The new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) entered into application on 26 May 2022. The new regulation will have a progressive roll-out for products depending on their classification.
The transition period for non-sterile class A products ended on 26 May 2022. After this, the classification of some of Aidian's products or product components has changed and we are happy to announce that those items are currently CE marked in compliance to IVDR. The new IVD Regulation has not affected our product availability or delivery times and all deliveries continue as before.
Below you can find a list of those products and product components currently CE marked in compliance to IVDR. This list comprises components packed inside a kit and separately sold items. Whole reagent kits will be CE marked according to IVDR later.
Aidian's products and product components currently CE marked in compliance to IVDR:
- 133893 QuikRead go® Instrument
- 154457 QuikRead go® Sample Collector 1µl
- 153211 QuikRead go® Sample Collector 10μl
- 147851 QuikRead go® Capillaries
- 151052 QuikRead® iFOB Sampling Set
- 67962 QuikRead® Capillaries
- 67966 QuikRead® Plungers