CE technical file and 510k are ensuring that medical device manufacturers produce and market safe products that comply the applicable regulation.Difference with CE technical file and 510k submission is need to provide clinical evaluation reports.To put together technical file design verification and validation is required where as for 510k onl6 design verification is needed.Another point of difference ,the CE technical file is required regardless of class of device in the EU whereas 510k is for classii or above in the U.S.