# 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 14.2

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

On the sales packaging:
the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,
a description of the device,
the purpose of the device,
the relevant characteristics for its use,
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,
the conditions for transporting and staring the device,
in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/1/division/II/division/14/division/14.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-1/division-II/division-14/division-14.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.