{
  "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021",
  "json_url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021.json",
  "id": "ukdsi/2021/9780348224740",
  "title": "The Medical Devices (Northern Ireland Protocol) Regulations 2021",
  "short_title": "Medical Devices (Northern Ireland Protocol) 2021",
  "long_title": "These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017) (“Regulation (EU) 2017/745”). Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement between the United Kingdom and the European Union (“the Protocol”) provides that the EU law listed in Annex 2 to the Protocol will apply to and in the UK, in respect of Northern Ireland. Regulation (EU) 2017/745 is listed in Annex 2 and applied from 26 May 2021. Section 7A of the European Union (Withdrawal) Act 2018 gives effect to Regulation (EU) 2017/745 in domestic law.",
  "citation": "Draft 2021, ISBN 9780348224740",
  "type": "ukdsi",
  "year": "2021",
  "number": "9780348224740",
  "version": "current",
  "date": null,
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "part/1",
      "kind": "part",
      "number": "1",
      "heading": "Preliminary",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
      "kind": "regulation",
      "number": "1",
      "heading": "Citation and commencement",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-1",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/2",
      "kind": "regulation",
      "number": "2",
      "heading": "Extent and application",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-2",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-3",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/4",
      "kind": "regulation",
      "number": "4",
      "heading": "Scope",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-4",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "part/2",
      "kind": "part",
      "number": "2",
      "heading": "Making available on the market and putting into service under Regulation (EU) 2017/745",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/5",
      "kind": "regulation",
      "number": "5",
      "heading": "Reprocessing of single-use devices",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-5",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/6",
      "kind": "regulation",
      "number": "6",
      "heading": "Requirement on health institutions to provide information relating to implanted devices",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-6",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/7",
      "kind": "regulation",
      "number": "7",
      "heading": "Registration of custom-made devices",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-7",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/8",
      "kind": "regulation",
      "number": "8",
      "heading": "Certificates of free sale - fee",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-8",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/9",
      "kind": "regulation",
      "number": "9",
      "heading": "Retention of documentation relating to conformity assessments and custom-made devices",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-9",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/10",
      "kind": "regulation",
      "number": "10",
      "heading": "UK(NI) indication",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-10",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "part/3",
      "kind": "part",
      "number": "3",
      "heading": "Clinical investigations under Regulation (EU) 2017/745",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/11",
      "kind": "regulation",
      "number": "11",
      "heading": "Ethical review of clinical investigations",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-11",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/12",
      "kind": "regulation",
      "number": "12",
      "heading": "Prior authorisation of clinical investigations by the Secretary of State",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-12",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/13",
      "kind": "regulation",
      "number": "13",
      "heading": "Arbitration following the refusal of a clinical investigation application",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-13",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/14",
      "kind": "regulation",
      "number": "14",
      "heading": "Damage compensation in relation to clinical investigations",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-14",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/15",
      "kind": "regulation",
      "number": "15",
      "heading": "Retention of documentation relating to clinical investigations",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-15",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/16",
      "kind": "regulation",
      "number": "16",
      "heading": "Clinical investigation fees",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-16",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/17",
      "kind": "regulation",
      "number": "17",
      "heading": "Clinical investigations not carried out for a purpose specified in Article 62(1)",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-17",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "part/4",
      "kind": "part",
      "number": "4",
      "heading": "Notified bodies designated under Regulation (EU) 2017/745",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/18",
      "kind": "regulation",
      "number": "18",
      "heading": "Notified bodies",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-18",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/19",
      "kind": "regulation",
      "number": "19",
      "heading": "Fees payable in connection with the designation of notified bodies",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-19",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "part/5",
      "kind": "part",
      "number": "5",
      "heading": "General provision about language requirements and fees",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/20",
      "kind": "regulation",
      "number": "20",
      "heading": "Language requirements",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-20",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/21",
      "kind": "regulation",
      "number": "21",
      "heading": "Unpaid fees",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-21",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/22",
      "kind": "regulation",
      "number": "22",
      "heading": "Waivers, reductions and refunds",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-22",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "part/6",
      "kind": "part",
      "number": "6",
      "heading": "Enforcement",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/23",
      "kind": "regulation",
      "number": "23",
      "heading": "Offence of breaching certain provisions",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-23",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/24",
      "kind": "regulation",
      "number": "24",
      "heading": "Defence of due diligence",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-24",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/25",
      "kind": "regulation",
      "number": "25",
      "heading": "Offences by bodies corporate",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-25",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/26",
      "kind": "regulation",
      "number": "26",
      "heading": "Enforcement",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-26",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "part/7",
      "kind": "part",
      "number": "7",
      "heading": "Amendment of primary legislation",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/27",
      "kind": "regulation",
      "number": "27",
      "heading": "Investigatory powers under the Consumer Rights Act 2015",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-27",
      "extent": null,
      "status": null,
      "parent": "part/7"
    },
    {
      "path": "regulation/28",
      "kind": "regulation",
      "number": "28",
      "heading": "Amendment of the Medicines and Medical Devices Act 2021",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-28",
      "extent": null,
      "status": null,
      "parent": "part/7"
    },
    {
      "path": "part/8",
      "kind": "part",
      "number": "8",
      "heading": "Amendment of the Medical Devices Regulations 2002",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/29",
      "kind": "regulation",
      "number": "29",
      "heading": "Amendments to the Medical Devices Regulations 2002",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-29",
      "extent": null,
      "status": null,
      "parent": "part/8"
    },
    {
      "path": "regulation/30",
      "kind": "regulation",
      "number": "30",
      "heading": "Amendment of regulation 2 (interpretation)",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-30",
      "extent": null,
      "status": null,
      "parent": "part/8"
    },
    {
      "path": "regulation/31",
      "kind": "regulation",
      "number": "31",
      "heading": "Amendment of regulation 2A (medical devices which are qualifying Northern Ireland goods)",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-31",
      "extent": null,
      "status": null,
      "parent": "part/8"
    },
    {
      "path": "regulation/32",
      "kind": "regulation",
      "number": "32",
      "heading": "Revocation and transitional provision",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-32",
      "extent": null,
      "status": null,
      "parent": "part/8"
    },
    {
      "path": "regulation/33",
      "kind": "regulation",
      "number": "33",
      "heading": "Amendment of regulation 10A (UK(NI) indication: general medical devices)",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-33",
      "extent": null,
      "status": null,
      "parent": "part/8"
    },
    {
      "path": "regulation/34",
      "kind": "regulation",
      "number": "34",
      "heading": "Amendment of regulation 19 (registration of persons placing general medical devices on the market)",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-34",
      "extent": null,
      "status": null,
      "parent": "part/8"
    },
    {
      "path": "regulation/35",
      "kind": "regulation",
      "number": "35",
      "heading": "Amendment of regulation 21B (registration of persons placing active implantable medical devices on the market)",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-35",
      "extent": null,
      "status": null,
      "parent": "part/8"
    },
    {
      "path": "regulation/36",
      "kind": "regulation",
      "number": "36",
      "heading": "Amendment of regulation 24A (UK(NI) indication: active implantable medical devices)",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-36",
      "extent": null,
      "status": null,
      "parent": "part/8"
    },
    {
      "path": "regulation/37",
      "kind": "regulation",
      "number": "37",
      "heading": "Amendment of regulation 36A (UK(NI) indication: in vitro diagnostic medical devices)",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-37",
      "extent": null,
      "status": null,
      "parent": "part/8"
    },
    {
      "path": "part/9",
      "kind": "part",
      "number": "9",
      "heading": "Amendments of other secondary legislation",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/38",
      "kind": "regulation",
      "number": "38",
      "heading": "Amendment of the Blood Safety and Quality Regulations 2005",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-38",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "regulation/39",
      "kind": "regulation",
      "number": "39",
      "heading": "Amendment of the Human Tissue (Quality and Safety for Human Application) Regulations 2007",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-39",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "regulation/40",
      "kind": "regulation",
      "number": "40",
      "heading": "Amendment of the Legislative and Regulatory Reform (Regulatory Functions) Order 2007",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-40",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "regulation/41",
      "kind": "regulation",
      "number": "41",
      "heading": "Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-41",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "regulation/42",
      "kind": "regulation",
      "number": "42",
      "heading": "Amendment of the Economic Growth (Regulatory Functions) Order 2017",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-42",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "regulation/43",
      "kind": "regulation",
      "number": "43",
      "heading": "Amendment of the Market Surveillance (Northern Ireland) Regulations 2021",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-43",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/signature",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/1",
      "kind": "schedule",
      "number": "1",
      "heading": "Fees for clinical investigations",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/schedule-1",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/2",
      "kind": "schedule",
      "number": "2",
      "heading": "Fees in connection with the designation of notified bodies",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/schedule-2",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/3",
      "kind": "schedule",
      "number": "3",
      "heading": "Provisions breach of which is an offence under regulation 23",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/schedule-3",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "note",
      "kind": "note",
      "number": null,
      "heading": "Explanatory note",
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/note",
      "extent": null,
      "status": null,
      "parent": null
    }
  ],
  "has_text": true,
  "pdfs": [
    {
      "title": "Printed copy",
      "main": true,
      "language": null,
      "date": "2021-06-16",
      "size": 122794,
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/pdf/ukdsi_9780348224740_en.pdf",
      "source_url": "https://www.legislation.gov.uk/ukdsi/2021/9780348224740/pdfs/ukdsi_9780348224740_en.pdf"
    },
    {
      "title": "UK Draft Explanatory Memorandum",
      "main": false,
      "language": null,
      "date": "2021-06-16",
      "size": 72756,
      "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/pdf/ukdsiem_9780348224740_en.pdf",
      "source_url": "https://www.legislation.gov.uk/ukdsi/2021/9780348224740/pdfs/ukdsiem_9780348224740_en.pdf"
    }
  ],
  "outstanding_effects": [],
  "made_under": [
    {
      "id": "ukpga/2018/16",
      "title": "European Union (Withdrawal) Act 2018",
      "url": "https://openlegislation.uk/european-union-withdrawal-act-2018",
      "provisions": [
        "section/8C",
        "schedule/4/paragraph/1",
        "schedule/7/paragraph/21"
      ]
    }
  ],
  "changes_made_to": 0,
  "changes_made_to_url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/changes.json",
  "changes_made_by": 0,
  "changes_made_by_url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2021/9780348224740",
    "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."
}