As a notified body, our company is designated for CE certification of medical devices.
CE conformity assessment of medical devices
According to the current legislation, a medical device may only be placed on the market in the European Union with the CE marking.
All products must meet the essential requirements that apply to them.
Depending on the classification of the product, it may be necessary to use a notified body, i.e. to carry out the CE conformity assessment with an external organization.
Information on conformity assessment procedure
The conformity assessment procedures of CE Certiso Kft. are shown on the following illustrations: