Subsection 5: EC declaration of conformity, full quality assurance system.

As part of the procedure for the EC declaration of conformity, a full quality assurance system, the manufacturer must submit to an approved body for verification the quality system which he has set up for the design, manufacture and final inspection of the medical devices and the application of which must guarantee compliance with the provisions of this Title and the implementing orders which apply to them. The manufacturer submits…

For Class IIa devices, the authorized body must, as part of the assessment of the quality system, assess the technical documentation for at least one representative sample of each device subcategory in order to verify its conformity with the provisions of this Title. For Class II b devices, as part of the assessment of the quality system, the authorized body must evaluate the technical documentation for at least one representative…