{ "url": "https://openlegislation.uk/eu-regulation-2017-745", "json_url": "https://openlegislation.uk/eu-regulation-2017-745.json", "id": "eur/2017/745", "title": "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 (Text with EEA relevance) (revoked)", "short_title": "Regulation (EU) 2017/745 on medical devices", "long_title": "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 (Text with EEA relevance)", "citation": "EU Regulation 2017/745", "type": "eur", "year": "2017", "number": "745", "version": "current", "date": "2017-04-05", "revised": false, "valid_from": null, "extent": "E+W+S+N.I.", "unapplied_effects": 0, "provisions": [ { "path": "introduction", "kind": "introduction", "number": null, "heading": "Introductory text", "url": "https://openlegislation.uk/eu-regulation-2017-745/introduction", "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "chapter/I", "kind": "chapter", "number": "I", "heading": "SCOPE AND DEFINITIONS", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "article/1", "kind": "article", "number": "1", "heading": "Subject matter and scope", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/I" }, { "path": "article/2", "kind": "article", "number": "2", "heading": "Definitions", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-2", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/I" }, { "path": "article/3", "kind": "article", "number": "3", "heading": "Amendment of certain definitions", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-3", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/I" }, { "path": "article/4", "kind": "article", "number": "4", "heading": "Regulatory status of products", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-4", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/I" }, { "path": "chapter/II", "kind": "chapter", "number": "II", "heading": "MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "article/5", "kind": "article", "number": "5", "heading": "Placing on the market and putting into service", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-5", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/6", "kind": "article", "number": "6", "heading": "Distance sales", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-6", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/7", "kind": "article", "number": "7", "heading": "Claims", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-7", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/8", "kind": "article", "number": "8", "heading": "Use of harmonised standards", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-8", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/9", "kind": "article", "number": "9", "heading": "Common specifications", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-9", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/10", "kind": "article", "number": "10", "heading": "General obligations of manufacturers", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-10", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/11", "kind": "article", "number": "11", "heading": "Authorised representative", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-11", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/12", "kind": "article", "number": "12", "heading": "Change of authorised representative", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-12", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/13", "kind": "article", "number": "13", "heading": "General obligations of importers", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-13", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/14", "kind": "article", "number": "14", "heading": "General obligations of distributors", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-14", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/15", "kind": "article", "number": "15", "heading": "Person responsible for regulatory compliance", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-15", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/16", "kind": "article", "number": "16", "heading": "Cases in which obligations of manufacturers apply to importers, distributors or other persons", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-16", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/17", "kind": "article", "number": "17", "heading": "Single-use devices and their reprocessing", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-17", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/18", "kind": "article", "number": "18", "heading": "Implant card and information to be supplied to the patient with an implanted device", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-18", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/19", "kind": "article", "number": "19", "heading": "EU declaration of conformity", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-19", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/20", "kind": "article", "number": "20", "heading": "CE marking of conformity", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-20", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/21", "kind": "article", "number": "21", "heading": "Devices for special purposes", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-21", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/22", "kind": "article", "number": "22", "heading": "Systems and procedure packs", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-22", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/23", "kind": "article", "number": "23", "heading": "Parts and components", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-23", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/24", "kind": "article", "number": "24", "heading": "Free movement", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-24", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "chapter/III", "kind": "chapter", "number": "III", "heading": "IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "article/25", "kind": "article", "number": "25", "heading": "Identification within the supply chain", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-25", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/26", "kind": "article", "number": "26", "heading": "Medical devices nomenclature", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-26", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/27", "kind": "article", "number": "27", "heading": "Unique Device Identification system", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-27", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/28", "kind": "article", "number": "28", "heading": "UDI database", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-28", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/29", "kind": "article", "number": "29", "heading": "Registration of devices", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-29", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/30", "kind": "article", "number": "30", "heading": "Electronic system for registration of economic operators", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-30", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/31", "kind": "article", "number": "31", "heading": "Registration of manufacturers, authorised representatives and importers", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-31", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/32", "kind": "article", "number": "32", "heading": "Summary of safety and clinical performance", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-32", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/33", "kind": "article", "number": "33", "heading": "European database on medical devices", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-33", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/34", "kind": "article", "number": "34", "heading": "Functionality of Eudamed", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-34", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "chapter/IV", "kind": "chapter", "number": "IV", "heading": "NOTIFIED BODIES", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "article/35", "kind": "article", "number": "35", "heading": "Authorities responsible for notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-35", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/36", "kind": "article", "number": "36", "heading": "Requirements relating to notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-36", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/37", "kind": "article", "number": "37", "heading": "Subsidiaries and subcontracting", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-37", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/38", "kind": "article", "number": "38", "heading": "Application by conformity assessment bodies for designation", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-38", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/39", "kind": "article", "number": "39", "heading": "Assessment of the application", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-39", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/40", "kind": "article", "number": "40", "heading": "Nomination of experts for joint assessment of applications for notification", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-40", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/41", "kind": "article", "number": "41", "heading": "Language requirements", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-41", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/42", "kind": "article", "number": "42", "heading": "Designation and notification procedure", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-42", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/43", "kind": "article", "number": "43", "heading": "Identification number and list of notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-43", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/44", "kind": "article", "number": "44", "heading": "Monitoring and re-assessment of notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-44", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/45", "kind": "article", "number": "45", "heading": "Review of notified body assessment of technical documentation and clinical evaluation documentation", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-45", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/46", "kind": "article", "number": "46", "heading": "Changes to designations and notifications", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-46", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/47", "kind": "article", "number": "47", "heading": "Challenge to the competence of notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-47", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/48", "kind": "article", "number": "48", "heading": "Peer review and exchange of experience between authorities responsible for notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-48", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/49", "kind": "article", "number": "49", "heading": "Coordination of notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-49", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/50", "kind": "article", "number": "50", "heading": "List of standard fees", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-50", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "chapter/V", "kind": "chapter", "number": "V", "heading": "CLASSIFICATION AND CONFORMITY ASSESSMENT", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "chapter/V/section/1", "kind": "section", "number": "1", "heading": "Classification", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V" }, { "path": "article/51", "kind": "article", "number": "51", "heading": "Classification of devices", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-51", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/1" }, { "path": "chapter/V/section/2", "kind": "section", "number": "2", "heading": "Conformity assessment", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V" }, { "path": "article/52", "kind": "article", "number": "52", "heading": "Conformity assessment procedures", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-52", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/53", "kind": "article", "number": "53", "heading": "Involvement of notified bodies in conformity assessment procedures", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-53", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/54", "kind": "article", "number": "54", "heading": "Clinical evaluation consultation procedure for certain class III and class IIb devices", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-54", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/55", "kind": "article", "number": "55", "heading": "Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-55", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/56", "kind": "article", "number": "56", "heading": "Certificates of conformity", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-56", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/57", "kind": "article", "number": "57", "heading": "Electronic system on notified bodies and on certificates of conformity", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-57", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/58", "kind": "article", "number": "58", "heading": "Voluntary change of notified body", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-58", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/59", "kind": "article", "number": "59", "heading": "Derogation from the conformity assessment procedures", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-59", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/60", "kind": "article", "number": "60", "heading": "Certificate of free sale", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-60", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "chapter/VI", "kind": "chapter", "number": "VI", "heading": "CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "article/61", "kind": "article", "number": "61", "heading": "Clinical evaluation", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-61", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/62", "kind": "article", "number": "62", "heading": "General requirements regarding clinical investigations conducted to demonstrate conformity of devices", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-62", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/63", "kind": "article", "number": "63", "heading": "Informed consent", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-63", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/64", "kind": "article", "number": "64", "heading": "Clinical investigations on incapacitated subjects", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-64", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/65", "kind": "article", "number": "65", "heading": "Clinical investigations on minors", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-65", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/66", "kind": "article", "number": "66", "heading": "Clinical investigations on pregnant or breastfeeding women", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-66", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/67", "kind": "article", "number": "67", "heading": "Additional national measures", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-67", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/68", "kind": "article", "number": "68", "heading": "Clinical investigations in emergency situations", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-68", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/69", "kind": "article", "number": "69", "heading": "Damage compensation", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-69", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/70", "kind": "article", "number": "70", "heading": "Application for clinical investigations", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-70", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/71", "kind": "article", "number": "71", "heading": "Assessment by Member States", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-71", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/72", "kind": "article", "number": "72", "heading": "Conduct of a clinical investigation", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-72", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/73", "kind": "article", "number": "73", "heading": "Electronic system on clinical investigations", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-73", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/74", "kind": "article", "number": "74", "heading": "Clinical investigations regarding devices bearing the CE marking", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-74", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/75", "kind": "article", "number": "75", "heading": "Substantial modifications to clinical investigations", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-75", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/76", "kind": "article", "number": "76", "heading": "Corrective measures to be taken by Member States and information exchange between Member States", "url": "https://openlegislation.uk/eu-regulation-2017-745/article-76", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/77", "kind": "article", "number": "77", "heading": "Information from the sponsor 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"annex/I/chapter/II/division/21" }, { "path": "annex/I/chapter/II/division/22", "kind": "division", "number": "22", "heading": "Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/I/chapter/II" }, { "path": "annex/I/chapter/II/division/22/division/22.1", "kind": "division", "number": "22.1", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-I/chapter-II/division-22/division-22.1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/I/chapter/II/division/22" }, { "path": "annex/I/chapter/II/division/22/division/22.2", "kind": "division", "number": "22.2", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-I/chapter-II/division-22/division-22.2", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/I/chapter/II/division/22" }, { "path": 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"status": "repealed", "parent": null }, { "path": "annex/III/division/1", "kind": "division", "number": "1", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-III/division-1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/III" }, { "path": "annex/III/division/2", "kind": "division", "number": "2", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-III/division-2", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/III" }, { "path": "annex/IV", "kind": "annex", "number": "IV", "heading": "EU DECLARATION OF CONFORMITY", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-IV", "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "annex/V", "kind": "annex", "number": "V", "heading": "CE MARKING OF CONFORMITY", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "annex/V/division/1", "kind": "division", "number": "1", "heading": "The CE marking shall consist of the initials ‘CE’ taking the following form:", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-V/division-1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/V" }, { "path": "annex/V/division/2", "kind": "division", "number": "2", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-V/division-2", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/V" }, { "path": "annex/V/division/3", "kind": "division", "number": "3", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-V/division-3", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/V" }, { "path": "annex/VI", "kind": "annex", "number": "VI", "heading": "INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29, AND THE UDI SYSTEM", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "annex/VI/part/A", "kind": "division", "number": "PART A", "heading": "INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-VI/part-A", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/VI" }, { "path": "annex/VI/part/B", "kind": "division", "number": "PART B", "heading": "CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-VI/part-B", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/VI" }, { "path": "annex/VI/part/C", "kind": "division", "number": "PART C", "heading": "THE UDI SYSTEM", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/VI" }, { "path": 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"https://openlegislation.uk/eu-regulation-2017-745/annex-VI/part-C/division-1/division-3", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/VI/part/C/division/1" }, { "path": "annex/VI/part/C/division/1/division/4", "kind": "division", "number": null, "heading": "Configurable device", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-VI/part-C/division-1/division-4", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/VI/part/C/division/1" }, { "path": "annex/VI/part/C/division/1/division/5", "kind": "division", "number": null, "heading": "Configuration", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-VI/part-C/division-1/division-5", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/VI/part/C/division/1" }, { "path": "annex/VI/part/C/division/1/division/6", "kind": "division", "number": null, "heading": "UDI-DI", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-VI/part-C/division-1/division-6", 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"annex/VI/part/C/division/1" }, { "path": "annex/VI/part/C/division/1/division/10", "kind": "division", "number": null, "heading": "Radio Frequency Identification RFID", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-VI/part-C/division-1/division-10", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/VI/part/C/division/1" }, { "path": "annex/VI/part/C/division/1/division/11", "kind": "division", "number": null, "heading": "Shipping containers", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-VI/part-C/division-1/division-11", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/VI/part/C/division/1" }, { "path": "annex/VI/part/C/division/1/division/12", "kind": "division", "number": null, "heading": "Unique Device Identifier (‘UDI’)", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-VI/part-C/division-1/division-12", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/VI/part/C/division/1" }, { "path": 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"repealed", "parent": "annex/IX/chapter/I/division/2" }, { "path": "annex/IX/chapter/I/division/2/division/2.4", "kind": "division", "number": "2.4", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-IX/chapter-I/division-2/division-2.4", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/IX/chapter/I/division/2" }, { "path": "annex/IX/chapter/I/division/3", "kind": "division", "number": "3", "heading": "Surveillance assessment", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/IX/chapter/I" }, { "path": "annex/IX/chapter/I/division/3/division/3.1", "kind": "division", "number": "3.1", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-IX/chapter-I/division-3/division-3.1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/IX/chapter/I/division/3" }, { "path": "annex/IX/chapter/I/division/3/division/3.2", "kind": "division", "number": "3.2", "heading": null, "url": 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"annex/XI/part/B/division/11", "kind": "division", "number": "11", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XI/part-B/division-11", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B" }, { "path": "annex/XI/part/B/division/12", "kind": "division", "number": "12", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XI/part-B/division-12", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B" }, { "path": "annex/XI/part/B/division/13", "kind": "division", "number": "13", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XI/part-B/division-13", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B" }, { "path": "annex/XI/part/B/division/14", "kind": "division", "number": "14", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XI/part-B/division-14", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B" }, { "path": "annex/XI/part/B/division/15", "kind": "division", "number": "15", "heading": "Verification by examination and testing of every product", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B" }, { "path": "annex/XI/part/B/division/15/division/15.1", "kind": "division", "number": "15.1", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XI/part-B/division-15/division-15.1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B/division/15" }, { "path": "annex/XI/part/B/division/15/division/15.2", "kind": "division", "number": "15.2", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XI/part-B/division-15/division-15.2", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B/division/15" }, { "path": "annex/XI/part/B/division/16", "kind": "division", "number": "16", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XI/part-B/division-16", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B" }, { "path": "annex/XI/part/B/division/17", "kind": "division", "number": "17", "heading": "Administrative provisions", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XI/part-B/division-17", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B" }, { "path": "annex/XI/part/B/division/18", "kind": "division", "number": "18", "heading": "Application to class IIa devices", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B" }, { "path": "annex/XI/part/B/division/18/division/18.1", "kind": "division", "number": "18.1", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XI/part-B/division-18/division-18.1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B/division/18" }, { "path": "annex/XI/part/B/division/18/division/18.2", "kind": "division", "number": "18.2", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XI/part-B/division-18/division-18.2", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B/division/18" }, { "path": "annex/XI/part/B/division/18/division/18.3", "kind": "division", "number": "18.3", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XI/part-B/division-18/division-18.3", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B/division/18" }, { "path": "annex/XI/part/B/division/18/division/18.4", "kind": "division", "number": "18.4", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XI/part-B/division-18/division-18.4", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XI/part/B/division/18" }, { "path": "annex/XII", "kind": "annex", "number": "XII", "heading": "CERTIFICATES ISSUED BY A NOTIFIED BODY", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "annex/XII/chapter/I", "kind": "division", "number": "CHAPTER I", "heading": "GENERAL REQUIREMENTS", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XII" }, { "path": "annex/XII/chapter/I/division/1", "kind": "division", "number": "1", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XII/chapter-I/division-1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XII/chapter/I" }, { "path": "annex/XII/chapter/I/division/2", "kind": "division", "number": "2", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XII/chapter-I/division-2", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XII/chapter/I" }, { "path": "annex/XII/chapter/I/division/3", "kind": "division", "number": "3", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XII/chapter-I/division-3", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XII/chapter/I" }, { "path": "annex/XII/chapter/I/division/4", "kind": "division", "number": "4", "heading": "The scope of the certificates shall unambiguously identify the device or devices covered:", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XII/chapter-I/division-4", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XII/chapter/I" }, { "path": "annex/XII/chapter/I/division/5", "kind": "division", "number": "5", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XII/chapter-I/division-5", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XII/chapter/I" }, { "path": "annex/XII/chapter/I/division/6", "kind": "division", "number": "6", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XII/chapter-I/division-6", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XII/chapter/I" }, { "path": "annex/XII/chapter/I/division/7", "kind": "division", "number": "7", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XII/chapter-I/division-7", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XII/chapter/I" }, { "path": "annex/XII/chapter/I/division/8", "kind": "division", "number": "8", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XII/chapter-I/division-8", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XII/chapter/I" }, { "path": "annex/XII/chapter/II", "kind": "division", "number": "CHAPTER II", "heading": "MINIMUM CONTENT OF THE CERTIFICATES", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XII/chapter-II", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XII" }, { "path": "annex/XIII", "kind": "annex", "number": "XIII", "heading": "PROCEDURE FOR CUSTOM-MADE DEVICES", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "annex/XIII/division/1", "kind": "division", "number": "1", "heading": "For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following information:", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIII/division-1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIII" }, { "path": "annex/XIII/division/2", "kind": "division", "number": "2", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIII/division-2", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIII" }, { "path": "annex/XIII/division/3", "kind": "division", "number": "3", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIII/division-3", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIII" }, { "path": "annex/XIII/division/4", "kind": "division", "number": "4", "heading": "The statement referred to in the introductory part of Section 1 shall be kept for a period of at least 10 years after the device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years.", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIII/division-4", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIII" }, { "path": "annex/XIII/division/5", "kind": "division", "number": "5", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIII/division-5", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIII" }, { "path": "annex/XIV", "kind": "annex", "number": "XIV", "heading": "CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "annex/XIV/part/A", "kind": "division", "number": "PART A", "heading": "CLINICAL EVALUATION", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIV" }, { "path": "annex/XIV/part/A/division/1", "kind": "division", "number": "1", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIV/part-A/division-1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIV/part/A" }, { "path": "annex/XIV/part/A/division/2", "kind": "division", "number": "2", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIV/part-A/division-2", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIV/part/A" }, { "path": "annex/XIV/part/A/division/3", "kind": "division", "number": "3", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIV/part-A/division-3", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIV/part/A" }, { "path": "annex/XIV/part/A/division/4", "kind": "division", "number": "4", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIV/part-A/division-4", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIV/part/A" }, { "path": "annex/XIV/part/B", "kind": "division", "number": "PART B", "heading": "POST-MARKET CLINICAL FOLLOW-UP", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIV" }, { "path": "annex/XIV/part/B/division/5", "kind": "division", "number": "5", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIV/part-B/division-5", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIV/part/B" }, { "path": "annex/XIV/part/B/division/6", "kind": "division", "number": "6", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIV/part-B/division-6", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIV/part/B" }, { "path": "annex/XIV/part/B/division/6/division/6.1", "kind": "division", "number": "6.1", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIV/part-B/division-6/division-6.1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIV/part/B/division/6" }, { "path": "annex/XIV/part/B/division/6/division/6.2", "kind": "division", "number": "6.2", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIV/part-B/division-6/division-6.2", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIV/part/B/division/6" }, { "path": "annex/XIV/part/B/division/7", "kind": "division", "number": "7", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIV/part-B/division-7", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIV/part/B" }, { "path": "annex/XIV/part/B/division/8", "kind": "division", "number": "8", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XIV/part-B/division-8", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XIV/part/B" }, { "path": "annex/XV", "kind": "annex", "number": "XV", "heading": "CLINICAL INVESTIGATIONS", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "annex/XV/chapter/I", "kind": "division", "number": "CHAPTER I", "heading": "GENERAL REQUIREMENTS", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XV" }, { "path": "annex/XV/chapter/I/division/1", "kind": "division", "number": "1", "heading": "Ethical principles", "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XV/chapter-I/division-1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XV/chapter/I" }, { "path": "annex/XV/chapter/I/division/2", "kind": "division", "number": "2", "heading": "Methods", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XV/chapter/I" }, { "path": "annex/XV/chapter/I/division/2/division/2.1", "kind": "division", "number": "2.1", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XV/chapter-I/division-2/division-2.1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XV/chapter/I/division/2" }, { "path": "annex/XV/chapter/I/division/2/division/2.2", "kind": "division", "number": "2.2", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XV/chapter-I/division-2/division-2.2", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XV/chapter/I/division/2" }, { "path": "annex/XV/chapter/I/division/2/division/2.3", "kind": "division", "number": "2.3", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XV/chapter-I/division-2/division-2.3", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XV/chapter/I/division/2" }, { "path": "annex/XV/chapter/I/division/2/division/2.4", "kind": "division", "number": "2.4", "heading": null, "url": "https://openlegislation.uk/eu-regulation-2017-745/annex-XV/chapter-I/division-2/division-2.4", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/XV/chapter/I/division/2" }, { "path": "annex/XV/chapter/I/division/2/division/2.5", "kind": "division", "number": "2.5", 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