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Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
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All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive [F12001/83/EC], and which is liable to act on the human body with action ancillary to that of the devices, are in Class III.
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).
[F1All devices incorporating, as an integral part, a human blood derivative are in Class III.]
All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class IIb, unless they are implantable or long term invasive devices, in which case they are in Class III.
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class IIb.
All devices intended specifically to be used for disinfecting medical devices are in Class IIa. [F2Unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.]
Textual Amendments
F2 Inserted 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).
This rule does not apply to products that are intended to clean medical devices other than contact lenses by means of physical action.
[F1Devices] specifically intended for recording of X-ray diagnostic images are in Class IIa.
All devices manufactured utilizing animal tissues or derivatives rendered non-viable are Class III except where such devices are intended to come into contact with intact skin only.
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