Competitiveness in EU medical device manufacturing

24.3.2014

Question for written answer E-003524-14
to the Commission
Rule 117
Diane Dodds (NI)

US medical device entrepreneurs who have relocated their businesses to Europe in search of a more favourable regulatory climate fear that an overhaul of EU rules will slow down approvals.

A series of US manufacturers of new medical devices have shifted to Europe, where more liberal regulations have allowed them to get quicker access to finance and markets for their products. In view of the possible tightening of these regulations, companies are now looking at options for relocating from Europe to countries such as China.

What is the current state of play in relation to stronger regulation, and what mechanisms are in place to keep Europe an attractive place for foreign investors to do business?

OJ C 343, 01/10/2014