"Very enriching webinar. Thanks!!"

"Nice job today by the presenters."

"Thank you for this webinar. I would have liked to see an example of the EO chain, even for an imaginary medica device manufacturer."


The EU MDR extended the responsibilities of those who handle your information and product, and require you have new systems to interact with them throughout the process.

In this webinar we covered the requirements for authorized representatives, importers, and distributors. We also covered what you as the manufacturer need to do to ensure that these entities are prepared and ready for implementation.

Key webinar takeaways:

  • Your role as a manufacturer doesn’t end with just the release of finished goods. You will have to have document exchange in place.
  • Label approval is no longer just an internal process; your economic operators have responsibilities too.
  • You have to share not just product, but information – regular training and updates are required.
  • Authorized representatives have product liability under the EU MDR and if your authorized representative has been passive in the past about reviewing documents they probably won’t be in the future.
  • Options for managing push back or differences in opinion on complaints, technical documentation, and labeling between the manufacturer and economic operators.
  • How to create a quality agreement that defines and explains roles and responsibilities.
  • Authorized representatives need to have a person responsible for regulatory compliance.

Who should view?

This session is designed for regulatory, quality, and supply chain representatives.


Dean Miller, Senior Principal Engineer
Regulatory & Quality Solutions (R&Q)


Dean has 30+ years of industry experience and was part of the implementation of US Safe Medical Device Act (1987) and the first ISO 9000 Quality System Standards, US FDA Design Controls, Harmonized US Quality System Regulations, EU MDD, Canadian MDR, and EU MDR. His specialty is design and production quality assurance.



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

Nancy_Morrison_1-min-429968-edited.jpgNancy 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.