{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-VIII/division-2",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-VIII/division-2.json",
  "legislation": "eudr/1998/79",
  "legislation_title": "Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices",
  "legislation_url": "https://openlegislation.uk/eu-directive-1998-79",
  "path": "annex/VIII/division/2",
  "kind": "division",
  "number": "2",
  "heading": null,
  "text": "The statement shall contain the following information:\ndata allowing identification of the device in question,\nan evaluation plan stating in particular the purpose, scientific, technical or medical grounds, scope of the evaluation and number of devices concerned,\nthe list of laboratories or other institutions taking part in the evaluation study,\nthe starting date and scheduled duration for the evaluations and, in the case of devices for self-testing, the location and number of lay persons involved,\na statement that the device in question conforms to the requirements of the Directive, apart from the aspects covered by the evaluation and apart from those specifically itemised in the statement, and that every precaution has been taken to protect the health and safety of the patient, user and other persons.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1998/79/annex/VIII/division/2",
    "retrieved_at": "2026-11-01T15:23:06.143766+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."
}