{
  "url": "https://openlegislation.uk/medicines-and-medical-devices-act-2021/schedule-3/paragraph-2",
  "json_url": "https://openlegislation.uk/medicines-and-medical-devices-act-2021/schedule-3/paragraph-2.json",
  "legislation": "ukpga/2021/3",
  "legislation_title": "Medicines and Medical Devices Act 2021",
  "legislation_url": "https://openlegislation.uk/medicines-and-medical-devices-act-2021",
  "path": "schedule/3/paragraph/2",
  "kind": "paragraph",
  "number": "2",
  "heading": null,
  "text": "In the Medical Devices Regulations 2002 (S.I. 2002/618), after the last Schedule insert, with the appropriate number, the following Schedule—\n“SCHEDULE\nProvisions breach of which is an offence under regulation 60A\nRegulation 60A\nThe regulations referred to in regulation 60A(1) are—\nRegulation\nDescription\n8(1), (2)\nEssential requirements for general medical devices\n10(1) to (5)\nCE marking of general medical devices\n11\nCE marking of general medical devices within scope of more than one Directive\n13(1) to (4)\nProcedures for affixing a CE marking to general medical devices\n14(1), (2), (5)\nProcedures for systems and procedure packs, and for devices to be sterilised before use\n15\nProcedures for custom-made general medical devices\n16(1), (4), (7), (10)\nProcedures for general medical devices for clinical investigation\n17(1), (2)\nManufacturers etc and conformity assessment procedures for general medical devices\n19\nRegistration of persons placing general medical devices on the market\n22\nEssential requirements for active implantable medical devices\n24\nCE marking of active implantable medical devices\n25\nCE marking of active implantable medical devices within scope of more than one Directive\n27\nProcedures for affixing a CE marking to active implantable medical devices\n28\nProcedures for custom-made active implantable medical devices\n29(1), (3), (6), (7), (9)\nProcedures for active implantable medical devices for clinical investigations\n30(1)\nManufacturers etc and conformity assessment procedures for active implantable medical devices\n34\nEssential requirements for in vitro diagnostic medical devices\n36(1) to (5)\nCE marking of in vitro diagnostic medical devices\n37\nCE marking of in vitro diagnostic medical devices within scope of more than one Directive\n38\nIn vitro diagnostic medical devices not ready for use\n40\nProcedures for affixing a CE marking to in vitro diagnostic medical devices\n41(1), (2), (3)\nManufacturers etc and conformity assessment procedures for in vitro diagnostic medical devices\n43\nDevices for performance evaluation\n44\nRegistration of manufacturers etc of in vitro diagnostic medical devices and devices for performance evaluation\n50(1)(a) and (b), (2), (3)\nProducts incorrectly marked with a notified body or conformity assessment body number\n51(1), (2)\nProducts incorrectly marked with a CE marking\n”",
  "extent": null,
  "status": "prospective",
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukpga/2021/3/schedule/3/paragraph/2",
    "retrieved_at": "2026-10-29T08:59:13.676472+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."
}