Testing for technical files: avoiding too little and too much
Clifford, A.
Medical Device Technology 9(7): 30-31
1998
ISSN/ISBN: 1048-6690 PMID: 10186981 Document Number: 494816
Since 13 June 1998, it has been mandatory for all new and existing medical devices to be CE-marked according to the Medical Device Directive. However, for certain electromedical devices full compliance with the requirements of EN 60601-1 as a means of obtaining the CE mark may not be necessary. This article looks at some of these products and explains how they may still qualify for distribution in the European medical market.