The class IIa medical device SonoEyes by Incremed has received the CE label in May 2021, audited by the notified body TÜV Rheinland Italia. The CE mark states conformity with the essential requirements of the MDD, granting SonoEyes access to the european medical device market.
CE stands for Conformité Européenne. With the CE mark a manufacturer expresses conformity with the European legislation, specifically with European directives and European regulations.
In order to achieve the CE mark, Incremed built up a regulatory team, created an electronic QMS (Quality Management System), and collaborated with the notified body TÜV Rheinland Italia as well as a consulting company. To learn more about CE Marking, please click here.