{
  "url": "https://openlegislation.uk/eu-directive-1993-42/annex-I/division-I/division-2",
  "json_url": "https://openlegislation.uk/eu-directive-1993-42/annex-I/division-I/division-2.json",
  "legislation": "eudr/1993/42",
  "legislation_title": "Council Directive 93/42/EEC of 14 June 1993 concerning medical devices",
  "legislation_url": "https://openlegislation.uk/eu-directive-1993-42",
  "path": "annex/I/division/I/division/2",
  "kind": "division",
  "number": "2",
  "heading": null,
  "text": "The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.\nIn selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:\neliminate or reduce risks as far as possible (inherently safe design and construction),\nwhere appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,\ninform users of the residual risks due to any shortcomings of the protection measures adopted.",
  "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/1993/42/annex/I/division/I/division/2",
    "retrieved_at": "2026-11-01T15:23:18.816106+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."
}