{
  "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/schedule-2",
  "json_url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/schedule-2.json",
  "legislation": "ukdsi/2021/9780348224740",
  "legislation_title": "The Medical Devices (Northern Ireland Protocol) Regulations 2021",
  "legislation_url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021",
  "path": "schedule/2",
  "kind": "schedule",
  "number": "2",
  "heading": "Fees in connection with the designation of notified bodies",
  "text": "Table 1\nApplication fees\nApplication\nFee\n1. For initial designation submitted under Article 38\n£8,252\n2. For initial designation re-submitted under Article 38 where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application\n£2,063\n3. For reassessment under Article 44(10)\n£8,252\n4. For an extension of the scope of the designation under Article 46(1)\n£6,504\nTable 2\nFees for assessments and reviews\nActivity\nFee\n1. On-site assessment under Article 39(4) in connection with an application for initial designation under Article 38, or an application for reassessment under Article 44(10)\n£15,904\n2. On-site audit as part of an annual reassessment under Article 44(4)\n£10,160\n3. Observed audit of notified body personnel under Article 44(5)\n£4,404\n4. On-site assessment of a subsidiary\n£3,876\n5. ‘For-cause’ review under Article 44(7) to—\n(a) review assessments by the notified body, including clinical evaluation documentation;\n(b) otherwise verify compliance with the requirements of Regulation (EU) 2017/745 or address a particular issue\n(a) £2,586\n(b) £3,876",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2021/9780348224740/schedule/2",
    "retrieved_at": "2026-10-30T14:46:58.636532+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."
}