On 26 October 2016 in response to the European Business Association’s letter the State Expert Center (SEC) informed that it developed the amendments to the Technical Regulations on Medical Devices concerning the assessment of substances as a part of medical devices. Also, SEC informed the Association that it was in the process of developing the Draft Procedure to provide relevant scientific consultations on the issue.
The effective legislation hasn’t yet established any procedure for the SEC to expertise the mentioned substances upon applicants’ requests. Simultaneously, according to the Technical Regulations it is necessary to perform an additional check of effectiveness, safety and quality of a substance that can be treated as a medical drug when used separately, which is a part of a medical device.
Such a situation negatively effects both SEC, conformity evaluation bodies and applicants’ activities along with setting up a barrier for the medical devices’ supply and circulation at the Ukraine’s market.
The Association is thankful to both MOH and SEC for their understanding of the very problem, the important steps towards its resolution and is looking forward to the soonest adoption of the developed amendments which would set out transparent and well-regulated rules for all stakeholders.
Requirements of Technical Regulations according to which it is necessary to perform an additional check of effectiveness, safety and quality of a substance that can be treated as a medical drug when used separately, are approved by the CMU Resolutions No.753 and No.755 dated 2 October 2013:
– Item 4 of Chapter II in the Annex 1 of the Technical Regulation on Medical Devices;
– Item 11 in the Annex 1 of the Technical Regulation on Active Medical Devices that are Implanted.