# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division: Implantable device

Extent: E+W+S+N.I.

Any device which is intended:
to be totally introduced into the human body or,
to replace an epithelial surface or the surface of the eye,
by surgical intervention which is intended to remain in place after the procedure.
Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/IX/division/I/division/1/division/1.2/division/4 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-IX/division-I/division-1/division-1.2/division-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.