How to Build an EU MDR Strategy for Regulatory Compliance

The EU Medical Device Regulation (EU MDR) became effective in May 2021. As a result, many medical device manufacturers may have questions as they adjust their regulatory compliance strategies, particularly for products marketed to in the European Union.

To help address these questions, Redica Systems hosted the virtual panel discussion webinar, “Changing Medical Device Regulations,” on Oct. 28. Panelists Mark Agostino, GMP Medical Device Expert, Redica Systems, and Alison Sathe, Founder, Regulatory Mark, answered questions submitted in advance and during the webinar. 

Redica Systems Senior GMP Quality Expert Jerry Chapman moderated. 

Recently, we published a four-part series of articles that included portions of the Q&A. These articles are valuable for anyone wishing to learn more about the EU MDR and to further refine their regulatory compliance strategy.

• The EU MDR and What it Means for Your QMS
  Find out what changes you need to make to your quality management system (QMS) in the wake of the EU MDR.
• The EU MDR and Postmarket Surveillance
  The EU MDR includes postmarket requirements. Learn how to meet these postmarket surveillance requirements.
• Global Harmonization of EU MDR Requirements
  Other countries’ regulatory agencies are looking to harmonize with the EU MDR. Discover which agencies are more inclined to harmonize.
• How Can Companies Train for EU MDR Changes?
  The panelists offer tips for training staff on EU MDR requirements. Plus, where to find further resources.

You can also view the panel discussion in its entirety by clicking here.