11.12.2008 Official Journal of the European Union L 333/5 (Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory) DECISIONS COMMISSION COMMISSION DECISION of 2 December 2008 on the application of Article 8 of Directive 98/79/EC of the European Parliament and of the Council (notified under document number C(2008) 7378) (Only the Portuguese text is authentic) (2008/932[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 devices ('), and in particular Article 8 thereof, Whereas: (1) The Portuguese medical device authority Infarmed has, by letter of 29 July 2005 (3 addressed to the Italian company Medical Biological Service SRL (hereafter MBS), forbidden the marketing of their HIV in-vitro diag- nostic test kit ‘HIV 1 & 2 Ab’ (hereafter the HIV test). Infarmed also obliged the Portuguese distributor Pres- tifarma Lda to recall the product on behalf of MBS. By letter of 1 September 2005 (*) Infarmed notified these measures under Article 13 of Directive 98/79/EC. As justification for their measure Portugal referred to the German Paul-Ehrlich-Institut’s health surveillance report ‘NCAR DE-2005-07-30" (PEI Case No PEI0026/05). A subsequent exchange of letters clarified that the NCAR reference was misquoted and that the correct NCAR report number was DE-2005-07-07-30 and that this () OJ L 331, 7.12.1998, p. 1. () DGREE/VPS[086/05 — Case No 9.5.1 — 329/2005. () DGREE/VPS/094/05. report is identical to the NCAR report DE-2005-07-27- 30. The NCAR report DE-2005-07-07-30 states that, shortly after an HIV infection, the HIV test needs 10 to 18 days more than comparable tests to detect the infection (low early sero-conversion sensitivity). For the same reason, the Slovak Medical University had, in its test report of 28 October 2004 (%), recommended the Slovak notified body EVPU not to certify the HIV test. The test did thus not fulfil the requirement of being conform to the ‘state of the art’ in the meaning of Annex I (Essential requirements) section A.2 of Directive 98/79/EC and section 3.1.8, third sentence, of the Common technical specifications for in-vitro diagnostic medical devices annexed to Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in-vitro diagnostic medical devices (°). Moreover, as stated by the Paul-Ehrlich-Institut in its letter to the German Ministry of Health of 12 December 2005 (), the documentation made available by the manufacturer shows that the HIV test did not detect all true positive samples, as required by 3.1.8, first sentence, of the Common technical specifi- cations. This failure has never been explained by the manufacturer or his notified body as required by paragraph 3.1.5 of the Common technical specifications. Thus the HIV test does not fulfil sections 3.1.8, first sentence, and 3.1.5 of the Common technical specifi- cations. (*) Test report No E-650/04 208600. () O L 131, 16.5.2002, p. 17. (°) Reference No A2.