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Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

EU Directive 1993/42 · Adopted 14 June 1993 · 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.

Council Directive 93/42/EEC

of 14 June 1993

concerning medical devices

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,

Having regard to the proposal from the Commissionf1,

In cooperation with the European Parliamentf2,

Having regard to the opinion of the Economic and Social Committeef3,

Whereas measures should be adopted in the context of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;

Whereas the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance characteristics of medical devices are different; whereas the certification and inspection procedures for such devices differ from one Member State to another; whereas such disparities constitute barriers to trade within the Community;

Whereas the national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonized in order to guarantee the free movement of such devices within the internal market;

Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to manage the funding of public health and sickness insurance schemes relating directly or indirectly to such devices; whereas, therefore, the provisions do not affect the ability of the Member States to implement the abovementioned measures provided Community law is complied with;

Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive;

Whereas certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal productsf4; whereas, in such cases, the placing on the market of the medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; whereas if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral unit which is intended exclusively for use in the given combination and which is not reusable, that single-unit product shall be governed by Directive 65/65/EEC; whereas a distinction must be drawn between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately, may be considered to be a medicinal substance within the meaning of Directive 65/65/EEC; whereas in such cases, if the substances incorporated in the medical devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is governed by this Directive; whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal productsf5;

Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to ‘minimizing’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety;

Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardizationf6, rules regarding the design and manufacture of medical devices must be confined to the provisions required to meet the essential requirements; whereas, because they are essential, such requirements should replace the corresponding national provisions; whereas the essential requirements should be applied with discretion to take account of the technological level existing at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety;

Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devicesf7 is the first case of application of the new approach to the field of medical devices; whereas in the interest of uniform Community rules applicable to all medical devices, this Directive is based largely on the provisions of Directive 90/385/EEC; whereas for the same reasons Directive 90/385/EEC must be amended to insert the general provisions laid down in this Directive;

Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices; whereas this Directive should contain specific rules on this subject with regard to Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibilityf8;

Whereas this Directive should include requirements regarding the design and manufacture of devices emitting ionizing radiation; whereas this Directive does not affect the authorization required by Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiationf9, nor application of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatmentf10; whereas Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at workf11 and the specific directives on the same subject should continue to apply;

Whereas, in order to demonstrate conformity with the essential requirements and to enable conformity to be verified, it is desirable to have harmonized European standards to protect against the risks associated with the design, manufacture and packaging of medical devices; whereas such harmonized European standards are drawn up by private-law bodies and should retain their status as non-mandatory texts; whereas, to this end, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of harmonized standards in accordance with the general guidelines on cooperation between the Commission and these two bodies signed on 13 November 1984;

Whereas, for the purpose of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted, on a mandate from the Commission, by either or both of these bodies in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulationsf12, and pursuant to the abovementioned general guidelines; whereas with regard to possible amendment of the harmonized standards, the Commission should be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the measures to be taken must be defined in line with procedure I, as laid down in Council Decision 87/373/EECf13; whereas, for specific fields, what already exists in the form of European Pharmacopoeia monographs should be incorporated within the framework of this Directive; whereas, therefore, several European Pharmacopoeia monographs may be considered equal to the abovementioned harmonized standards;

Whereas, in Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directivesf14, the Council has laid down harmonized conformity assessment procedures; whereas the application of these modules to medical devices enables the responsibility of manufacturers and notified bodies to be determined during conformity assessment procedures on the basis of the type of devices concerned; whereas the details added to these modules are justified by the nature of the verification required for medical devices;

Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group the devices into four product classes; whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices; whereas the conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified body should be compulsory at the production stage; whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market;

Whereas in cases where the conformity of the devices can be assessed under the responsibility of the manufacturer the competent authorities must be able, particularly in emergencies, to contact a person responsible for placing the device on the market and established in the Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose;

Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose;

Whereas, in the fight against AIDS and in the light of the conclusions of the Council adopted on 16 May 1989 regarding future activities on AIDS prevention and control at Community levelf15, medical devices used for protection against the HIV virus must afford a high level of protection; whereas the design and manufacture of such products should be verified by a notified body;

Whereas the classification rules generally enable medical devices to be appropriately classified; whereas, in view of the diverse nature of the devices and technological progress in this field, steps must be taken to include amongst the implementing powers conferred on the Commission the decisions to be taken with regard to the proper classification or reclassification of the devices or, where appropriate, the adjustment of the classification rules themselves; whereas since these issues are closely connected with the protection of health, it is appropriate that these decisions should come under procedure IIIa, as provided for in Directive 87/373/EEC;

Whereas the confirmation of complicance with the essential requirements may mean that clinical investigations have to be carried out under the responsibility of the manufacturer; whereas, for the purpose of carrying out the clinical investigations, appropriate means have to be specified for the protection of public health and public order;

Whereas the protection of health and the associated controls may be made more effective by means of medical device vigilance systems which are integrated at Community level;

Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on clinical mercury-in-glass, maximum reading thermometersf16; whereas the abovementioned Directive must therefore be repealed; whereas for the same reasons Council Directive 84/539/EEC on 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicinef17 must be amended,

HAS ADOPTED THIS DIRECTIVE:

Annotations to the whole text

Footnotes

f1

OJ No C 237, 12.9.1991 and OJ No C 251, 28.9.1992, p. 40.

f2

OJ No C 150, 31.5.1993 and OJ No C 176, 28.6.1993.

f3

OJ No C 79, 30.3.1992, p. 1.

f4

OJ No 22, 9.6.1965, p. 369/65. Directive as last amended by Directive 92/27/EEC (OJ No L 113, 30.4.1992, p. 8).

f5

OJ No L 147, 9.6.1975, p. 1. Directive as last amended by Directive 91/507/EEC (OJ No L 270, 26.9.1991, p. 32).

f6

OJ No C 136, 4.6.1985, p. 1.

f7

OJ No L 189, 20.7.1990, p. 17.

f8

OJ No L 139, 23.5.1989, p. 19. Directive as last amended by Directive 92/31/EEC (OJ No L 126, 12.5.1992, p. 11).

f9

OJ No L 246, 17.9.1980, p. 1. Directive as last amended by Directive 84/467/Euratom (OJ No L 265, 5.10.1984, p. 4).

f10

OJ No L 265, 5.10.1984, p. 1.

f11

OJ No L 183, 29.6.1989, p. 1.

f12

OJ No L 109, 26.4.1983, p. 8. Directive as last amended by Commission Decision 92/400/EEC (OJ No L 221, 6.8.1992, p. 55).

f13

OJ No L 197, 18.7.1987, p. 33.

f14

OJ No L 147, 9.6.1975, p. 1. Directive as last amended by Directive 91/507/EEC (OJ No L 270, 26.9.1991, p. 32).

f15

OJ No C 185, 22.7.1989, p. 8.

f16

OJ No L 262, 27.9.1976, p. 139. Directive as last amended by Directive 84/414/EEC (OJ No L 228, 25.8.1984, p. 25).

f17

OJ No L 300, 19.11.1984, p. 179. Directive as amended by the Act of Accession of Spain and Portugal.

Contents

  1. 1Definitions, scope
  2. 2Placing on the market and putting into service
  3. 3Essential requirements
  4. 4Free movement, devices intended for special purposes
  5. 5Reference to standards
  6. 6Committee on Standards and Technical Regulations
  7. 7Article 7
  8. 8Safeguard clause
  9. 9Classification
  10. 10Information on incidents occuring following placing of devices on the market
  11. 11Conformity assessment procedures
  12. 12Particular procedure for systems and procedure packs and procedure for sterilisation
  13. 12aReprocessing of medical devices
  14. 13Decisions with regard to classification and derogation clause
  15. 14Registration of persons responsible for placing devices on the market
  16. 14aEuropean databank
  17. 14bParticular health monitoring measures
  18. 15Clinical investigation
  19. 16Notified bodies
  20. 17CE marking
  21. 18Wrongly affixed CE marking
  22. 19Decision in respect of refusal or restriction
  23. 20Confidentiality
  24. 20aCooperation
  25. 21Repeal and amendment of Directives
  26. 22Implementation, transitional provisions
  27. 23Article 23
  28. Annex I: ESSENTIAL REQUIREMENTS
  29. GENERAL REQUIREMENTS
  30. 1Division 1
  31. 2Division 2
  32. 3Division 3
  33. 4Division 4
  34. 5Division 5
  35. 6Division 6
  36. 6aDivision 6a
  37. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
  38. Chemical, physical and biological properties
  39. 7.1Division 7.1
  40. 7.2Division 7.2
  41. 7.3Division 7.3
  42. 7.4Division 7.4
  43. 7.5Division 7.5
  44. 7.6Division 7.6
  45. Infection and microbial contamination
  46. 8.1Division 8.1
  47. 8.2Division 8.2
  48. 8.3Division 8.3
  49. 8.4Division 8.4
  50. 8.5Division 8.5
  51. 8.6Division 8.6
  52. 8.7Division 8.7
  53. Construction and environmental properties
  54. 9.1Division 9.1
  55. 9.2Division 9.2
  56. 9.3Division 9.3
  57. Devices with a measuring function
  58. 10.1Division 10.1
  59. 10.2Division 10.2
  60. 10.3Division 10.3
  61. Protection against radiation
  62. General
  63. 11.1.1Division 11.1.1
  64. Intended radiation
  65. 11.2.1Division 11.2.1
  66. 11.2.2Division 11.2.2
  67. Unintended radiation
  68. 11.3.1Division 11.3.1
  69. Instructions
  70. 11.4.1Division 11.4.1
  71. Ionizing radiation
  72. 11.5.1Division 11.5.1
  73. 11.5.2Division 11.5.2
  74. 11.5.3Division 11.5.3
  75. Requirements for medical devices connected to or equipped with an energy source
  76. 12.1Division 12.1
  77. 12.1aDivision 12.1a
  78. 12.2Division 12.2
  79. 12.3Division 12.3
  80. 12.4Division 12.4
  81. 12.5Division 12.5
  82. 12.6Protection against electrical risks
  83. Protection against mechanical and thermal risks
  84. 12.7.1Division 12.7.1
  85. 12.7.2Division 12.7.2
  86. 12.7.3Division 12.7.3
  87. 12.7.4Division 12.7.4
  88. 12.7.5Division 12.7.5
  89. Protection against the risks posed to the patient by energy supplies or substances
  90. 12.8.1Division 12.8.1
  91. 12.8.2Division 12.8.2
  92. 12.9The function of the controls and indicators must be clearly specified on the devices.
  93. Information supplied by the manufacturer
  94. 13.1Division 13.1
  95. 13.2Division 13.2
  96. 13.3Division 13.3
  97. 13.4Division 13.4
  98. 13.5Division 13.5
  99. 13.6Division 13.6
  100. 14Division 14 Repealed
  101. Annex II: EC DECLARATION OF CONFORMITY
  102. 1Division 1
  103. 2Division 2
  104. Quality system
  105. 3.1Division 3.1
  106. 3.2Division 3.2
  107. 3.3Division 3.3
  108. 3.4Division 3.4
  109. Examination of the design of the product
  110. 4.1Division 4.1
  111. 4.2Division 4.2
  112. 4.3Division 4.3
  113. 4.4Division 4.4
  114. Surveillance
  115. 5.1Division 5.1
  116. 5.2Division 5.2
  117. 5.3Division 5.3
  118. 5.4Division 5.4
  119. Administrative provisions
  120. 6.1Division 6.1
  121. 6.2Division 6.2 Repealed
  122. 6.3Division 6.3 Repealed
  123. Application to devices in Classes IIa and IIb.
  124. 7.1Division 7.1
  125. 7.2Division 7.2
  126. 7.3Division 7.3
  127. 7.4Division 7.4
  128. 7.5Division 7.5
  129. 8Application to the devices referred to Article 1(4a)
  130. Annex III: EC TYPE-EXAMINATION
  131. 1Division 1
  132. 2Division 2
  133. 3Division 3
  134. 4Division 4
  135. 4.1Division 4.1
  136. 4.2Division 4.2
  137. 4.3Division 4.3
  138. 4.4Division 4.4
  139. 5Division 5
  140. 6Division 6
  141. Administrative provisions
  142. 7.1Division 7.1 Repealed
  143. 7.2Division 7.2
  144. 7.3Division 7.3
  145. 7.4Division 7.4 Repealed
  146. Annex IV: EC VERIFICATION
  147. 1Division 1
  148. 2Division 2
  149. 3Division 3
  150. 4Division 4
  151. Verification by examination and testing of every product
  152. 5.1Division 5.1
  153. 5.2Division 5.2
  154. Statistical verification
  155. 6.1Division 6.1
  156. 6.2Division 6.2
  157. 6.3Division 6.3
  158. 6.4Division 6.4
  159. 7Administrative provisions
  160. 8Application to devices in Class IIa
  161. 8.1Division 8.1
  162. 8.2Division 8.2
  163. 9Application to devices referred to in Article 1(4a)
  164. Annex V: EC DECLARATION OF CONFORMITY
  165. 1Division 1
  166. 2Division 2
  167. Quality system
  168. 3.1Division 3.1
  169. 3.2Division 3.2
  170. 3.3Division 3.3
  171. 3.4Division 3.4
  172. Surveillance
  173. 4.1Division 4.1
  174. 4.2Division 4.2
  175. 4.3Division 4.3
  176. 4.4Division 4.4
  177. Administrative provisions
  178. 5.1Division 5.1
  179. 5.2Division 5.2 Repealed
  180. 6Application to devices in Class IIa
  181. 6.1Division 6.1
  182. 6.2Division 6.2
  183. 6.3Division 6.3
  184. 6.4Division 6.4
  185. 7Application to devices referred to in Article 1(4a)
  186. Annex VI: EC DECLARATION OF CONFORMITY
  187. 1Division 1
  188. 2Division 2
  189. Quality system
  190. 3.1Division 3.1
  191. 3.2Division 3.2
  192. 3.3Division 3.3
  193. 3.4Division 3.4
  194. Surveillance
  195. 4.1Division 4.1
  196. 4.2Division 4.2
  197. 4.3Division 4.3
  198. 4.4Division 4.4
  199. Administrative provisions
  200. 5.1Division 5.1
  201. 5.2Division 5.2 Repealed
  202. 6Application to devices in Class IIa
  203. 6.1Division 6.1
  204. 6.2Division 6.2
  205. 6.3Division 6.3
  206. 6.4Division 6.4
  207. Annex VII: EC DECLARATION OF CONFORMITY
  208. 1Division 1
  209. 2Division 2
  210. 3Division 3
  211. 4Division 4
  212. 5Division 5
  213. 6Application to devices in Class IIa
  214. 6.1Division 6.1
  215. Annex VIII: STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES
  216. 1Division 1
  217. 2Division 2
  218. 2.1Division 2.1
  219. 2.2Division 2.2
  220. 3Division 3
  221. 3.1Division 3.1
  222. 3.2Division 3.2
  223. 4Division 4
  224. 5Division 5
  225. Annex IX: CLASSIFICATION CRITERIA
  226. DEFINITIONS
  227. Definitions for the classification rules
  228. Duration
  229. Transient
  230. Short term
  231. Long term
  232. Invasive devices
  233. Invasive device
  234. Body orifice
  235. Surgically invasive device
  236. Implantable device
  237. 1.3Reusable surgical instrument
  238. 1.4Active medical device
  239. 1.5Active therapeutical device
  240. 1.6Active device for diagnosis
  241. 1.7Central circulatory system
  242. 1.8Central nervous system
  243. IMPLEMENTING RULES
  244. Implementing rules
  245. 2.1Division 2.1
  246. 2.2Division 2.2
  247. 2.3Division 2.3
  248. 2.4Division 2.4
  249. 2.5Division 2.5
  250. 2.6Division 2.6
  251. CLASSIFICATION
  252. Non-invasive devices
  253. 1.1Rule 1
  254. 1.2Rule 2
  255. 1.3Rule 3
  256. 1.4Rule 4
  257. Invasive devices
  258. 2.1Rule 5
  259. 2.2Rule 6
  260. 2.3Rule 7
  261. 2.4Rule 8
  262. Additional rules applicable to active devices
  263. 3.1Rule 9
  264. 3.2Rule 10
  265. Rule 11
  266. 3.3Rule 12
  267. Special Rules
  268. 4.1Rule 13
  269. 4.2Rule 14
  270. 4.3Rule 15
  271. 4.4Rule 16
  272. 4.5Rule 17
  273. 5Rule 18
  274. Annex X: CLINICAL EVALUATION
  275. General provisions
  276. 1.1Division 1.1
  277. 1.1.1Division 1.1.1
  278. 1.1.2Division 1.1.2
  279. 1.1.3Division 1.1.3
  280. 1.1aDivision 1.1a
  281. 1.1bDivision 1.1b
  282. 1.1cDivision 1.1c
  283. 1.1dDivision 1.1d
  284. 1.2Division 1.2
  285. Clinical investigations
  286. 2.1Objectives
  287. 2.2Ethical considerations
  288. Methods
  289. 2.3.1Division 2.3.1
  290. 2.3.2Division 2.3.2
  291. 2.3.3Division 2.3.3
  292. 2.3.4Division 2.3.4
  293. 2.3.5Division 2.3.5
  294. 2.3.6Division 2.3.6
  295. 2.3.7Division 2.3.7
  296. Annex XI: CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES
  297. 1Division 1
  298. 2Division 2
  299. 3Division 3
  300. 4Division 4
  301. 5Division 5
  302. 6Division 6
  303. 7Division 7
  304. Annex XIICE MARKING OF CONFORMITY