As you may be aware in May 2022 the IVD regulations were replaced with the new IVDR regulations, and since May 2022 Atom Scientifics products are fully IVDR complaint.
In addition to IVDR, all products remain CE marked in our global markets, however post-brexit the UK has adopted the UKCA mark to replace the CE mark, which all of our products are compliant with.
The IVDR regulations require any product that is used in a Medical or Diagnostic application to be registered under IVDR.
The ultimate aim of this change is to increase quality and consistency of diagnostic products as well as ensuring full traceability through the supply chain for all components.
It is important to note that any product not registered under IVDR should only be used in research applications, and should not be used in diagnostic applications as recommended by UKAS.
Atom Scientific is one of the few companies that has achieved IVDR compliance, alongside upgrading our Quality Management System to be ISO13485 compliant.
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