# Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC), Division 14.1

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

On the sterile pack:
the method of sterilization,
an indication permitting this packaging to be recognized as such,
the name and address of the manufacturer,
a description of the device,
if the device is intended for clinical investigations, the words: ‘exclusively for clinical investigations’,
if the device is custom-made, the words ‘custom-made device’,
a declaration that the implantable device is in a sterile condition,
the month and year of manufacture,
an indication of the time limit for implanting a device safely.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/1/division/II/division/14/division/14.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-1/division-II/division-14/division-14.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.