# 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 2.1

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

For custom-made devices:
the name and address of the manufacturer,
the information necessary for the identification of the product in question,
a statement affirming that the device is intended for exclusive use by a particular patient, together with his name,
the name of the duly qualified medical practitioner who drew up the prescription and, if applicable, the name of the clinic concerned,
the specific characteristics of the product revealed by the prescription,
a statement affirming that the device complies with the essential requirements given in Annex 1 and, where applicable, indicating which essential requirements have not been wholly met, together with the grounds.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/6/division/2/division/2.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-6/division-2/division-2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.