For authorities

MDD/MDR

EBMEDS products currently meet the Class I requirements for medical devices (MDD)

We are in the process of updating all our products to meet Class IIa requirements for medical devices (MDR). This process will be completed by the end of 2019.

Declaration of conformity

The development, production and distribution of clinical decision support system (EBMEDS®) by Duodecim Medical Publications Ltd meets with the requirements in the EU Medical Device Directive. Compliance with the requirements will be declared with the CE Marking on the product, and supplying the service with a Declaration of Conformity. The Notified Body is The National Supervisory Authority for Welfare and Health (Valvira), Helsinki, Finland.

7.12.2018