Europe is the world's second-largest medical device market with 500 million people, 20+ languages, 32 countries and (fortunately) only one approval process. This short video gives you a high level overview of the CE Marking process in Europe as it exists currently under the Medical Devices Directive (93/42/EEC). We discuss how devices are regulated, classification of devices, the role of your EC REP, QMS requirements and more. Read more about our European CE compliance services or download this free chart on the medical device approval process in Europe.
All documents listed below are available from the South African Department of Health. Electromedical devices fall under the scope of the Hazardous Substances Act, No...