Solving the EU MDR Labeling Puzzle

The EU MDR has enacted some of the most impactful changes in medical device regulation in the past decade. Key provisions within the new regulations specific to labeling present expanded requirements and initiatives towards greater transparency and traceability. The requirements for labeling aren’t relegated to a single section of the EU MDR, but are scattered throughout. This webinar will help you compile, understand, and learn how to act on those labeling requirements.

An intensive review of applicable regulations and processes for implementation and management will ensure a smooth transition for compliance.

Here’s some of what this webinar will cover and clarify with regard to the MDR requirements:
– Additional labeling content
– Symbology
– Translations
– Key EU UDI requirements
– Bundling multiple changes to minimize impact to operations
– Assessing the impact of label changes on your global registrations
– Brief but critical considerations related to economic operators and responsibilities
– Keys to compliance… in time for the deadline!

Presenters

Carol Vierling, RAC – Senior Principal Advisor, Regulatory & Quality Consulting Services
Regulatory & Quality Solutions (R&Q)

Carol has over 30 years of regulatory and clinical experience in the medical industry with US and global regulatory submission experience. The previous three years have been with R&Q working with start-up, mid-size and multi-national medical device companies. Carol has a Bachelor of Science in Nursing, a Masters in Business Administration and RAC certification. Carol has been a member of RAPS for more than 20 years. During that time, she has authored an article for RAPS Focus and was a member of the Board of Editors for five years where she has been a reviewer and topic leader.

Felicia Hosey, RAC – Senior Principal Specialist
Regulatory & Quality Solutions (R&Q)

Felicia is has worked in the medical device industry for over 15 years acting as a researcher on developmental projects, key product development and regulatory project team member and regulatory consultant to a wide variety of medical device and in vitro diagnostic medical device companies. Felicia is a member of RAPS with a global RAC, which has equipped her with the skills necessary to be successful on projects relating to domestic and international medical device regulations. She is also a member of the R&Q Leadership Council which is responsible for preparing reference tools and templates for use with multiple devices types during EU MDR and IVDR remediation.