NIBSC - CE-marked products valid until 26 May 2025

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 After this date, these products will be withdrawn, and the CE mark will no longer be valid on any of these purchased products.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

Discontinued CE-marked IVD products effective after 26 May 2025

Product Description	NIBSC Code	Classification
The British Standard for Anti-D antibodies	73/517	Annex II List B
The British Standard for Anti-c antibodies	84/628	Annex II List B
Anti-H. influenza type B Polysaccharide	09/222	Self-certified
British Working Standard for Anti-HIV-1	99/750	Annex II List A
British Working Standard for Anti-HIV-1 1 in 5 Dilution	99/710	Annex II List A
Monitor Sample for Anti-HIV-2	99/674	Annex II List A
Monitor Sample for Anti-HTLV-1	03/104	Annex II List A
British Working Standard for Anti-HCV	19/240	Annex II List A
NIBSC Monitor Sample for HBsAg 0.05 IU/mL	07/286	Annex II List A
British Working Standard for HBsAg 0.2 IU/mL	07/288	Annex II List A
HBV / HCV / HIV Triplex Reagent (NAT)	14/198	Annex II List A
NHS Winter Multiplex Working Reagent for NAT	20/170	Self-certified
Clinical Virology Multiplex I: Immunodeficiency panel working reagent for NAT	15/130	Annex II List B
Human Measles virus for NAT	13/168	Self-certified
Anti-HIV-1: Quality Control Serum: Sample 1	QCRHIV1QC1	Annex II List A
Anti-HIV-1: Quality Control Serum: Sample 2	QCRHIV1QC2	Annex II List A
Anti-HIV-1: Quality Control Serum: Sample 3	QCRHIV1QC3	Annex II List A
Anti-HIV-1: Quality Control Serum: Sample 5	QCRHIV1QC5	Annex II List A
Anti-HIV-2 Quality Control Serum: Sample 2	QCRHIV2QC2	Annex II List A
Anti-HIV-2 Quality Control Serum: Sample 3	QCRHIV2QC3	Annex II List A
Anti-HIV-2 Quality Control Serum: Sample 4	QCRHIV2QC4	Annex II List A
HIV1 p24 Antigen: Quality Control Serum: Sample 1	QCRHIV1p24QC1	Annex II List A
HIV1 p24 Antigen: Quality Control Serum: Sample 2	QCRHIV1p24QC2	Annex II List A
HIV-1 Rapid Test Device: Quality Control Serum: Sample 1	QCRHIV1RTDQC1	Annex II List A
Anti-HCV Quality Control Serum: Sample 1	QCRHCVQC1	Annex II List A
Anti-HBs Quality Control Serum: Sample 1	QCRHBsQC1	Annex II List A
HBsAg Quality Control Serum: Sample 1	QCRHBsGQC1	Annex II List A
HBsAg Quality Control Serum: Sample 2	QCRHBsGQC2	Annex II List A
Total Anti-HBc Quality Control Serum: Sample 1	QCRTHBcQC1	Annex II List A
Total Anti-HBc Quality Control Serum: Sample 2	QCRTHBcQC2	Annex II List A
Anti-HBe Quality Control Serum: Sample 1	QCRHBeQC1	Annex II List A
lgM Anti-HBc Quality Control Serum: Sample 1	QCRHBcIgMQC1	Annex II List A
Anti-CMV Quality Control Serum: Sample 1	QCRCMVQC1	Annex II List B
Anti-Rubella Quality Control Serum: Sample 1	QCRRUBQC1	Annex II List B
Anti-Rubella Quality Control Serum Sample 2	QCRRUBQC2	Annex II List B
Anti-Rubella lgM Quality Control Serum Sample 1	QCRRUBIgMQC1	Annex II List B
Anti-Toxoplasma Quality Control Serum: Sample 1	QCRTOXOQC1	Annex II List B
IgM Anti-CMV Quality Control Reagent 1	QCRCMVIgMQC1	Annex II List B
IgM Anti-Toxoplasma gondii Quality Control Reagent 1	QCRTOXOIgMQC1	Annex II List B
Total Anti-HAV Quality Control Serum: Sample 1	QCRTHAVQC1	Self-certified
IgM Anti-HAV Quality Control Serum: Sample 2	QCRHAVIgMQC2	Self-certified
Anti-Malaria Quality Control Serum: Sample 1	QCRMALQC1	Self-certified
Anti-Syphilis Quality Control Serum: Sample 1	QCRSYPHQC1	Self-certified
Anti-Syphilis Quality Control Serum: Sample 2	QCRSYPHQC2	Self-certified
Anti-VZV Quality Control Serum: Sample 1	QCRVZVQC1	Self-certified
Anti-HSV-1 Quality Control Serum: Sample 1	QCRHSV1QC1	Self-certified
Anti-HSV-2 Quality Control Serum: Sample 1	QCRHSV2QC1	Self-certified
Negative Quality Control Serum: Sample 1	QCRNEGQC1	Self-certified
Anti-LYME Quality Control Reagent 1	QCRLYMEQC1	Self-certified
IgM Anti-LYME Quality Control Reagent 1	QCRLYMEIgMQC1	Self-certified
Anti-Measles Quality Control Reagent 1	QCRMEASQC1	Self-certified
Anti-Mumps Quality Control Reagent 1	QCRMUMPSQC1	Self-certified
Anti-Parvovirus B19 Quality Control Reagent 1	QCRPARVB19QC1	Self-certified
Anti-Parvovirus B19 IgM Quality Control Reagent 1	QCRPARVB19IgMQC1	Self-certified
Anti-Hepatitis E Quality Control Serum Sample 1	QCRHEVQC1	Self-certified
IgM Anti-Hepatitis E Quality Control Reagent	QCRHEVIgMQC1	Self-certified
Anti-VCA IgG Quality Control	QCREBVVCAQC1	Self-certified
EBV Negative Quality Control Serum Sample 1	QCREBVNEGQC1	Self-certified
Anti-VCA IgM Quality Control	QCREBVIgMQC1	Self-certified
Anti-SARS-CoV-2 Quality Control Serum Sample 1	QCRSARSCoV2QC1	Self-certified
Ferritin Quality Control Serum Sample 1	QCRFERRQC1	Self-certified
British Standard for varicella zoster antibody	90/690	Self-certified