{
  "url": "https://openlegislation.uk/eu-directive-1993-42/annex-I/division-II/division-9/division-9.2",
  "json_url": "https://openlegislation.uk/eu-directive-1993-42/annex-I/division-II/division-9/division-9.2.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/II/division/9/division/9.2",
  "kind": "division",
  "number": "9.2",
  "heading": null,
  "text": "Devices must be designed and manufactured in such a way as to remove or minimize as far as is possible:\nthe risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features,\nrisks connected with reasonably foreseeable environmental conditions, such as magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature or variations in pressure and acceleration,\nthe risks of reciprocal interference with other devices normally used in the investigations or for the treatment given,\nrisks arising where maintenance or calibration are not possible (as with implants), from ageing of materials used or loss of accuracy of any measuring or control mechanism.",
  "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/II/division/9/division/9.2",
    "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."
}