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Council Directive 93/42/EECShow full title
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
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- Revised 11/10/20070.26 MB
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- Revised 07/12/19980.21 MB
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[F12.2. Rule 6 U.K.
All surgically invasive devices intended for transient use are in Class IIa unless they are:
intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
reusable surgical instruments, in which case they are in Class I,
intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,
intended to supply energy in the form of ionising radiation in which case they are in Class IIb,
intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,
intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.]
Textual Amendments
F1 Substituted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).
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