# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 2.1

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

for custom-made devices:
the name and address of the manufacturer,
data allowing identification of the device in question,
a statement that the device is intended for exclusive use by a particular patient, together with the name of the patient,
the name of the medical practitioner or other authorized person who made out the prescription and, where applicable, the name of the clinic concerned,
the specific characteristics of the product as indicated by the prescription,
a statement that the device in question conforms to the essential requirements set out in Annex I and, where applicable, indicating which essential requirements have not been fully met, together with the grounds;

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/VIII/division/2/division/2.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-VIII/division-2/division-2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.