Medical devices incorporating stable derivates of human blood or human plasma

2001/0186(COD)
PURPOSE : to amend Council directive 93/42/EEC to include medical devices incorporating substances derived from human blood or plasma. COMMUNITY MEASURE : Directive 2001/104/EC of the European Parliament and of the Council amending Council Directive 93/42/EEC concerning medical devices. CONTENT : This directive aims at including in the scope of directive 93/42/EEC only medical devices which incorporate as an integral part, substances derived from human blood or human plasma. Medical devices incorporating other substances derived from human tissues remain excluded from the scope of the Directive. DATE OF APPLICATION : 13 June 2002 ENTRY INTO FORCE : 10 January 2002.�