Our medical devices, the KIRSCH Blood Bank Refrigerators and Blood Plasma Freezers, meet all legal requirements and have been certified according to Regulation (EU) 2017/745 (MDR) since March 28, 2022. The certification was carried out by the notified body mdc medical device certification GmbH (CE0483).
The MDR (Medical Device Regulation) replaces the existing medical device directives (93/42/EEC).
By obtaining MDR certification for our blood cooling devices and therefore fulfilling all strict requirements , we are contributing to the better protection of public health and patient safety.
The certificate and an overview of the products covered by this certificate including supplementary information and conditions can be found here.