CATEGORY OF REFERRAL: Proposal for Directive 2. Expected date of
referral: December 1994 3. Previous Community legislation:
Directive 93/42 of 14 June 1993 on medical devices excluding devices used
for in-vitro diagnosis and active implantable devices. Related legislation
73/23, 87/404, 88/378, 89/106, 89/336, 89/392, 89/684, 90/384, 90/385
amended by 93/68, 90/396, 91/263, and 92/42.
PREVIOUS POSITION OF EP: Amendments and legislative Resolution A3-0178/92
on medical devices (OJ C150 of 15/06/1992) and EP decision on medical
devices (OJ C150 of 31/05/1993). The EP found the general tenor of the
proposal satisfactory but adopted a number of amendments, especially in
regard to restricting administrative formalities, increasing consultation
opportunities for manufacturers, and making some of the definitions more
precise.
SITUATION IN THE MEMBER STATES: no national legislation available.