The EU medical device market process and enlightenment for the review / 中国医疗器械杂志

ABSTRACT

European Union (EU) medical device supervision system is more complete, has a lot of experiences and characteristics worth learning. This paper introduces a brief overview of the process of medical devices market in the EU, including three core medical device directives, process of obtaining CE mark, medical devices vigilance system and supervision after obtaining the CE mark, etc. Simultaneously, preliminary enlightenments of the EU medical devices supervision to our national medical devices' technical review process are discussed with the aim of providing reference for supervision, technical review unit and manufacturer.