Best Tools & Tricks for Meeting IVDR Requirements to Obtain CE Marking

The European In Vitro Diagnostic Medical Device Regulation (IVDR) will go into effect in May 2022 and have profound impacts on the world’s second-largest medical device market.

IVDR introduces major changes to how manufacturers can obtain CE Marking and maintain access to the European market.

About 80% of companies have yet to make the transition to IVDR. Preparing for compliance with these new, more robust requirements presents significant challenges to manufacturers needing to  organize their regulatory transition strategies to achieve critical success factors, such as:

  • Technical Documentation of their devices, now for the first time ever, subject to Notified Body scrutiny
  • New, more detailed requirements on IVD performance evaluation documentation, including:
    • Performance Evaluation Plan (PEP)
    • Performance Evaluation Report (PER)
    • Supporting documentation on scientific validity, analytical performance, and clinical performance
  • Robust requirements in relation to Post-Market Surveillance (PMS), including Post-Market Performance Follow-up (PMPF)

We've teamed up with EMERGO by UL to share their expertise on IVDR and provenly effective ways for IVD manufacturers to make a smooth transition in meeting all compliance requirements.

Watch the webinar

Emergo webinar - 10-8-20
Specifically, this webinar will cover:
  • Key aspects about what manufacturers can expect from these new regulations
  • How to prepare Technical Documentation
  • Best practices for IVDR compliance and Notified Body review
  • Proven tools and resources proven to streamline transition to IVDR
  • Q&A Session
Who Should Attend?
  • In Vitro Diagnostic Device Executives
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • R&D Engineers and Management
  • Clinical Affairs Professionals and Management
Register Now  

Hosted by

Presenter: Michael Dun

Senior Consultant, EMERGO by UL

Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru


About Emergo by UL
EMERGO by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success. With a presence on six continents, we can provide real-time service and on-the-ground expertise. Learn more about how we can help you grow. Visit our website to learn more.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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