With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance?
During this 45-minute Q&A session, our President Laurie Mitchell and Principal Medical Writer Dr. Sarah Chavez answered questions on the biggest pitfalls to look out for when writing a PER. In addition, they discuss how to align your internal processes and systems to comply with rigorous IVDR regulations and what technical documents are required for the PER, PEP, and PMPF.
Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Performance Evaluation Reports for EU IVDR submission.
Watch our recent webinar for more performance evaluation report guidance. We provide an overview of the State of the Art section, and explain how it fits into the overall process of writing a successful, IVDR-compliant PER. Additionally, we discuss the importance of readiness assessments and gap analyses. Then we help you identify critical resources, feeder documents, and expertise needed to consider your IVD “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.
Ultimately, the In Vitro Diagnostic Device Regulation 2017/746 is making sweeping changes to the EU regulatory requirements for IVD devices. Read our blog post for more on this topic. In it, we introduce some of the major requirements and list some of the important considerations for IVDR 2017/746 compliance.
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