As more and more companies are drawing out of the EU because of EU MDR complications, choosing to remain in in a less crowded market could provide competitive advantage.
Leeanne Baker, Managing Director and Senior QA/RA Consultant at IMed Consultancy analyses the benefits of remaining on the EU market despite difficulties, delays and costs connected to achieving EU MDR compliance.
With more than eight in ten companies saying the time it takes to secure permits is a barrier to investing in Europe, and 53% of companies calling it “a serious problem”, it is not surprising to hear that many medical device manufacturers are opting to pull out of Europe.
In what therefore looks set to be a much less crowded post EU MDR market, medical device manufacturers willing to dedicate time and resources to comply with the new regulation might find they have gained key competitive advantage.
Leeanne looks at strategies to help smooth the transition to EU MDR and be first in line for these rich pickings.