# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 4.1: Rule 13

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

All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 2001/83/EC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class III.
All devices incorporating, as an integral part, a human blood derivative are in Class III.

---
Source: https://www.legislation.gov.uk/eudr/1993/42/annex/IX/division/III/division/4/division/4.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-IX/division-III/division-4/division-4.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.