The role of quality assurance certification in obtaining the CE mark for electro medical equipment

This paper reviews the quality system options within the Medical Devices Directive 93/42/EEC (MDD) and their applicability to manufacturers of electromedical equipment, accessories and software. This includes the relationship with the ISO 9000 and EN 46000 quality system standards. Finally, the authors describe the role of the Notified Body in certifying quality systems and how conformance with the Essential Requirements of the MDD are demonstrated in the absence of an EC Type Examination. The paper is based on the world wide experience of SGS, the world´s largest inspection, testing and certification organisation, and in particular SGS Yarsley ICS, the UK based UKAS accredited certification body and Notified Body 0120