conformity assessment body in UA.TR.YYY format shall be indicated.

In addition, the decision on the appointment of a conformity assessment authority to perform an assessment of compliance with the requirements of the relevant technical regulation shall also indicate the identification number assigned to the designated conformity assessment body in UA.TR.YYY format.

The above-mentioned normative-legal act amended paragraph 3 of the rules and conditions of the sign of conformity with the technical regulations approved by the decree of the Cabinet of Ministers of Ukraine dated December 30, 2015, No. 1184 ” On approval of the form, description of the mark of conformity to technical regulations, rules and conditions for its application ” .

Thus, during the marking of products by the mark of conformity to technical regulations, operators of the market from 04.01.2018 are allowed to affix the identification number of the designated conformity assessment body if such an authority was involved at the stage of production control, as in the full UA.TR. 120, and in the abbreviated format 120.

By this date, it was allowed to apply the identification number of the designated conformity assessment body to medical products only in full format , as evidenced by the explanation of the Ministry of Economic Development and Trade of Ukraine regarding the format of the identification number of the designated assessment authority from January 26, 2017 No. 3633-06 / 2446-03 .

At the same time, the Ministry of Health of Ukraine as a body of technical regulation in the field of medical products, taking into account the explanations of the Ministry of Economic Development, issues a clarification letter dated 08.10.2017  to the market surveillance authority for medical products of the State Medical Service of Ukraine, in which it is noted that the use of a serial number in the format “YYY” under the national conformity marker allows identification of the conformity assessment body that issued the certificate of conformity for this product.

Such a conclusion of the Ministry of Health of Ukraine issued on numerous appeals of the operators of the market of medical products and in connection with the strategic importance for the security of the state availability of the sufficient number of medical products in the customs territory of Ukraine.

At the same time, the Ministry of Health of Ukraine stresses that the national mark of conformity of Ukraine is unique and not repeated in any country in the world. On the application of the serial number of the conformity assessment body in the abbreviated format ” YYY ” under the national conformity mark can affect the quality.

However, letters from ministries and other central executive bodies are not normative and legal acts, they are only explanatory, informational and do not establish legal norms.

Designated conformity assessment body IMPROVE MEDICAL has an identification number (ID) UA.TR.120.

IMPROVE MEDICAL from the beginning of its activities (appointment) is doing exclusively by the current legislation regulating the field of medical products, and has always emphasized to its clients the correctness of marking the national conformity mark in the full format, namely, UA. TR .120, since the format was only allowed in Ukraine from January 4, 2018, in view of the adoption of the resolution The Cabinet of Ministers of Ukraine No. 1027 dated December 20, 2017, “On Amendments to Clause 3 of the Rules and Terms of Affixing the Sign of Compliance with the Technical Regulations”.

Violations connected with the indication of the ID of the conformity assessment body, in 2017, often became subject to the application of penalties by the market surveillance authority, the State Service of Internal Affairs, during its implementation of its and its territorial bodies of measures.

Experts of IMPROVE MEDICAL February 22, 2018, are going to get special webinar on which particular detail will consider medical devices regulation.

During the webinar as a bonus, we will make a master class; it will be held to complete the application for conformity assessment work.

All registered participants before the event can prepare a list of questions on the subject and send them to our speakers by contacting Tetyana Kolesnik on +38 0443555030 or by email kolesnik@improvemed.space.