Donation Notices are granted for new and second-hand medical devices.
According to legislation in force, donation recipients are healthcare entities with in-house pharmacy, social welfare entities or non-governmental organisations employing authorised healthcare personnel – doctor(s) or pharmacist(s).
In accordance with European standards for medical devices, medical devices bearing the CE mark of conformity only are accepted as donations, submitted to conformity assessment prior to placing on the market.
For second-hand medical devices, the consumed duration of donated medical devices shall be at least 3 years less than the normal lifetime established by applicable law (under the donor’s own responsibility declaration).
Only medical devices are accepted as donations that are provided with all the necessary accessories to allow use in accordance with the manufacturer’s intended purpose, are operational and compliant with functional performance and applicable security requirements under the donor’s own responsibility declaration).
Donated medical devices shall be accompanied by instructions for use, as appropriate.
The application form is available for download on the Forms and Fees page.
No fees are charged for grant of Donation Notices.