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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)

EU Regulation 2017/746 · Adopted 5 April 2017 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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)

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations to the whole text

Textual amendments

F1

Regulation revoked (31.12.2020) by The Medical Devices Regulations 2002 (S.I. 2002/618), reg. 4P (as inserted by S.I. 2019/791, regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9(m)); 2020 c. 1, Sch. 5 para. 1(1))

Contents

  1. Chapter I: INTRODUCTORY PROVISIONS Repealed
  2. Scope and definitions Repealed
  3. 1Subject matter and scope Repealed
  4. 2Definitions Repealed
  5. Regulatory status of products and counselling Repealed
  6. 3Regulatory status of products Repealed
  7. 4Genetic information, counselling and informed consent Repealed
  8. Chapter II: MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, CE MARKING, FREE MOVEMENT Repealed
  9. 5Placing on the market and putting into service Repealed
  10. 6Distance sales Repealed
  11. 7Claims Repealed
  12. 8Use of harmonised standards Repealed
  13. 9Common specifications Repealed
  14. 10General obligations of manufacturers Repealed
  15. 11Authorised representative Repealed
  16. 12Change of authorised representative Repealed
  17. 13General obligations of importers Repealed
  18. 14General obligations of distributors Repealed
  19. 15Person responsible for regulatory compliance Repealed
  20. 16Cases in which obligations of manufacturers apply to importers, distributors or other persons Repealed
  21. 17EU declaration of conformity Repealed
  22. 18CE marking of conformity Repealed
  23. 19Devices for special purposes Repealed
  24. 20Parts and components Repealed
  25. 21Free movement Repealed
  26. Chapter III: IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES Repealed
  27. 22Identification within the supply chain Repealed
  28. 23Medical devices nomenclature Repealed
  29. 24Unique Device Identification system Repealed
  30. 25UDI database Repealed
  31. 26Registration of devices Repealed
  32. 27Electronic system for registration of economic operators Repealed
  33. 28Registration of manufacturers, authorised representatives and importers Repealed
  34. 29Summary of safety and performance Repealed
  35. 30European database on medical devices Repealed
  36. Chapter IV: NOTIFIED BODIES Repealed
  37. 31Authorities responsible for notified bodies Repealed
  38. 32Requirements relating to notified bodies Repealed
  39. 33Subsidiaries and subcontracting Repealed
  40. 34Application by conformity assessment bodies for designation Repealed
  41. 35Assessment of the application Repealed
  42. 36Nomination of experts for joint assessment of applications for notification Repealed
  43. 37Language requirements Repealed
  44. 38Designation and notification procedure Repealed
  45. 39Identification number and list of notified bodies Repealed
  46. 40Monitoring and re-assessment of notified bodies Repealed
  47. 41Review of notified body assessment of technical documentation and performance evaluation documentation Repealed
  48. 42Changes to designations and notifications Repealed
  49. 43Challenge to the competence of notified bodies Repealed
  50. 44Peer review and exchange of experience between authorities responsible for notified bodies Repealed
  51. 45Coordination of notified bodies Repealed
  52. 46List of standard fees Repealed
  53. Chapter V: CLASSIFICATION AND CONFORMITY ASSESSMENT Repealed
  54. Classification Repealed
  55. 47Classification of devices Repealed
  56. Conformity assessment Repealed
  57. 48Conformity assessment procedures Repealed
  58. 49Involvement of notified bodies in conformity assessment procedures Repealed
  59. 50Mechanism for scrutiny of conformity assessments of class D devices Repealed
  60. 51Certificates of conformity Repealed
  61. 52Electronic system on notified bodies and on certificates of conformity Repealed
  62. 53Voluntary change of notified body Repealed
  63. 54Derogation from the conformity assessment procedures Repealed
  64. 55Certificate of free sale Repealed
  65. Chapter VI: CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES Repealed
  66. 56Performance evaluation and clinical evidence Repealed
  67. 57General requirements regarding performance studies Repealed
  68. 58Additional requirements for certain performance studies Repealed
  69. 59Informed consent Repealed
  70. 60Performance studies on incapacitated subjects Repealed
  71. 61Performance studies on minors Repealed
  72. 62Performance studies on pregnant or breastfeeding women Repealed
  73. 63Additional national measures Repealed
  74. 64Performance studies in emergency situations Repealed
  75. 65Damage compensation Repealed
  76. 66Application for performance studies Repealed
  77. 67Assessment by Member States Repealed
  78. 68Conduct of a performance study Repealed
  79. 69Electronic system on performance studies Repealed
  80. 70Performance studies regarding devices bearing the CE marking Repealed
  81. 71Substantial modifications to performance studies Repealed
  82. 72Corrective measures to be taken by Member States and information exchange between Member States on performance studies Repealed
  83. 73Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination Repealed
  84. 74Coordinated assessment procedure for performance studies Repealed
  85. 75Review of the coordinated assessment procedure Repealed
  86. 76Recording and reporting of adverse events that occur during performance studies Repealed
  87. 77Implementing acts Repealed
  88. Chapter VII: POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE Repealed
  89. Post-market surveillance Repealed
  90. 78Post-market surveillance system of the manufacturer Repealed
  91. 79Post-market surveillance plan Repealed
  92. 80Post-market surveillance report Repealed
  93. 81Periodic safety update report Repealed
  94. Vigilance Repealed
  95. 82Reporting of serious incidents and field safety corrective actions Repealed
  96. 83Trend reporting Repealed
  97. 84Analysis of serious incidents and field safety corrective actions Repealed
  98. 85Analysis of vigilance data Repealed
  99. 86Implementing acts Repealed
  100. 87Electronic system on vigilance and post-market surveillance Repealed
  101. Market surveillance Repealed
  102. 88Market surveillance activities Repealed
  103. 89Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance Repealed
  104. 90Procedure for dealing with devices presenting an unacceptable risk to health and safety Repealed
  105. 91Procedure for evaluating national measures at Union level Repealed
  106. 92Other non-compliance Repealed
  107. 93Preventive health protection measures Repealed
  108. 94Good administrative practice Repealed
  109. 95Electronic system on market surveillance Repealed
  110. Chapter VIII: COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EU REFERENCE LABORATORIES AND DEVICE REGISTERS Repealed
  111. 96Competent authorities Repealed
  112. 97Cooperation Repealed
  113. 98Medical Device Coordination Group Repealed
  114. 99Tasks of the MDCG Repealed
  115. 100The European Union reference laboratories Repealed
  116. 101Device registers and databanks Repealed
  117. Chapter IX: CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES Repealed
  118. 102Confidentiality Repealed
  119. 103Data protection Repealed
  120. 104Levying of fees Repealed
  121. 105Funding of activities related to designation and monitoring of notified bodies Repealed
  122. 106Penalties Repealed
  123. Chapter X: FINAL PROVISIONS Repealed
  124. 107Committee procedure Repealed
  125. 108Exercise of the delegation Repealed
  126. 109Separate delegated acts for different delegated powers Repealed
  127. 110Transitional provisions Repealed
  128. 111Evaluation Repealed
  129. 112Repeal Repealed
  130. 113Entry into force and date of application Repealed
  131. Signature
  132. Annex I: GENERAL SAFETY AND PERFORMANCE REQUIREMENTS Repealed
  133. GENERAL REQUIREMENTS Repealed
  134. 1Division 1 Repealed
  135. 2Division 2 Repealed
  136. 3Division 3 Repealed
  137. 4Division 4 Repealed
  138. 5Division 5 Repealed
  139. 6Division 6 Repealed
  140. 7Division 7 Repealed
  141. 8Division 8 Repealed
  142. REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE Repealed
  143. Performance characteristics Repealed
  144. 9.1Division 9.1 Repealed
  145. 9.2Division 9.2 Repealed
  146. 9.3Division 9.3 Repealed
  147. 9.4Division 9.4 Repealed
  148. Chemical, physical and biological properties Repealed
  149. 10.1Division 10.1 Repealed
  150. 10.2Division 10.2 Repealed
  151. 10.3Division 10.3 Repealed
  152. 10.4Division 10.4 Repealed
  153. Infection and microbial contamination Repealed
  154. 11.1Division 11.1 Repealed
  155. 11.2Division 11.2 Repealed
  156. 11.3Division 11.3 Repealed
  157. 11.4Division 11.4 Repealed
  158. 11.5Division 11.5 Repealed
  159. 11.6Division 11.6 Repealed
  160. 12Devices incorporating materials of biological origin Repealed
  161. Construction of devices and interaction with their environment Repealed
  162. 13.1Division 13.1 Repealed
  163. 13.2Division 13.2 Repealed
  164. 13.3Division 13.3 Repealed
  165. 13.4Division 13.4 Repealed
  166. 13.5Division 13.5 Repealed
  167. 13.6Division 13.6 Repealed
  168. 13.7Division 13.7 Repealed
  169. Devices with a measuring function Repealed
  170. 14.1Division 14.1 Repealed
  171. 14.2Division 14.2 Repealed
  172. Protection against radiation Repealed
  173. 15.1Division 15.1 Repealed
  174. 15.2Division 15.2 Repealed
  175. 15.3Division 15.3 Repealed
  176. Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves Repealed
  177. 16.1Division 16.1 Repealed
  178. 16.2Division 16.2 Repealed
  179. 16.3Division 16.3 Repealed
  180. 16.4Division 16.4 Repealed
  181. Devices connected to or equipped with an energy source Repealed
  182. 17.1Division 17.1 Repealed
  183. 17.2Division 17.2 Repealed
  184. 17.3Division 17.3 Repealed
  185. 17.4Division 17.4 Repealed
  186. 17.5Division 17.5 Repealed
  187. Protection against mechanical and thermal risks Repealed
  188. 18.1Division 18.1 Repealed
  189. 18.2Division 18.2 Repealed
  190. 18.3Division 18.3 Repealed
  191. 18.4Division 18.4 Repealed
  192. 18.5Division 18.5 Repealed
  193. 18.6Division 18.6 Repealed
  194. 18.7Division 18.7 Repealed
  195. 18.8Division 18.8 Repealed
  196. Protection against the risks posed by devices intended for self-testing or near-patient testing Repealed
  197. 19.1Division 19.1 Repealed
  198. 19.2Division 19.2 Repealed
  199. 19.3Division 19.3 Repealed
  200. REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE Repealed
  201. Label and instructions for use Repealed
  202. 20.1General requirements regarding the information supplied by the manufacturer Repealed
  203. 20.2Information on the label Repealed
  204. 20.3Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’): Repealed
  205. Information in the instructions for use Repealed
  206. 20.4.1Division 20.4.1 Repealed
  207. 20.4.2Division 20.4.2 Repealed
  208. Annex IITECHNICAL DOCUMENTATION Repealed
  209. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES Repealed
  210. 1.1Device description and specification Repealed
  211. 1.2Reference to previous and similar generations of the device Repealed
  212. 2INFORMATION TO BE SUPPLIED BY THE MANUFACTURER Repealed
  213. DESIGN AND MANUFACTURING INFORMATION Repealed
  214. 3.1Design information Repealed
  215. 3.2Manufacturing information Repealed
  216. 4GENERAL SAFETY AND PERFORMANCE REQUIREMENTS Repealed
  217. 5BENFIT-RISK ANALYSIS AND RISK MANAGEMENT Repealed
  218. 6PRODUCT VERIFICATION AND VALIDATION Repealed
  219. Annex IIITECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE Repealed
  220. 1The post-market surveillance plan drawn up in accordance with Article 79. Repealed
  221. 2The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80. Repealed
  222. Annex IVEU DECLARATION OF CONFORMITY Repealed
  223. Annex V: CE MARKING OF CONFORMITY Repealed
  224. 1The CE marking shall consist of the initials ‘CE’ taking the following form: Repealed
  225. 2Division 2 Repealed
  226. 3Division 3 Repealed
  227. Annex VI: INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 AND THE UDI SYSTEM Repealed
  228. PART AINFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28 Repealed
  229. PART BCORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 Repealed
  230. THE UDI SYSTEM Repealed
  231. Definitions Repealed
  232. Automatic identification and data capture (‘AIDC’) Repealed
  233. Basic UDI-DI Repealed
  234. Unit of Use DI Repealed
  235. Configurable device Repealed
  236. Configuration Repealed
  237. UDI-DI Repealed
  238. Human Readable Interpretation (HRI) Repealed
  239. Packaging levels Repealed
  240. Production Identifier (UDI-PI) Repealed
  241. Radio Frequency Identification (‘RFID’) Repealed
  242. Shipping containers Repealed
  243. Unique Device Identifier (‘UDI’) Repealed
  244. UDI carrier Repealed
  245. General requirements Repealed
  246. 2.1Division 2.1 Repealed
  247. 2.2Division 2.2 Repealed
  248. 2.3Division 2.3 Repealed
  249. 2.4Division 2.4 Repealed
  250. The UDI Repealed
  251. 3.1Division 3.1 Repealed
  252. 3.2Division 3.2 Repealed
  253. 3.3Division 3.3 Repealed
  254. 3.4Division 3.4 Repealed
  255. 3.5Division 3.5 Repealed
  256. 3.6Division 3.6 Repealed
  257. 3.7Division 3.7 Repealed
  258. 3.8Division 3.8 Repealed
  259. 3.9Division 3.9 Repealed
  260. 3.10Division 3.10 Repealed
  261. UDI carrier Repealed
  262. 4.1Division 4.1 Repealed
  263. 4.2Division 4.2 Repealed
  264. 4.3Division 4.3 Repealed
  265. 4.4Division 4.4 Repealed
  266. 4.5Division 4.5 Repealed
  267. 4.6Division 4.6 Repealed
  268. 4.7Division 4.7 Repealed
  269. 4.8Division 4.8 Repealed
  270. 4.9Division 4.9 Repealed
  271. 4.10Division 4.10 Repealed
  272. 4.11Division 4.11 Repealed
  273. 4.12Division 4.12 Repealed
  274. 4.13Division 4.13 Repealed
  275. 4.14Division 4.14 Repealed
  276. 4.15Division 4.15 Repealed
  277. General principles of the UDI database Repealed
  278. 5.1Division 5.1 Repealed
  279. 5.2Division 5.2 Repealed
  280. 5.3Division 5.3 Repealed
  281. 5.4Division 5.4 Repealed
  282. 5.5Division 5.5 Repealed
  283. 5.6Division 5.6 Repealed
  284. 5.7Division 5.7 Repealed
  285. 5.8Division 5.8 Repealed
  286. 5.9Division 5.9 Repealed
  287. 5.10Division 5.10 Repealed
  288. 5.11Division 5.11 Repealed
  289. Rules for specific device types Repealed
  290. Reusable devices that are part of kits and that require cleaning, disinfection, sterilisation or refurbishing between uses Repealed
  291. 6.1.1Division 6.1.1 Repealed
  292. 6.1.2Division 6.1.2 Repealed
  293. Device software Repealed
  294. 6.2.1UDI assignment Criteria Repealed
  295. 6.2.2Division 6.2.2 Repealed
  296. 6.2.3Division 6.2.3 Repealed
  297. 6.2.4UDI placement criteria for software Repealed
  298. Annex VII: REQUIREMENTS TO BE MET BY NOTIFIED BODIES Repealed
  299. ORGANISATIONAL AND GENERAL REQUIREMENTS Repealed
  300. Legal status and organisational structure Repealed
  301. 1.1.1Division 1.1.1 Repealed
  302. 1.1.2Division 1.1.2 Repealed
  303. 1.1.3Division 1.1.3 Repealed
  304. 1.1.4Division 1.1.4 Repealed
  305. 1.1.5Division 1.1.5 Repealed
  306. 1.1.6Division 1.1.6 Repealed
  307. Independence and impartiality Repealed
  308. 1.2.1Division 1.2.1 Repealed
  309. 1.2.2Division 1.2.2 Repealed
  310. 1.2.3Division 1.2.3 Repealed
  311. 1.2.4Division 1.2.4 Repealed
  312. 1.2.5Division 1.2.5 Repealed
  313. 1.2.6Division 1.2.6 Repealed
  314. 1.2.7Division 1.2.7 Repealed
  315. 1.2.8Division 1.2.8 Repealed
  316. 1.2.9Division 1.2.9 Repealed
  317. Confidentiality Repealed
  318. 1.3.1Division 1.3.1 Repealed
  319. 1.3.2Division 1.3.2 Repealed
  320. Liability Repealed
  321. 1.4.1Division 1.4.1 Repealed
  322. 1.4.2Division 1.4.2 Repealed
  323. 1.5Financial requirements Repealed
  324. Participation in coordination activities Repealed
  325. 1.6.1Division 1.6.1 Repealed
  326. 1.6.2Division 1.6.2 Repealed
  327. QUALITY MANAGEMENT REQUIREMENTS Repealed
  328. 2.1Division 2.1 Repealed
  329. 2.2Division 2.2 Repealed
  330. 2.3Division 2.3 Repealed
  331. 2.4Division 2.4 Repealed
  332. RESOURCE REQUIREMENTS Repealed
  333. General Repealed
  334. 3.1.1Division 3.1.1 Repealed
  335. 3.1.2Division 3.1.2 Repealed
  336. 3.1.3Division 3.1.3 Repealed
  337. Qualification criteria in relation to personnel Repealed
  338. 3.2.1Division 3.2.1 Repealed
  339. 3.2.2Division 3.2.2 Repealed
  340. 3.2.3Division 3.2.3 Repealed
  341. 3.2.4Division 3.2.4 Repealed
  342. 3.2.5Division 3.2.5 Repealed
  343. 3.2.6Division 3.2.6 Repealed
  344. 3.2.7Division 3.2.7 Repealed
  345. Documentation of qualification, training and authorisation of personnel Repealed
  346. 3.3.1Division 3.3.1 Repealed
  347. 3.3.2Division 3.3.2 Repealed
  348. Subcontractors and external experts Repealed
  349. 3.4.1Division 3.4.1 Repealed
  350. 3.4.2Division 3.4.2 Repealed
  351. 3.4.3Division 3.4.3 Repealed
  352. Monitoring of competences, training and exchange of experience Repealed
  353. 3.5.1Division 3.5.1 Repealed
  354. 3.5.2Division 3.5.2 Repealed
  355. PROCESS REQUIREMENTS Repealed
  356. 4.1General Repealed
  357. 4.2Notified body quotations and pre-application activities Repealed
  358. 4.3Application review and contract Repealed
  359. 4.4Allocation of resources Repealed
  360. Conformity assessment activities Repealed
  361. 4.5.1General Repealed
  362. 4.5.2Quality management system auditing Repealed
  363. Product verification Repealed
  364. Assessment of the technical documentation Repealed
  365. Type-examinations Repealed
  366. Verification by examination and testing of every product batch Repealed
  367. 4.5.4Performance evaluation assessment Repealed
  368. 4.5.5Specific Procedures Repealed
  369. 4.6Reporting Repealed
  370. 4.7Final review Repealed
  371. 4.8Decisions and certifications Repealed
  372. 4.9Changes and modifications Repealed
  373. 4.10Surveillance activities and post-certification monitoring Repealed
  374. 4.11Re-certification Repealed
  375. Annex VIII: CLASSIFICATION RULES Repealed
  376. IMPLEMENTING RULES Repealed
  377. 1.1Division 1.1 Repealed
  378. 1.2Division 1.2 Repealed
  379. 1.3Division 1.3 Repealed
  380. 1.4Division 1.4 Repealed
  381. 1.5Division 1.5 Repealed
  382. 1.6Division 1.6 Repealed
  383. 1.7Division 1.7 Repealed
  384. 1.8Division 1.8 Repealed
  385. 1.9Division 1.9 Repealed
  386. 1.10Division 1.10 Repealed
  387. CLASSIFICATION RULES Repealed
  388. 2.1Rule 1 Repealed
  389. 2.2Rule 2 Repealed
  390. 2.3Rule 3 Repealed
  391. 2.4Rule 4 Repealed
  392. 2.5Rule 5 Repealed
  393. 2.6Rule 6 Repealed
  394. 2.7Rule 7 Repealed
  395. Annex IX: CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION Repealed
  396. QUALITY MANAGEMENT SYSTEM Repealed
  397. 1Division 1 Repealed
  398. Quality management system assessment Repealed
  399. 2.1Division 2.1 Repealed
  400. 2.2Division 2.2 Repealed
  401. 2.3Audit Repealed
  402. 2.4Division 2.4 Repealed
  403. Surveillance assessment Repealed
  404. 3.1Division 3.1 Repealed
  405. 3.2Division 3.2 Repealed
  406. 3.3Division 3.3 Repealed
  407. 3.4Division 3.4 Repealed
  408. 3.5Division 3.5 Repealed
  409. 3.6Division 3.6 Repealed
  410. 3.7Division 3.7 Repealed
  411. ASSESSMENT OF THE TECHNICAL DOCUMENTATION Repealed
  412. Assessment of the technical documentation of class B, C and D devices and batch verification applicable to class D devices Repealed
  413. 4.1Division 4.1 Repealed
  414. 4.2Division 4.2 Repealed
  415. 4.3Division 4.3 Repealed
  416. 4.4Division 4.4 Repealed
  417. 4.5Division 4.5 Repealed
  418. 4.6Division 4.6 Repealed
  419. 4.7Division 4.7 Repealed
  420. 4.8Division 4.8 Repealed
  421. 4.9Division 4.9 Repealed
  422. 4.10Division 4.10 Repealed
  423. 4.11Division 4.11 Repealed
  424. 4.12Division 4.12 Repealed
  425. 4.13Division 4.13 Repealed
  426. Assessment of the technical documentation of specific types of devices Repealed
  427. 5.1Assessment of the technical documentation of class B, C and D devices for self-testing and near-patient testing Repealed
  428. 5.2Assessment of the technical documentation of companion diagnostics Repealed
  429. ADMINISTRATIVE PROVISIONS Repealed
  430. 6Division 6 Repealed
  431. 7Division 7 Repealed
  432. Annex X: CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION Repealed
  433. 1Division 1 Repealed
  434. 2Application Repealed
  435. 3Assessment Repealed
  436. 4Certificate Repealed
  437. Changes to the type Repealed
  438. 5.1Division 5.1 Repealed
  439. 5.2Division 5.2 Repealed
  440. 5.3Division 5.3 Repealed
  441. 5.4Division 5.4 Repealed
  442. 5.5Division 5.5 Repealed
  443. 6Administrative provisions Repealed
  444. Annex XI: CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE Repealed
  445. 1Division 1 Repealed
  446. 2Division 2 Repealed
  447. Quality management system Repealed
  448. 3.1Division 3.1 Repealed
  449. 3.2Division 3.2 Repealed
  450. 3.3Division 3.3 Repealed
  451. 3.4Division 3.4 Repealed
  452. 4Surveillance Repealed
  453. Verification of manufactured class D devices Repealed
  454. 5.1Division 5.1 Repealed
  455. 5.2Division 5.2 Repealed
  456. 6Administrative provisions Repealed
  457. Annex XII: CERTIFICATES ISSUED BY A NOTIFIED BODY Repealed
  458. CHAPTER IGENERAL REQUIREMENTS Repealed
  459. CHAPTER IIMINIMUM CONTENT OF THE CERTIFICATES Repealed
  460. Annex XIII: PERFORMANCE EVALUATION, PERFORMANCE STUDIES AND POST-MARKET PERFORMANCE FOLLOW-UP Repealed
  461. PERFORMANCE EVALUATION AND PERFORMANCE STUDIES Repealed
  462. 1PERFORMANCE EVALUATION Repealed
  463. CLINICAL PERFORMANCE STUDIES Repealed
  464. 2.1Purpose of clinical performance studies Repealed
  465. 2.2Ethical considerations for clinical performance studies Repealed
  466. Methods for clinical performance studies Repealed
  467. 2.3.1Clinical performance study design type Repealed
  468. 2.3.2Clinical performance study plan Repealed
  469. 2.3.3Clinical performance study report Repealed
  470. 3OTHER PERFORMANCE STUDIES Repealed
  471. POST-MARKET PERFORMANCE FOLLOW-UP Repealed
  472. 4Division 4 Repealed
  473. 5Division 5 Repealed
  474. 5.1Division 5.1 Repealed
  475. 5.2Division 5.2 Repealed
  476. 6Division 6 Repealed
  477. 7Division 7 Repealed
  478. 8Division 8 Repealed
  479. Annex XIV: INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES Repealed
  480. CHAPTER IDOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES Repealed
  481. CHAPTER IIOTHER OBLIGATIONS OF THE SPONSOR Repealed
  482. Annex XVCORRELATION TABLE Repealed