# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 4.2

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

carry out or arrange for the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied; if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer;

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/III/division/4/division/4.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-III/division-4/division-4.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.