{
  "url": "https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-3.1/division-1/division-3.1.8",
  "json_url": "https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-3.1/division-1/division-3.1.8.json",
  "legislation": "eudn/2002/364",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2002-364",
  "path": "annex/division/3/division/3.1/division/1/division/3.1.8",
  "kind": "division",
  "number": "3.1.8",
  "heading": null,
  "text": "Sensitivity with true positives and sero-conversion samples shall be evaluated as follows:\n3.1.8.1.Diagnostic test sensitivity during sero-conversion has to represent the state of the art. Whether further testing of the same or additional sero-conversion panels is conducted by the approved body or by the manufacturer the results shall confirm the initial performance evaluation data (see Table 1). Sero-conversion panels should start with a negative bleed(s) and should have narrow bleeding intervals.\n3.1.8.2.For blood screening devices (with the exception of HBsAg and anti-HBc tests), all true positive samples shall be identified as positive by the device to be UK or CE marked, (Table 1). For HBsAg and anti-HBc tests the new device shall have an overall performance at least equivalent to that of the established device (see 3.1.4).\n3.1.8.3.Regarding HIV tests:\nall sero-conversion HIV samples shall be identified as positive, and\nat least 40 early sero-conversion HIV samples shall be tested. Results should conform to the state of the art.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2009) 9464) (Text with EEA relevance) (2009/886/EC)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Annex point 3.1.8 substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 3(b)(ii)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Annex point 3.1.8 substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 3(b)(i)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2002/364/annex/division/3/division/3.1/division/1/division/3.1.8",
    "retrieved_at": "2026-11-01T15:18:33.780237+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}