In line with the requirements of the EU In Vitro Diagnostic Regulation (EU IVDR, 2017/746), we have assessed the intended purpose and use of our CE-marked IVD products in clinical diagnostic laboratories. We have concluded that the intended use of these products, for performance assessment of laboratory assays, does not require CE-marking.
Therefore, our CE-marked in vitro diagnostic (IVD) quality control reagents will only be valid now until 26 May 2025, 23:59 (GMT). After this date, these products will be withdrawn, and the CE mark will no longer be valid on any of these purchased products.
We are fully committed to providing products that meet the needs of our customers and adhere to the high-quality standards expected from us. Our expert scientists are currently developing new, alternative high-quality NIBSC Reference Reagents that can be used for performance assessment of laboratory assays.
It is legally important that after the 26 May 2025, we kindly request that any of these CE-marked products that have already been purchased for use in your laboratories, are either returned to us for destruction or destroyed within your facilities and evidence of this destruction returned to us as confirmation that these products are no longer in use.
In addition, we strongly recommend that any orders placed from today only contain the number of units required for use until the 26 May 2025, 23:59 (GMT).
For further assistance, please contact us on diagnostics@mhra.gov.uk
The CE-marked range consist of serology and nucleic acid test run controls for use when testing blood for pathogenic viruses such as:
There are also standards for:
There are currently over 20 CE marked working standards available
The QCRU range consists of CE-marked quality control serum reagents for:
There are currently over 30 QCRU reagents available.
The Clinical Virology Network (CVN) range was developed with the assistance of the UK Clinical Virology Network. They consist of CE marked reference materials for use with Nucleic Acid Amplification Techniques for a range of clinically significant viruses. There are currently over 20 CVN reference materials available
All IFU’s are available in English. Translations into other languages are available where there is sufficient demand.Please refer to the current list of available IFU translations (PDF, 305KB)