Strategic Planning For Compliance With The EU Medical Device Regulation

By Nach Davé

Compliance with the EU Medical Devices Regulation (MDR) is a significant undertaking that requires cross-functional collaboration. In this post, we explore key activities involved in strategic planning for compliance.

Establishing a leadership team

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.

Read the about the remaining activities in this blog.