Commission Implementing Decision (EU) 2020/350 of 28 February 2020 amending Decision 2002/364/EC as regards definitions of first–line assays and confirmatory assays, requirements for devices for self-testing and requirements for HIV and HCV rapid tests, confirmatory and supplementary assays (notified under document C(2020) 1086) (Text with EEA relevance)

Implementing Decision (EU) 2020/350 · 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

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

Article 2

1. This Decision shall apply from 2 March 2021. 2. Notwithstanding paragraph 1, from 2 March 2020 until 1 July 2020 Member States shall apply the presumption of compliance laid down in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with any of the following: (a) the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Decision 2011/869/EU ( 4 ) ; (b) the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Implementing Decision (EU) 2019/1244 ( 5 ) ; (c) the common technical specifications laid down in Decision 2002/364/EC as amended by this Decision. 3. Notwithstanding paragraph 1, from 2 July 2020 until 1 March 2021 Member States shall apply the presumption of compliance laid down in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with either of the following: (a) the common technical specifications laid down in Decision 2002/364/EC as amended by Implementing Decision (EU) 2019/1244; (b) the common technical specifications laid down in Decision 2002/364/EC as amended by this Decision.

Article 3

This Decision is addressed to the Member States.

Supplementary provisions

ANNEXSupplementary provisions

ANNEX The Annex to Decision 2002/364/EC is amended as follows: 1. Section 2 is amended as follows: (a) the following definition of ‘First line assay’ is inserted between the definition of ‘Whole system failure rate’ and the definition of ‘Confirmation assay’: ‘ First-line assay First-line assay means an assay used to detect a marker or analyte, and which may be followed by a confirmatory assay. Devices intended solely to be used to monitor a previously determined marker or analyte are not considered first-line assays.’; (b) the definition of ‘Confirmation assay’ is replaced by the following: ‘ Confirmatory assay Confirmatory assay means an assay used for the confirmation of a reactive result from a first-line assay.’; 2. Section 3 is amended as follows: (a) 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, Table 3, Table 4 and Table 5, which apply to them taking account of the intended purpose of the devices concerned, virus type and entities to be detected (antigen and/or antibody). See also principle 3.1.11 for first-line assays.’; (b) Sub-section 3.1.3 is replaced by the following: ‘3.1.3. Devices for self-testing shall meet the same CTS requirements for sensitivity and specificity as respective devices for professional use. Relevant parts of the performance evaluation shall be carried out (or repeated) by appropriate lay users to validate the operation of the device and the instructions for use. The lay users selected for the performance evaluation shall be representative of the intended users groups. Performance evaluation of a device for self-testing shall include, for each body fluid claimed for use with the device, e.g. whole blood, urine, saliva, etc., at least 200 lay users that are known positive for the infection and at least 400 lay users that do not know their status, of which at least 200 are at high risk of acquiring the infection. The sensitivity and specificity of the device for self-testing in the hands of lay users shall be defined against the confirmed patient infectious status.’; (c) Sub-section 3.1.9 is replaced by the following: ‘3.1.9. Performance evaluation of first line assays shall include 25 positive (if available in the case of rare infections) ‘same day’ fresh serum samples (≤ 1 day after sampling).’; (d) Sub-section 3.1.11 is replaced by the following: ‘3.1.11. For performance evaluations for first line assays (Table 1 and Table 3) blood donor populations shall be investigated from at least two blood donation centers and consist of consecutive blood donations, which have not been selected to exclude first time donors.’; (e) Sub-section 3.4.2 is replaced by the following: ‘3.4.2. The manufacturer’s batch release testing for first line assays shall include at least 100 specimens negative for the relevant analyte.’. 3. Table 1 is replaced by the following: ‘Table 1 First-line assays, excluding rapid tests: 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’ 4. Table 3 is replaced by the following: ‘Table 3 Rapid tests: anti-HIV 1/2, HIV 1/2 Ag/Ab, anti-HCV, HCV Ag/Ab, HBsAg, anti-HBc, anti-HTLV I and II anti-HIV 1/2, HIV 1/2 Ag/Ab anti-HCV, HCV Ag/Ab HBsAg anti-HBc anti-HTLV I and II Acceptance criteria Diagnostic sensitivity Positive specimens Same criteria as in Table 1 Same criteria as in Table 1 Same criteria as in Table 1 Same criteria as in Table 1 Same criteria as in Table 1 Same criteria as in Table 1 Sero-conversion panels Same criteria as in Table 1 Same criteria as in Table 1 Same criteria as in Table 1 Same criteria as in Table 1 Same criteria as in Table 1 Same criteria as in Table 1 Diagnostic specificity Negative specimens 2 1 000 blood donations 1 000 blood donations 1 000 blood donations 1 000 blood donations 1 000 blood donations ≥ 99 % (anti-HBc: ≥ 96 %)’ 200 clinical specimens 200 clinical specimens 200 clinical specimens 200 clinical specimens 200 clinical specimens 200 samples from pregnant women 200 samples from pregnant women 200 samples from pregnant women 200 samples from pregnant women 100 potentially interfering samples 100 potentially interfering samples 100 potentially interfering samples 100 potentially interfering samples 100 potentially interfering samples 5. Table 4 is replaced by the following: ‘Table 4 Confirmatory and supplementary assays for anti-HIV 1/ 2, HIV 1/2 Ag/Ab, anti-HTLV I and II, anti-HCV, HCV Ag/Ab, HBsAg anti-HIV 1/2, HIV 1/2 Ag/Ab confirmatory assays anti-HTLV I and II confirmatory assays anti-HCV, HCV Ag/Ab supplementary assays HBsAg confirmatory assays Acceptance criteria Diagnostic sensitivity Positive specimens 200 HIV-1 and 100 HIV-2 Including samples from different stages of infection and reflecting different antibody patterns 200 HTLV-I and 100 HTLV-II 300 HCV (positive samples) Including samples from different stages of infection and reflecting different antibody patterns. Genotypes 1 – 4: > 20 samples (including non-a subtypes of genotype 4; Genotype 5: > 5 samples; Genotype 6: if available 300 HBsAg Including samples from different stages of infection 20 ‘high pos’ samples (>26 IU/ml); 20 samples in the cut-off range Correct identification as positive (or indeterminate), not negative Sero-conversion panels 15 sero-conversion panels/low titre panels 15 sero-conversion panels/low titre panels 15 sero-conversion panels/low titre panels Analytical sensitivity Standards Third International Standard for HBsAg, subtypes ayw1/adw2, HBV genotype B4, NIBSC code: 12/226 Diagnostic specificity Negative specimens 200 blood donations 200 blood donations 200 blood donations 10 false positives as available from the performance evaluation of the first line assay ( 1 ) . No false-positive results/ ( 1 ) no neutralisation 200 clinical samples including pregnant women 200 clinical samples including pregnant women 200 clinical samples including pregnant women 50 potentially interfering samples, including samples with indeterminate results in other confirmatory assays 50 potentially interfering samples, including samples with indeterminate results in other confirmatory assays 50 potentially interfering samples, including samples with indeterminate results in other supplementary assays 50 potentially interfering samples ( 1 ) Acceptance criteria: no neutralisation for HBsAg confirmatory assay.’

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

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