{
  "url": "https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023/regulation-44",
  "json_url": "https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023/regulation-44.json",
  "legislation": "ukdsi/2023/9780348253696",
  "legislation_title": "The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023",
  "legislation_url": "https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023",
  "path": "regulation/44",
  "kind": "regulation",
  "number": "44",
  "heading": "Amendment to Schedule 3 (provisions breach of which is an offence under regulation 23)",
  "text": "In Schedule 3—\n(a) for Table 1 substitute—\n“\nTable 1\nRegulation\nTitle of the regulation\n5\nReprocessing of single-use devices\n6\nRequirement on health institutions relating to implanted devices\n7\nProvision of information relating to custom-made devices\n9\nRetention of documentation relating to conformity assessments and custom-made devices\n10\nUK(NI) indication under Regulation (EU) 2017/745\n10B\nRetention of documentation relating to conformity assessments\n10C\nUK(NI) indication under Regulation (EU) 2017/746\n11\nEthical review of clinical investigations\n12(1)\nPrior authorisation of clinical investigations by the Secretary of State\n14\nDamage compensation in relation to clinical investigations\n15\nRetention of documentation relating to clinical investigations\n17C\nEthical review of performance studies\n17E\nDamage compensation in relation to performance studies\n17F\nRetention of documentation relating to performance studies\n”\n(b) in Table 2—\n(i) for “general obligations on manufacturers” substitute “general obligations of manufacturers”;\n(ii) for “32(1), (2)” substitute “32(1) (except the second sentence of the third sub-paragraph), (2)”;\n(iii) for “86” substitute “86 (except the second and third sentences of paragraph (2))”;\n(c) after Table 2 insert—\n“\nTable 3\nArticle\nTitle of the article\n5(1) to (3), (5)\nPlacing on the market and putting into service\n6(1) to (3)\nDistance sales\n7\nClaims\n9(3)\nCommon specifications\n10 (except the second, third or fourth sub-paragraphs of paragraph 13)\nGeneral obligations of manufacturers\n11(1), (3), (6)\nAuthorised representative\n12\nChange of authorised representative\n13\nGeneral obligations of importers\n14\nGeneral obligations of distributors\n15\nPerson responsible for regulatory compliance\n16(3), (4)\nCases in which obligations of manufacturers apply to importers, distributors or other persons\n20(1)\nParts and components\n22\nIdentification within the supply chain\n29(1) (except the second sentence of the third sub-paragraph), (2)\nSummary of safety and performance\n48(1), (2), (3) (except the third sub-paragraph), (4) (except the second sub-paragraph), (7) (except the third sub-paragraph), (8) (except the second sub-paragraph), (9) and (10)\nConformity assessment procedures\n49(3)\nInvolvement of notified bodies in conformity assessment procedures\n53(1)\nVoluntary change of notified body\n57\nGeneral requirements regarding performance studies\n58(1), (2), (4) (except the second sub-paragraph), (5), (6) and (8)\nAdditional requirements for certain performance studies\n79\nPost-market surveillance plan\n80\nPost-market surveillance report\n81 (except the second and third sentences of paragraph (2))\nPeriodic safety update report\n84(1), (3) (except the first sub-paragraph), (5) and (8)\nAnalysis of serious incidents and field safety corrective actions\n89 (only the final paragraph)\nEvaluation of devices suspected of presenting an unacceptable risk or other non-compliance\n”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2023/9780348253696/regulation/44",
    "retrieved_at": "2026-10-30T14:42:17.468953+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."
}