Case 6



Case 6 : Application of the EMC Directive to Active implantable medical devices


The requirements of the 'Active implantable medical devices' Directive (90/385/EEC) are fully applicable from 1/01/1993. Member States have accepted, until 31/12/1994 the placing on the EEA market and/or the putting into service, Active implantable medical devices complying with legislation in force in their territory at 31/12/1992 (Article 16.1 of this Directive).

As a consequence, the EMC (89/336/EEC) Directive has not applied since 31/12/1994, the 'Active implantable medical devices' Directive (90/385/EEC) being a fully specific Directive.