In our August 2020 webinar you'll learn about the EU MDR and IVDR requirements for economic operators.
Get right to it → If you manufacture and market a device under your name or trademark, are an authorized representative, importer, or distributor of medical devices or in vitro diagnostic devices... this webinar is for you. The slides and webinar recording will be shared with registrants.
A little more detail...
Under the new regulations, the requirements for the economic operators change significantly. The party that manufactures and markets the devices will need to drive these changes. The other economic operators will need to understand the regulations and be able to verify regulatory requirements, manage complaints, and cooperate with the Notified Bodies and Competent Authorities. Communication, accessibility, and established processes are keys to success. With the right framework, all of the economic operators will be able to work together smoothly.
The Tuesday, August 25th webinar is for you if you want to understand more about the expectations and is geared for both medical device and in vitro diagnostic companies. If you are new to this concept, don’t worry, we will break down the concepts in an easy to follow way.
This webinar will discuss these topics and more:
- Why is this especially complicated for IVD companies?
- What are economic operators?
- What articles of the MDR/IVDR apply to the economic operators?
- What roles does each economic operator need to follow?
- What purchasing controls does the manufacturer need to have in place for economic operators?
- What are some of the things to include in mandates, quality agreements, or intracompany agreements with economic operators?
Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
Regulatory & Quality Solutions (R&Q)
Nancy has over 30 years of quality and regulatory experience in the medical industry with US and global regulatory submission experience. The previous seven 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 been providing EU MDR and IVDR leadership in developing solutions and implementing the regulations at small and large organizations.