Subsection 11: Procedures to be observed by persons sterilising medical devices

Any person who sterilizes with a view to placing on the market CE-marked medical devices designed by their manufacturer to be sterilized before use or systems or kits referred to in Section 10 of this Chapter must follow, at his choice, the procedure relating to the EC declaration of conformity, full quality assurance system, or the procedure relating to the EC declaration of conformity, production quality assurance. The application of…