{
  "url": "https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023/regulation-43",
  "json_url": "https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023/regulation-43.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/43",
  "kind": "regulation",
  "number": "43",
  "heading": "Amendment to Schedule 2 (fees in connection with the designation of notified bodies)",
  "text": "In Schedule 2—\n(a) the first column (application) in Table 1 (application fees) is amended as follows—\n(i) at the end of entry 1 insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”;\n(ii) in entry 2, after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”;\n(iii) at the end of entry 3 insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”;\n(iv) in entry 4—\n(aa) after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”;\n(bb) after “an Annex” insert “to Regulation (EU) 2017/745 or Regulation (EU) 2017/746”;\n(v) in entry 5, after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”;\n(b) the first column (activity) in Table 2 (fees for assessments and reviews) is amended as follows—\n(i) in entry 1—\n(aa) after “Article 39(4)” insert “of Regulation (EU) 2017/745 or Article 35(4) of Regulation (EU) 2017/746”;\n(bb) after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”;\n(cc) at the end insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”;\n(ii) at the end of entry 2 insert “of Regulation (EU) 2017/745 or Article 40(4) of Regulation (EU) 2017/746”;\n(iii) at the end of entry 3 insert “of Regulation (EU) 2017/745 or Article 40(5) of Regulation (EU) 2017/746”;\n(iv) in entry 5—\n(aa) after “Article 44(7)” insert “of Regulation (EU) 2017/745 or Article 40(7) of Regulation (EU) 2017/746”;\n(bb) in sub-paragraph (b), after “Regulation (EU) 2017/745” insert “, or Regulation (EU) 2017/746”.",
  "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/43",
    "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."
}