Article 1The technical specifications set out in the Annex to this...
Article 2This Decision is addressed to the Member States.
ANNEXCOMMON TECHNICAL SPECIFICATIONS (CTS) FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES
1.SCOPE 2.DEFINITIONS AND TERMS (Diagnostic) sensitivity True positive False negative (Diagnostic) specificity False positive True negative Analytical sensitivity Analytical specificity Nucleic acid amplification techniques (NAT) Rapid test Robustness Whole system failure rate Confirmation assay Virus typing assay Sero-conversion HIV samples Early sero-conversion HIV samples 3.COMMON TECHNICAL SPECIFICATIONS (CTS) FOR PRODUCTS REFERRED TO IN ANNEX...3.1.CTS for performance evaluation of reagents and reagent products for...General principles 3.1.1.Devices which detect virus infections shall meet the requirements for...3.1.2.Devices intended by the manufacturer for testing body fluids other...3.1.3.Devices intended by the manufacturer for self-test, i.e. home use,...3.1.4.All performance evaluations shall be carried out in direct comparison...3.1.5.If discrepant test results are identified as part of an...3.1.6.Performance evaluations shall be performed on a population equivalent to...3.1.7.Positive specimens used in the performance evaluation shall be selected...3.1.8.Sensitivity with true positives and sero-conversion samples shall be evaluated...3.1.9.Performance evaluation of screening assays shall include 25 positive (if...3.1.10.Negative specimens used in a performance evaluation shall be defined...3.1.11.For performance evaluations for screening assays (Table 1) blood donor...3.1.12.Devices shall have a specificity of at least 99,5 % on...3.1.13.Devices shall be evaluated to establish the effect of potential...3.1.14.For devices intended by the manufacturer to be used with...3.1.15.For devices intended for use with plasma the performance evaluation...3.1.16.As part of the required risk analysis the whole system...3.1.17.If a new in vitro diagnostic medical device belonging to...3.2.Additional requirements for HIV and HCV antigen and antibody combined...3.2.1.HIV antigen and antibody combined tests intended for the detection...3.2.2.Hepatitis C virus (HCV) antigen and antibody combined tests intended...3.3.Additional requirements for nucleic acid amplification techniques (NAT) 3.3.1.For target sequence amplification assays, a functionality control for each...3.3.2.The analytical sensitivity or detection limit for NAT assays shall...3.3.2a.Qualitative HIV NAT assays intended to be used to detect...3.3.2b.Qualitative HIV NAT assays, other than virus typing assays, shall...3.3.3.Genotype detection shall be demonstrated by appropriate primer or probe...3.3.4.Results of quantitative NAT assays shall be traceable to international...3.3.5.NAT assays may be used to detect virus in antibody...3.3.6.For investigation of potential carry-over, at least five runs with...3.3.7.The whole system failure rate leading to false-negative results shall...3.4.CTS for the manufacturer’s release testing of reagents and reagent...3.4.1.The manufacturer’s release testing criteria shall ensure that every batch...3.4.2.The manufacturer’s batch release testing for screening assays shall include...3.5.CTS for performance evaluation of reagents and reagent products for...3.5.1.All performance evaluations shall be carried out in direct comparison...3.5.2.If discrepant test results are identified as part of an...3.5.3.Performance evaluations shall be performed on a population equivalent to...3.5.4.Positive specimens used in the performance evaluation shall be selected...3.5.5.Devices shall be evaluated to establish the effect of potential...3.5.6.For devices intended for use with plasma the performance evaluation...3.6.CTS for the manufacturer’s release testing of reagents and reagent...3.6.1.The manufacturer’s release testing criteria shall ensure that every batch...3.6.2.Requirements for manufacturers batch release testing are outlined in Table...3.7.CTS for Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening...Acceptance criteria: Qualifications: Table 10 Batch release criteria for reagents and reagent products to determine...Specificity testing requirements on each reagent 1. Test reagents Only...1.Test reagents Acceptance criteria: 2.Control materials (red cells)

Commission Decision

of 7 May 2002

on common technical specifications for in vitro-diagnostic medical devices

(notified under document number C(2002) 1344)

(Text with EEA relevance)

(2002/364/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices1, and in particular the second subparagraph of Article 5(3) thereof,

Whereas:

(1)

Directive 98/79/EC sets out the essential requirements that in vitro diagnostic medical devices must meet when they are placed on the market and conformity with harmonised standards provides a presumption of conformity with the relevant essential requirements.

(2)

By way of exception to these general principles, the drawing up of common technical specifications takes account of a current practice in some Member States whereby for selected devices mainly used for the evaluation of the safety of blood supply and of organ donation, such specifications are adopted by the public authorities. These common technical specifications can be used for performance evaluation and re-evaluation.

(3)

Scientific experts from various interested parties have been involved in the drafting of the common technical specifications.

(4)

Directive 98/79/EC provides that Member States are to presume compliance with the essential requirements in respect of devices designed and manufactured in conformity with common technical specifications drawn up for certain devices in the highest risk category. These specifications are to establish appropriate performance evaluation and re-evaluation criteria, batch release criteria, reference methods and reference materials.

(5)

Manufacturers are, as a general rule, to be required to comply with the common technical specifications. If, for duly justified reasons, manufacturers do not comply with those specifications they must adopt solutions of a level at least equivalent thereto.

(6)

The measures provided for in this Decision are in accordance with the opinion of the committee set up by Article 6(2) of Council Directive 90/385/EEC2,

HAS ADOPTED THIS DECISION: