Achieving EU Medical Device Regulation Compliance

Medical device companies must apply a coordinated approach to achieve compliance with the EU Medical Device Regulation (MDR). In a recent Life Science Leader article, learn key strategies for planning for MDR compliance. The first such strategy is the establishment of an effective leadership team that can synchronize activities company-wide.

According to Nach Davé, “Good leadership is essential for managing the transition to EU MDR compliance and creating an execution strategy which includes timelines and mechanisms for tracking progress on compliance activities. At a minimum, this leadership team should include representatives from Regulatory Affairs, Quality Assurance, Medical and/or Clinical Affairs, Marketing, Manufacturing, Biocompatibility, Sterilization, R&D, and Labeling. This leadership team must be actively engaged in communicating with the Notified Body, as well as establishing project harmonization amongst business units and product portfolios.”

To read more, click here.

(Source: Life Science Leader, November 29^th, 2022)