FREE ON-DEMAND WEBINAR

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.