Yes, Design Controls would be needed for a medical device in the EU. While there would be no DHF needed in the EU, most of the parts of design controls would still be needed, such as the: PDF, DDP, DID, etc. So almost all sections of the design controls are needed in the EU, but the full Design History File would not be compiled.

http://www.mastercontrol.com/newsletter/medical_device/medical-device-design-history-file-0710.html

-Andrew Nashed