Recent EU Medical Device Regulatory Evolutions: Moving Forward

In June 2015, the EU Council published revisions to the 2012 EU medical devices and IVD regulatory proposals. Medical device manufacturers now await these updated regulations to understand key changes in conformity assessments and reclassifications. The June compromise documents help manufacturers better grasp their evolving regulatory requirements.

This webinar covers:

Reclassifications and regulatory scope expansions
Proposed conformity assessment changes
Next steps in the regulatory process