EU MDR for Combination Products

"Slides and presentation very informational about a topic that is somewhat confusing particularly as the guidelines and regulations change with the new MDR."

"I thought the presentation was informed, well-balanced, and professionally delivered - very much enjoyed it."

"Nancy is fabulous! Thank you for your time and useful insights."

"Speaker does a good job explaining topic on a relatable level."

"Very well run and the speaker was excellent. Looking forward to future webinars."

The rules have changed with Article 117 and more companies will require notified body involvement.

We will examine various device/drug combination products and determine how they are regulated under the EU MDR.

Under the EU MDR, this is the first time that devices that are integral with a drug product will require notified body assessment. Although the requirements are a subset of the full regulation, it will require compliance with the General Safety and Performance Requirements. We’ll also explore guidance that has been issued by European Medicines Agency on Article 117 and how they are interpreting what is an integral device with the medicinal substance. To wrap up we will explore the General Safety and Performance Requirements.

Presenter

Nancy Morrison, Director of Regulatory Affairs
Regulatory & Quality Solutions (R&Q)

Nancy has over 25 years of quality and regulatory experience in the medical industry with US and global regulatory submission experience. The previous five years have been with R&Q working with start-up, mid-size and multi-national medical device and combination product companies. Nancy has a Bachelor of Science in Mathematics and an Advanced Certificate in Regulatory Affairs along with RAC certifications for the US and EU. Nancy has the ability to build collaborative relationships with stakeholders to utilize regulations to identify opportunities that provide compliant and effective business solutions.