{
  "url": "https://openlegislation.uk/medical-devices-fees-amendment-regulations-2017/regulation-3",
  "json_url": "https://openlegislation.uk/medical-devices-fees-amendment-regulations-2017/regulation-3.json",
  "legislation": "uksi/2017/207",
  "legislation_title": "The Medical Devices (Fees Amendment) Regulations 2017",
  "legislation_url": "https://openlegislation.uk/medical-devices-fees-amendment-regulations-2017",
  "path": "regulation/3",
  "kind": "regulation",
  "number": "3",
  "heading": "Amendment of regulation 54 of the 2002 Regulations",
  "text": "(1) Regulation 54 of the 2002 Regulations (fees payable in connection with the designation etc. of UK notified bodies) is amended as follows.\n(2) In paragraph (1)—\n(a) in sub-paragraph (a), for “£960” substitute “£2,063”; and\n(b) in sub-paragraph (b), for “£3,840”substitute “£8,252”.\n(3) In paragraph (2), for “£1,880” substitute “£6,504”.\n(4) In paragraph (3)—\n(a) in sub-paragraph (a), for “£4,670” substitute “£15,904”;\n(b) in sub-paragraph (b), for each of “£7,670”, “£5,760” and “£3,840” substitute “£10,160”; and\n(c) in sub-paragraph (c), for “£3,840” substitute “£4,404”.\n(5) In paragraph (3A)—\n(a) in sub-paragraph (a)(i), for “£271” substitute “£361.20”; and\n(b) in sub-paragraph (a)(ii), for “£75.24” substitute “£90.30”.\n(6) After paragraph (3B) insert—\n“(3C) A UK notified body that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation (EU) No 920/2013 shall pay to the Secretary of State—\n(a) a fee of £8,252 in respect of the application; and\n(b) where an audit is carried out in connection with the application, a fee of £15,904 in respect of the audit.\n(3D) Where the Secretary of State conducts an assessment of a UK notified body pursuant to article 5 of Regulation (EU) No 920/2013, the UK notified body shall pay to the Secretary of State—\n(a) if the assessment relates to the UK notified body’s assessment of clinical data only, a fee of £2,586; or\n(b) in any other case, a fee of £3,876.\n(3E) A UK notified body that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation (EU) No 722/2012 shall pay to the Secretary of State a fee of £532.”.\n(7) In paragraph (4)—\n(a) in sub-paragraph (a)—\n(i) for “regulation 45(1) or” substitute “regulation 45(1),”,\n(ii) after “regulation 45(4)” insert “, a renewal under Regulation (EU) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation (EU) No 722/2012”, and\n(iii) in paragraphs (i) and (ii), after “application” insert “or submission”; and\n(b) in sub-paragraph (b), after “regulation 45(7)” insert “or an audit or assessment pursuant to Regulation (EU) No 920/2013”.\n(8) After paragraph (4), insert—\n“(5) In this regulation, “Regulation (EU) No 920/2013” means Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No L 253 25.9.2013 p.8."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2017/207/regulation/3",
    "retrieved_at": "2026-10-28T23:14:41.325576+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."
}