
Article 1 
The Annex to Decision 2002/364/EC is amended in accordance with the Annex to this Decision.
Article 2 
This Decision shall apply from 2 July 2020.
Until that date, Member States shall apply the presumption of compliance referred to in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with either of the following specifications:

((a)) the common technical specifications laid down in the Annex to Decision 2002/364/EC as amended by Commission Decision 2011/869/EU;
((b)) the common technical specifications laid down in the Annex to Decision 2002/364/EC as amended by this Decision.
Article 3 
This Decision is addressed to the Member States.
Done at Brussels, 1 July 2019.
For the Commission
Elżbieta BIEŃKOWSKA
Member of the Commission
ANNEX

The Annex to Decision 2002/364/EC is amended as follows:

((1)) Sub-section 3.1.1 is replaced by the following:
'
3.1.1 Devices which detect virus infections shall meet the requirements for sensitivity and specificity set out in Table 1 and Table 5 according to virus type and entities detected (antigen and/or antibody). See also principle 3.1.11 for screening assays.
'
((2)) Section 3.2 is replaced by the following:
'
3.2.  3.2.1. HIV antigen and antibody combined tests intended for the detection of HIV-1 p24 antigen and HIV-1/2 antibody shall meet the requirements for sensitivity and specificity set out in Table 1 and Table 5.
 3.2.2. Hepatitis C virus (HCV) antigen and antibody combined tests intended for the detection of HCV antigen and HCV antibody shall meet the requirements for sensitivity and specificity set out in Table 1 and Table 5. HCV seroconversion panels for the evaluation of HCV antigen and antibody combined tests shall start with one or more negative bleeds and comprise panel members from early HCV infection (HCV core antigen and/or HCV RNA positive but anti-HCV negative). HCV antigen and antibody combined tests shall demonstrate enhanced sensitivity in early HCV infection when compared to HCV antibody only tests.
'
((3)) Sub-section 3.3.2 is replaced by the following:
'
3.3.2. The analytical sensitivity or detection limit for NAT assays shall be expressed by the 95 % positive cut-off value. This is the analyte concentration where 95 % of test runs give positive results following serial dilutions of an international reference material, where available, such as a World Health Organisation (WHO) International Standard or reference material calibrated against a WHO International Standard.
'
((4)) The following sub-sections 3.3.2a and 3.3.2b are inserted:
'
3.3.2a. Qualitative HIV NAT assays intended to be used to detect the presence of HIV in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration shall be designed to detect both HIV-1 and HIV-2.

3.3.2b. Qualitative HIV NAT assays, other than virus typing assays, shall be designed to compensate for the potential failure of a HIV-1 NAT target region, e.g. by using two independent target regions.
'
((5)) Table 1 is replaced by the following:
'
  anti-HIV 1/2, HIV 1/2 Ag/Ab Anti-HTLV-I/II anti-HCV, HCV Ag/Ab HBsAg Anti-HBc
Diagnostic sensitivity Positive specimens 400 HIV-1100 HIV-2including 40 non-B-subtypes, all available HIV/1 subtypes shall be represented by at least 3 samples per subtype 300 HTLV-I100 HTLV-II 400 (positive samples)Including samples from different stages of infection and reflecting different antibody patterns.Genotype 1-4: > 20 samples per genotype (including non-a subtypes of genotype 4);5: > 5 samples;6: if available 400including subtype-consideration 400including evaluation of other HBV-markers
Sero-conversion panels 20 panels10 further panels (at Notified Body or manufacturer) To be defined when available 20 panels10 further panels (at Notified Body or manufacturer) 20 panels10 further panels (at Notified Body or manufacturer) To be defined when available
Analytical sensitivity Standards    0,130 IU/ml (WHO International Standard: Third International Standard for HBsAg, subtypes ayw1/adw2, HBV genotype B4, NIBSC code: 12/226) 
Specificity Unselected donors (including first-time donors) 5 000 5 000 5 000 5 000 5 000
Hospitalized patients 200 200 200 200 200
Potentially cross-reacting blood-specimens (RF+, related viruses, pregnant women, etc.) 100 100 100 100 100'
((6)) Table 5 is replaced by the following:
'
 HIV-1 antigen and HIV Ag/Ab assays HCV antigen and HCV Ag/Ab assays Acceptance criteria
Diagnostic sensitivity Positive specimens 50 HIV-1 antigen positive50 cell culture supernatants including different HIV-1 subtypes and HIV-2 25 HCV core antigen and/or HCV RNA positive but anti-HCV negative samples, comprising HCV genotypes 1-6 (if a genotype is not available, a justification shall be made) See general principle in § 3.1.8
Sero-conversion panels 20 sero-conversion panels/low titre panels 20 sero-conversion panels/low titre panels 
Analytical sensitivity Standards HIV-1 p24 Antigen, First International Reference Reagent, NIBSC code: 90/636 HCV core antigen detection limit shall be investigated using dilutions of the WHO International HCV core antigen Standard: (HCV core Ag product code: PEI 129096/12) For HIV-1 p24 antigen: ≤ 2 IU/ml
Diagnostic specificity  200 blood donations200 clinical samples50 potentially interfering samples 200 blood donations, 200 clinical samples, 50 potentially interfering samples ≥ 99,5 % after neutralisation or, if no neutralisation test available, after resolution of the sample status according to general principles in § 3.1.5
'
