Medical and Regulatory Affairs

EU Medical Device Regulation: Your Questions Answered

With the European Union (EU)’s new Medical Device Regulation (MDR) taking effect in May 2020, device manufacturers transitioning to the EU MDR face a host of questions. Among them are:

  • Is it possible to avoid compliance with the MDR?
  • When should I be compliant?
  • How will this affect my new product development?
  • How does this affect my products currently on the market?
  • Which notified body should I use?
  • How will Brexit affect my company?
  • Where do I begin?

This webinar will address these and other critical questions and will pave the way to strategic planning for compliance with the EU MDR. New product development teams will discover that the timeline for MDR is extremely limited compared to existing products on the market. Post-market surveillance teams will discover the implications of the Post-Market Clinical Follow-up requirement and the European Database on Medical Devices.

In this webinar, our featured speakers will review the importance of: 

  • Having a robust regulatory strategy
  • Conducting a gap analysis of current technical documents and products
  • Investing in budgetary and human resources
  • Communicating with your Notified Body
  • Adopting to MDR within the allotted regulatory timelines