External consultations – draft legislative path for the assessment and inclusion of innovative medical devices in the list of guaranteed services
We invite you to participate in external consultations on the draft legislative path for the assessment and inclusion of innovative medical devices, including digital solutions, in the list of guaranteed services.
The purpose of the consultations is to gather opinions, comments, and suggestions that will enable further refinement of the proposed model and its adaptation to the needs of the Polish healthcare system.
The proposal is described in the document entitled “System of public financing for innovative medical devices – assessment and directions for change”.
The draft was developed on the basis of:
- a review of available scientific evidence,
- an analysis of solutions in place in selected countries,
- expert consultations with representatives of key stakeholders in the medical device industry,
- consultations with representatives of the Ministry of Health,
- cooperation with project partners.
The following were prepared as part of the work:
- Analytical report – containing proposals for directional solutions developed by AOTMiT and proposals from representatives of the medical device industry, including proposals for a legislative path for the assessment of innovative medical devices, covering various scenarios, differentiated in terms of implementation possibilities and the degree of integration with existing health care system mechanisms.
- Additional materials – attached to the Report, including the results of a literature review, a survey, and an analysis of international solutions.
- Appendix to the Report – containing comments submitted during internal consultations by the project partners.
We invite you to participate in the consultations – opinions and proposals can be submitted until August 18, 2025.
Please send your comments on the proposed solutions – in particular regarding the legislative path scenarios – to the following e-mail address: SekretariatWS@aotm.gov.pl
The draft documents and the form for submitting comments can be downloaded below.