Source

Commission Implementing Decision (EU) 2019/1244 of 1 July 2019 amending Decision 2002/364/EC as regards requirements for HIV and HCV antigen and antibody combined tests and as regards requirements for nucleic acid amplification techniques with respect to reference materials and qualitative HIV assays (notified under document C(2019) 4632) (Text with EEA relevance.)

Implementing Decision (EU) 2019/1244 · Decision · 4 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

Open ↗

The Annex to Decision 2002/364/EC is amended in accordance with the Annex to this Decision.

Article 2

Open ↗

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 ( 4 ) ; (b) the common technical specifications laid down in the Annex to Decision 2002/364/EC as amended by this Decision.

Article 3

Open ↗

This Decision is addressed to the Member States.

Supplementary provisions

ANNEXSupplementary provisions

Open ↗

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. Additional requirements for HIV and HCV antigen and antibody combined tests. 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: ‘ Table 1 Screening assays: anti-HIV 1/2, HIV 1/2 Ag/Ab, anti-HTLV I/II, anti-HCV, HCV Ag/Ab, HBsAg, anti-HBc 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-1 100 HIV-2 including 40 non-B-subtypes, all available HIV/1 subtypes shall be represented by at least 3 samples per subtype 300 HTLV-I 100 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 400 including subtype-consideration 400 including evaluation of other HBV-markers Sero-conversion panels 20 panels 10 further panels (at Notified Body or manufacturer) To be defined when available 20 panels 10 further panels (at Notified Body or manufacturer) 20 panels 10 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: ‘ Table 5 HIV 1 antigen, HIV Ag/Ab, HCV antigen, HCV Ag/Ab 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 positive 50 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 ( 1 ) 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 donations 200 clinical samples 50 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 ( 1 ) The total number of seroconversion panels for combined Ag/Ab assays (from tables 1 and 5) need not be greater than 30.’

Other acts of the same type

Council Decision (EU) 2026/1430 of 22 June 2026 on the position to be taken on behalf of the European Union within the ninth session of the ad hoc Committee on Legal Affairs and International Cooperation of the Intergovernmental Organisation for International Carriage by Rail (OTIF) concerning the proposed amendments to the Rules of Procedure of the ad hoc Committee Council Decision (EU) 2026/1539 of 22 June 2026 on the position to be taken on behalf of the European Union within the Council of Members of the International Olive Council with regard to the organoleptic assessment method for virgin olive oil Commission Implementing Decision (EU) 2026/1403 of 19 June 2026 amending Implementing Decision (EU) 2024/3238 concerning certain emergency measures relating to infection with peste des petits ruminants virus in Bulgaria (notified under document C(2026) 4392)Commission Implementing Decision (EU) 2026/1387 of 17 June 2026 amending Implementing Decision (EU) 2025/638 concerning certain emergency measures relating to infection with peste des petits ruminants virus in Romania (notified under document C(2026) 4305)Commission Implementing Decision (EU) 2026/1389 of 17 June 2026 concerning certain interim emergency measures relating to infection with peste des petits ruminants virus in Croatia (notified under document C(2026) 4337)Decision (EU) 2026/1543 of the European Parliament and of the Council of 17 June 2026 on the mobilisation of the European Globalisation Adjustment Fund for Displaced Workers following an application from Belgium – EGF/2025/009 BE/Soliver Council Decision of 16 June 2026 replacing a member of the Advisory Committee for the Coordination of Social Security Systems for Sweden Council Decision of 16 June 2026 replacing an alternate member of the Advisory Committee on Safety and Health at Work for Luxembourg Council Decision of 16 June 2026 adopting the Council’s position on draft amending budget No 1 to the general budget for 2026 Council Decision of 16 June 2026 replacing a member of the Management Board of the European Centre for the Development of Vocational Training (Cedefop) for Luxembourg Council Decision (EU) 2026/1400 of 16 June 2026 appointing a member and an alternate member, proposed by the Republic of Austria, of the Committee of the Regions Decision of the Bureau of the European Parliament of 15 June 2026 amending the Implementing Measures for the Statute for Members of the European Parliament

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next

Browse all EU Legal ActsEvery instrument by type and year, full text free to read section by sectionEuropean Union legislation EU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and year European Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview