"Well done! I was pleasantly surprised that you included all of the requirements of the plans and reports. You provided the information in digestible chunks."

"Nicely laid out to walk us through a very complicated set of requirements."

"Found it very informative and easy to understand. Being new to the world of regulatory that meant a lot."

"Thank you for your continued assistance to help clarify the MEDDEV Rev 4 requirements!  Great presentation!"

Excellent and concise presentation - THANK YOU!"

"I really liked how your company was transparent, which leads to your credibility. We don't know what all these regs mean in full detail."


Preparing your CER for MDR Compliance

The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market for a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices.

The time to plan and act on these changes is now.

The Clinical Evaluation Report (CER) is required under the regulations. Past practice of basing the device safety and performance on competitive or comparative devices with written justification for no post-market clinical follow-up may no longer satisfy the requirements. However, if you take the time during the transition period to gather clinical evidence on these devices, you will be prepared to meet these requirements.

This webinar will describe what to do now, what to keep your eye on, and real-world examples that show how industry is working through the changes. Interpretations will evolve, but R&Q experts will be able to help you navigate the process.

What's covered?

In addition to the background and history of EU MDR, the stacking effect for notified bodies, and R&Q's proposed solution, the session will cover the key EU MDR changes, including:

  • Required reports under the MDR related to clinical evidence
  • Frequency for report updates
  • Utilizing the Clinical Evaluation Plan as your roadmap
  • State of the Art Literature Searches
  • Types of clinical evidence
  • Reactive post-market surveillance
  • Proactive post-market surveillance
  • Leveraging real-world evidence
  • Navigating the changes with your notified body
  • What to do: R&Q recommended next steps

Key takeaways

  • Learn the essential EU MDR requirements for clinical evidence
  • Know how it might impact your company
  • Understand immediate actions and potential next steps
  • Practical tips and guidance for implementation
  • Valuable insight from experienced industry leaders

Who should view?

This session is designed for medical device manufacturers who market in the EU.

Also, newly appointed medical device companies in areas of cosmetics, cosmetic lights/lasers, colored contact lenses, cleaning and disinfecting solutions, and sub-dermal and trans-dermal implants are a good fit for this session.

Job functions include:

  • C-Level Executives
  • RA/QA Directors
  • Quality Managers
  • Regulatory Affairs Managers
  • Regulatory Specialists
  • Quality Specialists
  • Quality Engineers


About the presenter

Nancy Morrison, Director of Regulatory Affairs, 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.