02.03.2020 Dear colleagues!
Be careful when forming requirements for medical equipment!
We inform the medical community about an extremely important rule:
in accordance with paragraph 7 of Appendix 2 to the Technical Regulations for medical devices, approved by the Decree of the Cabinet of Ministers of Ukraine No. 753 dated October 2, 2013:
"7. If several criteria can be applied to one medical device, taking into account the operational characteristics specified by the manufacturer for the medical device, such a device belongs to a higher class."
For example, blood banks are not allowed to use equipment for the collection, processing, storage of blood and its components with a safety class below IIa.
We also draw your attention to the “Methodical recommendations“ Classification of medical devices ”, approved by Order of the Ministry of Health No. 142 dated 01.22.2020.
These guidelines are designed for unambiguously interpret the norms of Technical Regulations for medical devices, approved by the Decree of the Cabinet of Ministers of Ukraine No. 753 dated 02.10.2013.
Therefore, we ask you to pay attention to these extremely important subtleties when purchasing equipment and consumables for your organization.
Sincerely, Ledum Ltd