{
  "url": "https://openlegislation.uk/medical-devices-fees-amendment-regulations-2017/note",
  "json_url": "https://openlegislation.uk/medical-devices-fees-amendment-regulations-2017/note.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": "note",
  "kind": "note",
  "number": null,
  "heading": "Explanatory note",
  "text": "(This note is not part of the Regulations)\nThese Regulations make amendments to the Medical Devices Regulations 2002 (the 2002 Regulations).\nThe 2002 Regulations implement Directive 90/385/EEC on the approximation of laws of Member States relating to active implantable devices, Directive 93/42/EEC concerning medical devices and Directive 98/79/EC on in vitro diagnostic devices by setting out a scheme for regulating the placing on the market and putting into service of medical devices in the United Kingdom.\nPart VI of the 2002 Regulations sets out the fees that are payable under the scheme.\nRegulations 2, 3(1) to (5) and 4 increase existing fees payable to the Secretary of State in connection with the registration of devices and the designation of notified bodies.\nRegulation 3(6) introduces new fees for work undertaken by the Secretary of State under Commission Implementing Regulation (EU) No 920/2013 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. The new fees relate to applications for re-designation by notified bodies and inspections carried out by the Secretary of State in respect of those notified bodies.\nRegulation 3(6) also introduces a new fee for work undertaken by the Secretary of State under Commission Implementing Regulation (EU) No 722/2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin. The new fee relates to the submission of summary evaluation reports by notified bodies to the Secretary of State where a notified body is assessing a device manufactured using animal tissue.\nRegulation 5 introduces a new fee in connection with amendments made to clinical investigation notices submitted to the Secretary of State.\nAn impact assessment of the effects that this instrument will have on the costs of business and the voluntary sector is available from the Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace Road, London, SW1W 9SZ and is published with the explanatory memorandum alongside the instrument on www.legislation.gov.uk.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2017/207/note",
    "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."
}