{ "url": "https://openlegislation.uk/eu-regulation-2017-746", "json_url": "https://openlegislation.uk/eu-regulation-2017-746.json", "id": "eur/2017/746", "title": "Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance) (revoked)", "short_title": "Regulation (EU) 2017/746 on in vitro diagnostic medical devices", "long_title": "Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)", "citation": "EU Regulation 2017/746", "type": "eur", "year": "2017", "number": "746", "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-2017-746/introduction", "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "chapter/I", "kind": "chapter", "number": "I", "heading": "INTRODUCTORY PROVISIONS", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "chapter/I/section/1", "kind": "section", "number": "1", "heading": "Scope and definitions", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/I" }, { "path": "article/1", "kind": "article", "number": "1", "heading": "Subject matter and scope", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-1", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/I/section/1" }, { "path": "article/2", "kind": "article", "number": "2", "heading": "Definitions", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-2", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/I/section/1" }, { "path": "chapter/I/section/2", "kind": "section", "number": "2", "heading": "Regulatory status of products and counselling", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/I" }, { "path": "article/3", "kind": "article", "number": "3", "heading": "Regulatory status of products", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-3", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/I/section/2" }, { "path": "article/4", "kind": "article", "number": "4", "heading": "Genetic information, counselling and informed consent", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-4", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/I/section/2" }, { "path": "chapter/II", "kind": "chapter", "number": "II", "heading": "MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, 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-2017-746/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-2017-746/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-2017-746/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-2017-746/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-2017-746/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-2017-746/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-2017-746/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-2017-746/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-2017-746/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-2017-746/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-2017-746/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-2017-746/article-16", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/17", "kind": "article", "number": "17", "heading": "EU declaration of conformity", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-17", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/18", "kind": "article", "number": "18", "heading": "CE marking of conformity", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-18", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/19", "kind": "article", "number": "19", "heading": "Devices for special purposes", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-19", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/20", "kind": "article", "number": "20", "heading": "Parts and components", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-20", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/II" }, { "path": "article/21", "kind": "article", "number": "21", "heading": "Free movement", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-21", "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/22", "kind": "article", "number": "22", "heading": "Identification within the supply chain", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-22", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/23", "kind": "article", "number": "23", "heading": "Medical devices nomenclature", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-23", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/24", "kind": "article", "number": "24", "heading": "Unique Device Identification system", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-24", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/25", "kind": "article", "number": "25", "heading": "UDI database", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-25", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/26", "kind": "article", "number": "26", "heading": "Registration of devices", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-26", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/27", "kind": "article", "number": "27", "heading": "Electronic system for registration of economic operators", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-27", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/28", "kind": "article", "number": "28", "heading": "Registration of manufacturers, authorised representatives and importers", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-28", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/29", "kind": "article", "number": "29", "heading": "Summary of safety and performance", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-29", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/III" }, { "path": "article/30", "kind": "article", "number": "30", "heading": "European database on medical devices", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-30", "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/31", "kind": "article", "number": "31", "heading": "Authorities responsible for notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-31", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/32", "kind": "article", "number": "32", "heading": "Requirements relating to notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-32", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/33", "kind": "article", "number": "33", "heading": "Subsidiaries and subcontracting", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-33", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/34", "kind": "article", "number": "34", "heading": "Application by conformity assessment bodies for designation", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-34", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/35", "kind": "article", "number": "35", "heading": "Assessment of the application", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-35", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/36", "kind": "article", "number": "36", "heading": "Nomination of experts for joint assessment of applications for notification", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-36", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/37", "kind": "article", "number": "37", "heading": "Language requirements", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-37", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/38", "kind": "article", "number": "38", "heading": "Designation and notification procedure", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-38", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/39", "kind": "article", "number": "39", "heading": "Identification number and list of notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-39", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/40", "kind": "article", "number": "40", "heading": "Monitoring and re-assessment of notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-40", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/41", "kind": "article", "number": "41", "heading": "Review of notified body assessment of technical documentation and performance evaluation documentation", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-41", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/42", "kind": "article", "number": "42", "heading": "Changes to designations and notifications", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-42", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/43", "kind": "article", "number": "43", "heading": "Challenge to the competence of notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-43", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/44", "kind": "article", "number": "44", "heading": "Peer review and exchange of experience between authorities responsible for notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-44", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/45", "kind": "article", "number": "45", "heading": "Coordination of notified bodies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-45", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/IV" }, { "path": "article/46", "kind": "article", "number": "46", "heading": "List of standard fees", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-46", "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/47", "kind": "article", "number": "47", "heading": "Classification of devices", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-47", "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/48", "kind": "article", "number": "48", "heading": "Conformity assessment procedures", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-48", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/49", "kind": "article", "number": "49", "heading": "Involvement of notified bodies in conformity assessment procedures", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-49", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/50", "kind": "article", "number": "50", "heading": "Mechanism for scrutiny of conformity assessments of class D devices", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-50", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/51", "kind": "article", "number": "51", "heading": "Certificates of conformity", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-51", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/52", "kind": "article", "number": "52", "heading": "Electronic system on notified bodies and on certificates of conformity", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-52", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/53", "kind": "article", "number": "53", "heading": "Voluntary change of notified body", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-53", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/54", "kind": "article", "number": "54", "heading": "Derogation from the conformity assessment procedures", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-54", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "article/55", "kind": "article", "number": "55", "heading": "Certificate of free sale", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-55", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/V/section/2" }, { "path": "chapter/VI", "kind": "chapter", "number": "VI", "heading": "CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "article/56", "kind": "article", "number": "56", "heading": "Performance evaluation and clinical evidence", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-56", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/57", "kind": "article", "number": "57", "heading": "General requirements regarding performance studies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-57", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/58", "kind": "article", "number": "58", "heading": "Additional requirements for certain performance studies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-58", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/59", "kind": "article", "number": "59", "heading": "Informed consent", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-59", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/60", "kind": "article", "number": "60", "heading": "Performance studies on incapacitated subjects", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-60", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/61", "kind": "article", "number": "61", "heading": "Performance studies on minors", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-61", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/62", "kind": "article", "number": "62", "heading": "Performance studies on pregnant or breastfeeding women", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-62", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/63", "kind": "article", "number": "63", "heading": "Additional national measures", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-63", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/64", "kind": "article", "number": "64", "heading": "Performance studies in emergency situations", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-64", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/65", "kind": "article", "number": "65", "heading": "Damage compensation", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-65", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/66", "kind": "article", "number": "66", "heading": "Application for performance studies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-66", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/67", "kind": "article", "number": "67", "heading": "Assessment by Member States", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-67", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/68", "kind": "article", "number": "68", "heading": "Conduct of a performance study", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-68", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/69", "kind": "article", "number": "69", "heading": "Electronic system on performance studies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-69", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/70", "kind": "article", "number": "70", "heading": "Performance studies regarding devices bearing the CE marking", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-70", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/71", "kind": "article", "number": "71", "heading": "Substantial modifications to performance studies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-71", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/72", "kind": "article", "number": "72", "heading": "Corrective measures to be taken by Member States and information exchange between Member States on performance studies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-72", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/73", "kind": "article", "number": "73", "heading": "Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-73", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/74", "kind": "article", "number": "74", "heading": "Coordinated assessment procedure for performance studies", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-74", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/75", "kind": "article", "number": "75", "heading": "Review of the coordinated assessment procedure", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-75", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VI" }, { "path": "article/76", "kind": "article", "number": "76", "heading": "Recording 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"https://openlegislation.uk/eu-regulation-2017-746/article-78", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/1" }, { "path": "article/79", "kind": "article", "number": "79", "heading": "Post-market surveillance plan", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-79", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/1" }, { "path": "article/80", "kind": "article", "number": "80", "heading": "Post-market surveillance report", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-80", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/1" }, { "path": "article/81", "kind": "article", "number": "81", "heading": "Periodic safety update report", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-81", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/1" }, { "path": "chapter/VII/section/2", "kind": "section", "number": "2", "heading": "Vigilance", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII" }, { "path": "article/82", "kind": "article", "number": "82", "heading": "Reporting of serious incidents and field safety corrective actions", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-82", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/2" }, { "path": "article/83", "kind": "article", "number": "83", "heading": "Trend reporting", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-83", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/2" }, { "path": "article/84", "kind": "article", "number": "84", "heading": "Analysis of serious incidents and field safety corrective actions", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-84", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/2" }, { "path": "article/85", "kind": "article", "number": "85", "heading": "Analysis of vigilance data", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-85", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/2" }, { "path": "article/86", "kind": "article", "number": "86", "heading": "Implementing acts", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-86", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/2" }, { "path": "article/87", "kind": "article", "number": "87", "heading": "Electronic system on vigilance and post-market surveillance", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-87", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/2" }, { "path": "chapter/VII/section/3", "kind": "section", "number": "3", "heading": "Market surveillance", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII" }, { "path": "article/88", "kind": "article", "number": "88", "heading": "Market surveillance 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"https://openlegislation.uk/eu-regulation-2017-746/article-91", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/3" }, { "path": "article/92", "kind": "article", "number": "92", "heading": "Other non-compliance", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-92", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/3" }, { "path": "article/93", "kind": "article", "number": "93", "heading": "Preventive health protection measures", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-93", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/3" }, { "path": "article/94", "kind": "article", "number": "94", "heading": "Good administrative practice", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-94", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/VII/section/3" }, { "path": "article/95", "kind": "article", "number": "95", "heading": "Electronic 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"chapter/X" }, { "path": "article/113", "kind": "article", "number": "113", "heading": "Entry into force and date of application", "url": "https://openlegislation.uk/eu-regulation-2017-746/article-113", "extent": "E+W+S+N.I.", "status": "repealed", "parent": "chapter/X" }, { "path": "signature", "kind": "signature", "number": null, "heading": "Signature", "url": "https://openlegislation.uk/eu-regulation-2017-746/signature", "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "annex/I", "kind": "annex", "number": "I", "heading": "GENERAL SAFETY AND PERFORMANCE REQUIREMENTS", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": null }, { "path": "annex/I/chapter/I", "kind": "division", "number": "CHAPTER I", "heading": "GENERAL REQUIREMENTS", "url": null, "extent": "E+W+S+N.I.", "status": "repealed", "parent": "annex/I" }, { "path": "annex/I/chapter/I/division/1", "kind": "division", "number": "1", "heading": null, "url": 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