In addition to being directed at medical devices for in
vitro diagnosis, the Commission proposal sought to
amend Council Directive 93/42/EEC of 14 June 1993
concerning medical devices (4) in order to extend its
scope to medical devices manufactured by using nonviable
tissues or substances of human origin derived
from those tissues. This amendment was not included in
Directive 98/79/EC (5) when it was adopted.