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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)

EU Regulation 2017/745 · 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) 2017/745 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)

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. 4O (with savings and transitional provisions for N.I. in reg. 3ZA) (as amended by S.I. 2019/791, regs. 1(1), 3(7) and by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2; and as amended (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 4, 32); 2020 c. 1, Sch. 5 para. 1(1))

Contents

  1. Chapter I: SCOPE AND DEFINITIONS Repealed
  2. 1Subject matter and scope Repealed
  3. 2Definitions Repealed
  4. 3Amendment of certain definitions Repealed
  5. 4Regulatory status of products Repealed
  6. Chapter II: MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT Repealed
  7. 5Placing on the market and putting into service Repealed
  8. 6Distance sales Repealed
  9. 7Claims Repealed
  10. 8Use of harmonised standards Repealed
  11. 9Common specifications Repealed
  12. 10General obligations of manufacturers Repealed
  13. 11Authorised representative Repealed
  14. 12Change of authorised representative Repealed
  15. 13General obligations of importers Repealed
  16. 14General obligations of distributors Repealed
  17. 15Person responsible for regulatory compliance Repealed
  18. 16Cases in which obligations of manufacturers apply to importers, distributors or other persons Repealed
  19. 17Single-use devices and their reprocessing Repealed
  20. 18Implant card and information to be supplied to the patient with an implanted device Repealed
  21. 19EU declaration of conformity Repealed
  22. 20CE marking of conformity Repealed
  23. 21Devices for special purposes Repealed
  24. 22Systems and procedure packs Repealed
  25. 23Parts and components Repealed
  26. 24Free movement Repealed
  27. 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
  28. 25Identification within the supply chain Repealed
  29. 26Medical devices nomenclature Repealed
  30. 27Unique Device Identification system Repealed
  31. 28UDI database Repealed
  32. 29Registration of devices Repealed
  33. 30Electronic system for registration of economic operators Repealed
  34. 31Registration of manufacturers, authorised representatives and importers Repealed
  35. 32Summary of safety and clinical performance Repealed
  36. 33European database on medical devices Repealed
  37. 34Functionality of Eudamed Repealed
  38. Chapter IV: NOTIFIED BODIES Repealed
  39. 35Authorities responsible for notified bodies Repealed
  40. 36Requirements relating to notified bodies Repealed
  41. 37Subsidiaries and subcontracting Repealed
  42. 38Application by conformity assessment bodies for designation Repealed
  43. 39Assessment of the application Repealed
  44. 40Nomination of experts for joint assessment of applications for notification Repealed
  45. 41Language requirements Repealed
  46. 42Designation and notification procedure Repealed
  47. 43Identification number and list of notified bodies Repealed
  48. 44Monitoring and re-assessment of notified bodies Repealed
  49. 45Review of notified body assessment of technical documentation and clinical evaluation documentation Repealed
  50. 46Changes to designations and notifications Repealed
  51. 47Challenge to the competence of notified bodies Repealed
  52. 48Peer review and exchange of experience between authorities responsible for notified bodies Repealed
  53. 49Coordination of notified bodies Repealed
  54. 50List of standard fees Repealed
  55. Chapter V: CLASSIFICATION AND CONFORMITY ASSESSMENT Repealed
  56. Classification Repealed
  57. 51Classification of devices Repealed
  58. Conformity assessment Repealed
  59. 52Conformity assessment procedures Repealed
  60. 53Involvement of notified bodies in conformity assessment procedures Repealed
  61. 54Clinical evaluation consultation procedure for certain class III and class IIb devices Repealed
  62. 55Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices Repealed
  63. 56Certificates of conformity Repealed
  64. 57Electronic system on notified bodies and on certificates of conformity Repealed
  65. 58Voluntary change of notified body Repealed
  66. 59Derogation from the conformity assessment procedures Repealed
  67. 60Certificate of free sale Repealed
  68. Chapter VI: CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS Repealed
  69. 61Clinical evaluation Repealed
  70. 62General requirements regarding clinical investigations conducted to demonstrate conformity of devices Repealed
  71. 63Informed consent Repealed
  72. 64Clinical investigations on incapacitated subjects Repealed
  73. 65Clinical investigations on minors Repealed
  74. 66Clinical investigations on pregnant or breastfeeding women Repealed
  75. 67Additional national measures Repealed
  76. 68Clinical investigations in emergency situations Repealed
  77. 69Damage compensation Repealed
  78. 70Application for clinical investigations Repealed
  79. 71Assessment by Member States Repealed
  80. 72Conduct of a clinical investigation Repealed
  81. 73Electronic system on clinical investigations Repealed
  82. 74Clinical investigations regarding devices bearing the CE marking Repealed
  83. 75Substantial modifications to clinical investigations Repealed
  84. 76Corrective measures to be taken by Member States and information exchange between Member States Repealed
  85. 77Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination Repealed
  86. 78Coordinated assessment procedure for clinical investigations Repealed
  87. 79Review of coordinated assessment procedure Repealed
  88. 80Recording and reporting of adverse events that occur during clinical investigations Repealed
  89. 81Implementing acts Repealed
  90. 82Requirements regarding other clinical investigations Repealed
  91. Chapter VII: POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE Repealed
  92. Post-market surveillance Repealed
  93. 83Post-market surveillance system of the manufacturer Repealed
  94. 84Post-market surveillance plan Repealed
  95. 85Post-market surveillance report Repealed
  96. 86Periodic safety update report Repealed
  97. Vigilance Repealed
  98. 87Reporting of serious incidents and field safety corrective actions Repealed
  99. 88Trend reporting Repealed
  100. 89Analysis of serious incidents and field safety corrective actions Repealed
  101. 90Analysis of vigilance data Repealed
  102. 91Implementing acts Repealed
  103. 92Electronic system on vigilance and on post-market surveillance Repealed
  104. Market surveillance Repealed
  105. 93Market surveillance activities Repealed
  106. 94Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance Repealed
  107. 95Procedure for dealing with devices presenting an unacceptable risk to health and safety Repealed
  108. 96Procedure for evaluating national measures at Union level Repealed
  109. 97Other non-compliance Repealed
  110. 98Preventive health protection measures Repealed
  111. 99Good administrative practice Repealed
  112. 100Electronic system on market surveillance Repealed
  113. Chapter VIII: COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS Repealed
  114. 101Competent authorities Repealed
  115. 102Cooperation Repealed
  116. 103Medical Device Coordination Group Repealed
  117. 104Support by the Commission Repealed
  118. 105Tasks of the MDCG Repealed
  119. 106Provision of scientific, technical and clinical opinions and advice Repealed
  120. 107Conflict of interests Repealed
  121. 108Device registers and databanks Repealed
  122. Chapter IX: CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES Repealed
  123. 109Confidentiality Repealed
  124. 110Data protection Repealed
  125. 111Levying of fees Repealed
  126. 112Funding of activities related to designation and monitoring of notified bodies Repealed
  127. 113Penalties Repealed
  128. Chapter X: FINAL PROVISIONS Repealed
  129. 114Committee procedure Repealed
  130. 115Exercise of the delegation Repealed
  131. 116Separate delegated acts for different delegated powers Repealed
  132. 117Amendment to Directive 2001/83/EC Repealed
  133. 118Amendment to Regulation (EC) No 178/2002 Repealed
  134. 119Amendment to Regulation (EC) No 1223/2009 Repealed
  135. 120Transitional provisions Repealed
  136. 121Evaluation Repealed
  137. 122Repeal Repealed
  138. 123Entry into force and date of application Repealed
  139. Signature
  140. Annex I: GENERAL SAFETY AND PERFORMANCE REQUIREMENTS Repealed
  141. GENERAL REQUIREMENTS Repealed
  142. 1Division 1 Repealed
  143. 2Division 2 Repealed
  144. 3Division 3 Repealed
  145. 4Division 4 Repealed
  146. 5Division 5 Repealed
  147. 6Division 6 Repealed
  148. 7Division 7 Repealed
  149. 8Division 8 Repealed
  150. 9Division 9 Repealed
  151. REQUIREMENTS REGARDING DESIGN AND MANUFACTURE Repealed
  152. Chemical, physical and biological properties Repealed
  153. 10.1Division 10.1 Repealed
  154. 10.2Division 10.2 Repealed
  155. 10.3Division 10.3 Repealed
  156. Substances Repealed
  157. 10.4.1Design and manufacture of devices Repealed
  158. 10.4.2Justification regarding the presence of CMR and/or endocrine-disrupting substances Repealed
  159. 10.4.3Guidelines on phthalates Repealed
  160. 10.4.4Guidelines on other CMR and endocrine-disrupting substances Repealed
  161. 10.4.5Labelling Repealed
  162. 10.5Division 10.5 Repealed
  163. 10.6Division 10.6 Repealed
  164. Infection and microbial contamination Repealed
  165. 11.1Division 11.1 Repealed
  166. 11.2Division 11.2 Repealed
  167. 11.3Division 11.3 Repealed
  168. 11.4Division 11.4 Repealed
  169. 11.5Division 11.5 Repealed
  170. 11.6Division 11.6 Repealed
  171. 11.7Division 11.7 Repealed
  172. 11.8Division 11.8 Repealed
  173. 12Division 12 Repealed
  174. 12.1Division 12.1 Repealed
  175. 12.2Division 12.2 Repealed
  176. Devices incorporating materials of biological origin Repealed
  177. 13.1Division 13.1 Repealed
  178. 13.2Division 13.2 Repealed
  179. 13.3Division 13.3 Repealed
  180. Construction of devices and interaction with their environment Repealed
  181. 14.1Division 14.1 Repealed
  182. 14.2Division 14.2 Repealed
  183. 14.3Division 14.3 Repealed
  184. 14.4Division 14.4 Repealed
  185. 14.5Division 14.5 Repealed
  186. 14.6Division 14.6 Repealed
  187. 14.7Division 14.7 Repealed
  188. Devices with a diagnostic or measuring function Repealed
  189. 15.1Division 15.1 Repealed
  190. 15.2Division 15.2 Repealed
  191. Protection against radiation Repealed
  192. 16.1General Repealed
  193. 16.2Intended radiation Repealed
  194. 16.3Division 16.3 Repealed
  195. 16.4Ionising radiation Repealed
  196. Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves Repealed
  197. 17.1Division 17.1 Repealed
  198. 17.2Division 17.2 Repealed
  199. 17.3Division 17.3 Repealed
  200. 17.4Division 17.4 Repealed
  201. Active devices and devices connected to them Repealed
  202. 18.1Division 18.1 Repealed
  203. 18.2Division 18.2 Repealed
  204. 18.3Division 18.3 Repealed
  205. 18.4Division 18.4 Repealed
  206. 18.5Division 18.5 Repealed
  207. 18.6Division 18.6 Repealed
  208. 18.7Division 18.7 Repealed
  209. 18.8Division 18.8 Repealed
  210. Particular requirements for active implantable devices Repealed
  211. 19.1Division 19.1 Repealed
  212. 19.2Division 19.2 Repealed
  213. 19.3Division 19.3 Repealed
  214. 19.4Division 19.4 Repealed
  215. Protection against mechanical and thermal risks Repealed
  216. 20.1Division 20.1 Repealed
  217. 20.2Division 20.2 Repealed
  218. 20.3Division 20.3 Repealed
  219. 20.4Division 20.4 Repealed
  220. 20.5Division 20.5 Repealed
  221. 20.6Division 20.6 Repealed
  222. Protection against the risks posed to the patient or user by devices supplying energy or substances Repealed
  223. 21.1Division 21.1 Repealed
  224. 21.2Division 21.2 Repealed
  225. 21.3Division 21.3 Repealed
  226. Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons Repealed
  227. 22.1Division 22.1 Repealed
  228. 22.2Division 22.2 Repealed
  229. 22.3Division 22.3 Repealed
  230. REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE Repealed
  231. Label and instructions for use Repealed
  232. 23.1General requirements regarding the information supplied by the manufacturer Repealed
  233. 23.2Information on the label Repealed
  234. 23.3Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’) Repealed
  235. 23.4Information in the instructions for use Repealed
  236. Annex IITECHNICAL DOCUMENTATION Repealed
  237. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES Repealed
  238. 1.1Device description and specification Repealed
  239. 1.2Reference to previous and similar generations of the device Repealed
  240. 2INFORMATION TO BE SUPPLIED BY THE MANUFACTURER Repealed
  241. 3DESIGN AND MANUFACTURING INFORMATION Repealed
  242. 4GENERAL SAFETY AND PERFORMANCE REQUIREMENTS Repealed
  243. 5BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT Repealed
  244. 6PRODUCT VERIFICATION AND VALIDATION Repealed
  245. Annex IIITECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE Repealed
  246. 1Division 1 Repealed
  247. 2Division 2 Repealed
  248. Annex IVEU DECLARATION OF CONFORMITY Repealed
  249. Annex V: CE MARKING OF CONFORMITY Repealed
  250. 1The CE marking shall consist of the initials ‘CE’ taking the following form: Repealed
  251. 2Division 2 Repealed
  252. 3Division 3 Repealed
  253. Annex VI: 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 Repealed
  254. PART AINFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31 Repealed
  255. PART BCORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29 Repealed
  256. THE UDI SYSTEM Repealed
  257. Definitions Repealed
  258. Automatic identification and data capture (‘AIDC’) Repealed
  259. Basic UDI-DI Repealed
  260. Unit of Use DI Repealed
  261. Configurable device Repealed
  262. Configuration Repealed
  263. UDI-DI Repealed
  264. Human Readable Interpretation (‘HRI’) Repealed
  265. Packaging levels Repealed
  266. UDI-PI Repealed
  267. Radio Frequency Identification RFID Repealed
  268. Shipping containers Repealed
  269. Unique Device Identifier (‘UDI’) Repealed
  270. UDI carrier Repealed
  271. General requirements Repealed
  272. 2.1Division 2.1 Repealed
  273. 2.2Division 2.2 Repealed
  274. 2.3Division 2.3 Repealed
  275. 2.4Division 2.4 Repealed
  276. The UDI Repealed
  277. 3.1Division 3.1 Repealed
  278. 3.2Division 3.2 Repealed
  279. 3.3Division 3.3 Repealed
  280. 3.4Division 3.4 Repealed
  281. 3.5Division 3.5 Repealed
  282. 3.6Division 3.6 Repealed
  283. 3.7Division 3.7 Repealed
  284. 3.8Division 3.8 Repealed
  285. 3.9Division 3.9 Repealed
  286. 3.10Division 3.10 Repealed
  287. UDI carrier Repealed
  288. 4.1Division 4.1 Repealed
  289. 4.2Division 4.2 Repealed
  290. 4.3Division 4.3 Repealed
  291. 4.4Division 4.4 Repealed
  292. 4.5Division 4.5 Repealed
  293. 4.6Division 4.6 Repealed
  294. 4.7Division 4.7 Repealed
  295. 4.8Division 4.8 Repealed
  296. 4.9Division 4.9 Repealed
  297. 4.10Division 4.10 Repealed
  298. 4.11Division 4.11 Repealed
  299. 4.12Division 4.12 Repealed
  300. 4.13Division 4.13 Repealed
  301. 4.14Division 4.14 Repealed
  302. 4.15Division 4.15 Repealed
  303. General principles of the UDI database Repealed
  304. 5.1Division 5.1 Repealed
  305. 5.2Division 5.2 Repealed
  306. 5.3Division 5.3 Repealed
  307. 5.4Division 5.4 Repealed
  308. 5.5Division 5.5 Repealed
  309. 5.6Division 5.6 Repealed
  310. 5.7Division 5.7 Repealed
  311. 5.8Division 5.8 Repealed
  312. 5.9Division 5.9 Repealed
  313. 5.10Division 5.10 Repealed
  314. 5.11Division 5.11 Repealed
  315. Rules for specific device types Repealed
  316. 6.1Division 6.1 Repealed
  317. Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses Repealed
  318. 6.2.1Division 6.2.1 Repealed
  319. 6.2.2Division 6.2.2 Repealed
  320. Systems and procedure packs as referred to in Article 22 Repealed
  321. 6.3.1Division 6.3.1 Repealed
  322. 6.3.2Division 6.3.2 Repealed
  323. 6.3.3Division 6.3.3 Repealed
  324. Configurable devices: Repealed
  325. 6.4.1Division 6.4.1 Repealed
  326. 6.4.2Division 6.4.2 Repealed
  327. 6.4.3Division 6.4.3 Repealed
  328. 6.4.4Division 6.4.4 Repealed
  329. 6.4.5Division 6.4.5 Repealed
  330. Device Software Repealed
  331. 6.5.1UDI assignment Criteria Repealed
  332. 6.5.2Division 6.5.2 Repealed
  333. 6.5.3Division 6.5.3 Repealed
  334. 6.5.4UDI placement criteria for software Repealed
  335. Annex VII: REQUIREMENTS TO BE MET BY NOTIFIED BODIES Repealed
  336. ORGANISATIONAL AND GENERAL REQUIREMENTS Repealed
  337. Legal status and organisational structure Repealed
  338. 1.1.1Division 1.1.1 Repealed
  339. 1.1.2Division 1.1.2 Repealed
  340. 1.1.3Division 1.1.3 Repealed
  341. 1.1.4Division 1.1.4 Repealed
  342. 1.1.5Division 1.1.5 Repealed
  343. 1.1.6Division 1.1.6 Repealed
  344. Independence and impartiality Repealed
  345. 1.2.1Division 1.2.1 Repealed
  346. 1.2.2Division 1.2.2 Repealed
  347. 1.2.3Division 1.2.3 Repealed
  348. 1.2.4Division 1.2.4 Repealed
  349. 1.2.5Division 1.2.5 Repealed
  350. 1.2.6Division 1.2.6 Repealed
  351. 1.2.7Division 1.2.7 Repealed
  352. 1.2.8Division 1.2.8 Repealed
  353. 1.2.9Division 1.2.9 Repealed
  354. Confidentiality Repealed
  355. 1.3.1Division 1.3.1 Repealed
  356. 1.3.2Division 1.3.2 Repealed
  357. Liability Repealed
  358. 1.4.1Division 1.4.1 Repealed
  359. 1.4.2Division 1.4.2 Repealed
  360. 1.5Financial requirements Repealed
  361. Participation in coordination activities Repealed
  362. 1.6.1Division 1.6.1 Repealed
  363. 1.6.2Division 1.6.2 Repealed
  364. QUALITY MANAGEMENT REQUIREMENTS Repealed
  365. 2.1Division 2.1 Repealed
  366. 2.2Division 2.2 Repealed
  367. 2.3Division 2.3 Repealed
  368. 2.4Division 2.4 Repealed
  369. RESOURCE REQUIREMENTS Repealed
  370. General Repealed
  371. 3.1.1Division 3.1.1 Repealed
  372. 3.1.2Division 3.1.2 Repealed
  373. 3.1.3Division 3.1.3 Repealed
  374. Qualification criteria in relation to personnel Repealed
  375. 3.2.1Division 3.2.1 Repealed
  376. 3.2.2Division 3.2.2 Repealed
  377. 3.2.3Division 3.2.3 Repealed
  378. 3.2.4Division 3.2.4 Repealed
  379. 3.2.5Division 3.2.5 Repealed
  380. 3.2.6Division 3.2.6 Repealed
  381. 3.2.7Division 3.2.7 Repealed
  382. Documentation of qualification, training and authorisation of personnel Repealed
  383. 3.3.1Division 3.3.1 Repealed
  384. 3.3.2Division 3.3.2 Repealed
  385. Subcontractors and external experts Repealed
  386. 3.4.1Division 3.4.1 Repealed
  387. 3.4.2Division 3.4.2 Repealed
  388. 3.4.3Division 3.4.3 Repealed
  389. Monitoring of competences, training and exchange of experience Repealed
  390. 3.5.1Division 3.5.1 Repealed
  391. 3.5.2Division 3.5.2 Repealed
  392. PROCESS REQUIREMENTS Repealed
  393. 4.1General Repealed
  394. 4.2Notified body quotations and pre-application activities Repealed
  395. 4.3Application review and contract Repealed
  396. 4.4Allocation of resources Repealed
  397. Conformity assessment activities Repealed
  398. 4.5.1General Repealed
  399. 4.5.2Quality management system auditing Repealed
  400. Product verification Repealed
  401. Assessment of the technical documentation Repealed
  402. Type-examinations Repealed
  403. Verification by examination and testing of every product Repealed
  404. 4.5.4Pre-clinical evaluation assessment Repealed
  405. 4.5.5Clinical evaluation assessment Repealed
  406. 4.5.6Specific Procedures Repealed
  407. 4.6Reporting Repealed
  408. 4.7Final review Repealed
  409. 4.8Decisions and Certifications Repealed
  410. 4.9Changes and modifications Repealed
  411. 4.10Surveillance activities and post-certification monitoring Repealed
  412. 4.11Re-certification Repealed
  413. Annex VIII: CLASSIFICATION RULES Repealed
  414. DEFINITIONS SPECIFIC TO CLASSIFICATION RULES Repealed
  415. DURATION OF USE Repealed
  416. 1.1Division 1.1 Repealed
  417. 1.2Division 1.2 Repealed
  418. 1.3Division 1.3 Repealed
  419. INVASIVE AND ACTIVE DEVICES Repealed
  420. 2.1Division 2.1 Repealed
  421. 2.2Division 2.2 Repealed
  422. 2.3Division 2.3 Repealed
  423. 2.4Division 2.4 Repealed
  424. 2.5Division 2.5 Repealed
  425. 2.6Division 2.6 Repealed
  426. 2.7Division 2.7 Repealed
  427. 2.8Division 2.8 Repealed
  428. IMPLEMENTING RULES Repealed
  429. 3.1Division 3.1 Repealed
  430. 3.2Division 3.2 Repealed
  431. 3.3Division 3.3 Repealed
  432. 3.4Division 3.4 Repealed
  433. 3.5Division 3.5 Repealed
  434. 3.6Division 3.6 Repealed
  435. 3.7Division 3.7 Repealed
  436. CLASSIFICATION RULES Repealed
  437. NON-INVASIVE DEVICES Repealed
  438. 4.1Rule 1 Repealed
  439. 4.2Rule 2 Repealed
  440. 4.3Rule 3 Repealed
  441. 4.4Rule 4 Repealed
  442. INVASIVE DEVICES Repealed
  443. 5.1Rule 5 Repealed
  444. 5.2Rule 6 Repealed
  445. 5.3Rule 7 Repealed
  446. 5.4Rule 8 Repealed
  447. ACTIVE DEVICES Repealed
  448. 6.1Rule 9 Repealed
  449. 6.2Rule 10 Repealed
  450. 6.3Rule 11 Repealed
  451. 6.4Rule 12 Repealed
  452. 6.5Rule 13 Repealed
  453. SPECIAL RULES Repealed
  454. 7.1Rule 14 Repealed
  455. 7.2Rule 15 Repealed
  456. 7.3Rule 16 Repealed
  457. 7.4Rule 17 Repealed
  458. 7.5Rule 18 Repealed
  459. 7.6Rule 19 Repealed
  460. 7.7Rule 20 Repealed
  461. 7.8Rule 21 Repealed
  462. 7.9Rule 22 Repealed
  463. Annex IX: CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION Repealed
  464. QUALITY MANAGEMENT SYSTEM Repealed
  465. 1Division 1 Repealed
  466. Quality management system assessment Repealed
  467. 2.1Division 2.1 Repealed
  468. 2.2Division 2.2 Repealed
  469. 2.3Audit Repealed
  470. 2.4Division 2.4 Repealed
  471. Surveillance assessment Repealed
  472. 3.1Division 3.1 Repealed
  473. 3.2Division 3.2 Repealed
  474. 3.3Division 3.3 Repealed
  475. 3.4Division 3.4 Repealed
  476. 3.5Division 3.5 Repealed
  477. 3.6Division 3.6 Repealed
  478. 3.7Division 3.7 Repealed
  479. ASSESSMENT OF THE TECHNICAL DOCUMENTATION Repealed
  480. Assessment of the technical documentation applicable to class III devices and to the class IIb devices referred to in the second subparagraph of Article 52(4) Repealed
  481. 4.1Division 4.1 Repealed
  482. 4.2Division 4.2 Repealed
  483. 4.3Division 4.3 Repealed
  484. 4.4Division 4.4 Repealed
  485. 4.5Division 4.5 Repealed
  486. 4.6Division 4.6 Repealed
  487. 4.7Division 4.7 Repealed
  488. 4.8Division 4.8 Repealed
  489. 4.9Division 4.9 Repealed
  490. 4.10Division 4.10 Repealed
  491. Specific additional procedures Repealed
  492. 5.1Assessment procedure for certain class III and class IIb devices Repealed
  493. 5.2Procedure in the case of devices incorporating a medicinal substance Repealed
  494. Procedure in the case of devices manufactured utilising, or incorporating, tissues or cells of human or animal origin, or their derivatives, that are non-viable or rendered non-viable Repealed
  495. 5.3.1Tissues or cells of human origin or their derivatives Repealed
  496. 5.3.2Tissues or cells of animal origin or their derivatives Repealed
  497. 5.4Procedure in the case of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body Repealed
  498. 6Batch verification in the case of devices incorporating, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma as referred to in Article 1(8) Repealed
  499. ADMINISTRATIVE PROVISIONS Repealed
  500. 7Division 7 Repealed
  501. 8Division 8 Repealed
  502. Annex X: CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION Repealed
  503. 1Division 1 Repealed
  504. 2Application Repealed
  505. 3Assessment Repealed
  506. 4Certificate Repealed
  507. Changes to the type Repealed
  508. 5.1Division 5.1 Repealed
  509. 5.2Division 5.2 Repealed
  510. 5.3Division 5.3 Repealed
  511. 6Specific additional procedures Repealed
  512. 7Administrative provisions Repealed
  513. Annex XI: CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION Repealed
  514. 1Division 1 Repealed
  515. 2Division 2 Repealed
  516. 3Division 3 Repealed
  517. PRODUCTION QUALITY ASSURANCE Repealed
  518. 4Division 4 Repealed
  519. 5Division 5 Repealed
  520. Quality management system Repealed
  521. 6.1Division 6.1 Repealed
  522. 6.2Division 6.2 Repealed
  523. 6.3Division 6.3 Repealed
  524. 6.4Division 6.4 Repealed
  525. 7Surveillance Repealed
  526. 8Division 8 Repealed
  527. 9Administrative provisions Repealed
  528. Application to class IIa devices Repealed
  529. 10.1Division 10.1 Repealed
  530. 10.2Division 10.2 Repealed
  531. 10.3Division 10.3 Repealed
  532. 10.4Division 10.4 Repealed
  533. 10.5Division 10.5 Repealed
  534. PRODUCT VERIFICATION Repealed
  535. 11Division 11 Repealed
  536. 12Division 12 Repealed
  537. 13Division 13 Repealed
  538. 14Division 14 Repealed
  539. Verification by examination and testing of every product Repealed
  540. 15.1Division 15.1 Repealed
  541. 15.2Division 15.2 Repealed
  542. 16Division 16 Repealed
  543. 17Administrative provisions Repealed
  544. Application to class IIa devices Repealed
  545. 18.1Division 18.1 Repealed
  546. 18.2Division 18.2 Repealed
  547. 18.3Division 18.3 Repealed
  548. 18.4Division 18.4 Repealed
  549. Annex XII: CERTIFICATES ISSUED BY A NOTIFIED BODY Repealed
  550. GENERAL REQUIREMENTS Repealed
  551. 1Division 1 Repealed
  552. 2Division 2 Repealed
  553. 3Division 3 Repealed
  554. 4The scope of the certificates shall unambiguously identify the device or devices covered: Repealed
  555. 5Division 5 Repealed
  556. 6Division 6 Repealed
  557. 7Division 7 Repealed
  558. 8Division 8 Repealed
  559. CHAPTER IIMINIMUM CONTENT OF THE CERTIFICATES Repealed
  560. Annex XIII: PROCEDURE FOR CUSTOM-MADE DEVICES Repealed
  561. 1For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following information: Repealed
  562. 2Division 2 Repealed
  563. 3Division 3 Repealed
  564. 4The 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. Repealed
  565. 5Division 5 Repealed
  566. Annex XIV: CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP Repealed
  567. CLINICAL EVALUATION Repealed
  568. 1Division 1 Repealed
  569. 2Division 2 Repealed
  570. 3Division 3 Repealed
  571. 4Division 4 Repealed
  572. POST-MARKET CLINICAL FOLLOW-UP Repealed
  573. 5Division 5 Repealed
  574. 6Division 6 Repealed
  575. 6.1Division 6.1 Repealed
  576. 6.2Division 6.2 Repealed
  577. 7Division 7 Repealed
  578. 8Division 8 Repealed
  579. Annex XV: CLINICAL INVESTIGATIONS Repealed
  580. GENERAL REQUIREMENTS Repealed
  581. 1Ethical principles Repealed
  582. Methods Repealed
  583. 2.1Division 2.1 Repealed
  584. 2.2Division 2.2 Repealed
  585. 2.3Division 2.3 Repealed
  586. 2.4Division 2.4 Repealed
  587. 2.5Division 2.5 Repealed
  588. 2.6Division 2.6 Repealed
  589. 2.7Division 2.7 Repealed
  590. 2.8Division 2.8 Repealed
  591. CHAPTER IIDOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION Repealed
  592. OTHER OBLIGATIONS OF THE SPONSOR Repealed
  593. 1Division 1 Repealed
  594. 2Division 2 Repealed
  595. 3Division 3 Repealed
  596. 4Division 4 Repealed
  597. 5Division 5 Repealed
  598. 6Division 6 Repealed
  599. 7Division 7 Repealed
  600. Annex XVI: LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) Repealed
  601. 1Division 1 Repealed
  602. 2Division 2 Repealed
  603. 3Division 3 Repealed
  604. 4Division 4 Repealed
  605. 5Division 5 Repealed
  606. 6Division 6 Repealed
  607. Annex XVIICORRELATION TABLE Repealed