The revised MDD
93/42/EC (via 2007/47/EC) took effect in March 2010, marking the onset
of more rigorous regulations to which medical device manufacturers must
adhere while addressing competitive market pressures, emerging
technologies and higher patient expectations. Regulatory professionals
in this space are responsible for their companies’ compliance with
current regulations as well as developing and executing successful
business strategies around revisions that directly impact the bottom
line and their companies’ abilities to operate.