{
  "url": "https://openlegislation.uk/draft-medical-devices-amendment-great-britain-regulations-2023/regulation-6",
  "json_url": "https://openlegislation.uk/draft-medical-devices-amendment-great-britain-regulations-2023/regulation-6.json",
  "legislation": "ukdsi/2023/9780348247657",
  "legislation_title": "The Medical Devices (Amendment) (Great Britain) Regulations 2023",
  "legislation_url": "https://openlegislation.uk/draft-medical-devices-amendment-great-britain-regulations-2023",
  "path": "regulation/6",
  "kind": "regulation",
  "number": "6",
  "heading": "Amendments to regulation 19B (obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42)",
  "text": "(1) Regulation 19B is amended as follows.\n(2) In paragraph (1)(a)—\n(a) after “Directive 93/42” insert “as it had effect on 25 May 2021”;\n(b) omit “as amended from time to time”.\n(3) In paragraph (3)—\n(a) at the beginning insert “Subject to paragraph (3A),”;\n(b) after sub-paragraph (b) insert—\n“(ba) ensures that any certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;”;\n(c) in sub-paragraph (f) for “draws up” substitute “has drawn up before 26 May 2021”.\n(4) After paragraph (3) insert—\n“(3A) Paragraph (3) only applies to a class I device under the Directive if—\n(a) the conformity assessment procedure under Article 11 required the involvement of a notified body; or\n(b) the conformity assessment procedure for that device under Article 52 of Regulation (EU) 2017/745 would require the involvement of a notified body (if it were to be assessed under that regulation).”.\n(5) In paragraph (7)—\n(a) after sub-paragraph (b) insert—\n“(ba) ensures that any certificate in relation to the system or procedure pack or a device within it that was issued by a notified body under the Directive is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;\n(bb) ensures that the declarations required by Article 12 were drawn up before 26 May 2021;”;\n(b) at the end of sub-paragraph (c) omit “and”;\n(c) at the end of sub-paragraph (d) for “English.” substitute “English; and”;\n(d) after sub-paragraph (d) insert—\n“(e) ensures that the system or procedure pack does not contain a class I device under the Directive for which—\n(i) the conformity assessment procedure under Article 11 did not require the involvement of a notified body; and\n(ii) the conformity assessment procedure under Article 52 of Regulation (EU) 2017/745 would not require the involvement of a notifed body (if it were to be assessed under that regulation).”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Regulation 19B was inserted by S.I. 2019/791."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2023/9780348247657/regulation/6",
    "retrieved_at": "2026-10-30T14:43:27.112341+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."
}