The in-vitro diagnostic (IVD) device space has witnessed significant changes with the revised and more stringent European Union In-Vitro Diagnostic Device Regulation (EU IVDR). As the deadline approaches, there is an urgency to comprehend and implement sustainable solutions for EU IVDR compliance and beyond. Since the submissions for Notified Body (NB) evaluations have already begun, it is high time to examine the problems that manufacturers face during the remediation.
This whitepaper discusses the various challenges that manufacturers may come across during the EU IVDR transition journey and highlights the high-volume work and the critical nature of the activities involved in the remediation activities.
Read this whitepaper to understand:
The requirements for QMS under the new EU IVDR.
The unexpected challenges faced during the transition period and the possible solutions and best practices to overcome these challenges.
The real-life scenarios and examples that highlight the benefits of the presented solutions.