Case 5 : Application of the EMC Directive to Medical Devices

• The requirements of the 'Medical devices' Directive (93/42/EEC) are fully applicable from 1/01/1995
• Member States will accept, until 14/06/1998, the placing on the EEA market and/or the putting into service, medical devices complying with legislation in force in their territory at 31/1/1994.

As a consequence, the manufacturer has the following choices to comply with the EMC requirements :

• From 1/01/1995 to 14/06/1998:
• Either the requirements of Directive 93/42/EEC, or
• Those of the EMC Directive (89/336/EEC), using the criteria developed in this guide.
• From 15/06/1998, the end of the transitional period, the requirements of the 93/42/EEC are mandatory. The EMC Directive (89/336/EEC) will no longer apply.

Harmonised Standards: The reference of standard EN 60601-1-1-2 has been published in the Official Journal of the European Communities; any national transposition of this European standard can be used to provide a presumption of conformity to the EMC requirements.