Regulatory compliance


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

We are in the process of updating all our products to meet the requirements for Medical Device Regulation (MDR, EU 2017/745).

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.

For addition information, consult our Quality Manager Eija Kutinlahti or Editor-in-Chief Johannes Lyytikkä.