The Ukrainian Ministry of Health recently announced the following:
– Technical Regulations on Medical Devices
– Technical Regulations on Medical devices for in vitro diagnostics
– Technical Regulations regarding Active Implantable Medical Devices (AIMD)
These recommendations are harmonized with relevant MEDDEV guidance documents that specify technical regulations for medical devices (for in votro diagnostics) and AIMD.
See the comparison table below.
While these recommendations are not mandatory, they help companies effectively apply technical regulations.