The meeting was attended by: the Director of the Center Mykhailo Babenko, the Deputy Director for Clinical Affairs Mykhailo Lobas, the Director of the Department of Health Technology Assessment, State Registers Administration, and Price Monitoring Oresta Piniazhko, and specialists of the Center.
During the meeting, Oresta Piniazhko reported that the development of the Guideline on health technology assessment for medical devices is ongoing. Currently, HTA experts are analyzing the best international practices of conducting HTA for medical devices by EUnetHTA, NICE (National Institute for Health and Care Excellence, United Kingdom), HAS (National Health Authority of France) and are working through the guidelines of the Netherlands, Ireland and Sweden.
After the draft Guideline is developed, it will be published for public discussion and finalized in accordance with the proposals received, taking into account national specifics.
During the working meeting, a number of issues requiring regulation were also raised: the absence in Ukraine of regulatory documents governing market access and circulation of medical devices, and the absence of a state register of medical devices.
Representatives of the EBA noted that due to the implementation, from May 26, 2021, of the provisions of Regulation of the European Parliament and of the Council (EU) 2017/745 of 05.04.2017 and the provisions of Regulation of the European Parliament and of the Council (EU) 2017/746 of 05.04.2017, the requirements for manufacturers of medical devices and the market surveillance requirements are changing significantly.
The parties agreed on further cooperation and holding meetings on this issue on a regular basis in order to:
- Develop a unified position;
- Align with the HTA roadmap;
- Define clear classification criteria for medical devices and the categories of medical devices subject to HTA;
- Promote the development of a separate Law on medical devices, etc.
