By clicking “Accept All Cookies”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. View our Privacy Policy for more information.
PreferencesDenyAccept
Regulatory Affairs
Essential Insights for a Smooth Transition towards IVDR for In Vitro Diagnostic Manufacturers

As an In Vitro Diagnostic (IVD) manufacturer, it is crucial to stay informed about the latest regulatory requirements to ensure compliance and market access. The implementation of the In Vitro Diagnostic Regulation (IVDR) brings about significant changes, and navigating this transition successfully is paramount. In this blog post, we provide key takeaways to help you navigate the IVDR transition effectively.

Listen to article
By
Jack Purvis
Published on
July 12, 2023
Updated on
June 30, 2023
Table of Contents
  1. Adhere to Transition Deadlines: To avoid potential challenges and limited availability of Notified Bodies (NBs), it is essential to stay on track with the transition deadlines set by the European Commission. Start the transition process promptly to allow sufficient time for the necessary steps.
  1. Allocate Adequate Resources: The IVDR transition requires careful planning and allocation of resources. Ensure that your organisation has the necessary expertise, personnel, and documentation in place to meet the certification requirements within the specified timelines.
  1. Engage Proactively with Notified Bodies: Collaborating with NBs is a critical aspect of the certification process. Given the anticipated increase in demand as the deadlines approach, it is advisable to approach NBs early, submit required documentation promptly, and maintain open communication throughout the process.
  1. No Extension Anticipated: The European Commission and Competent Authorities have made it clear that there will not be another extension to the IVDR transition. Therefore, it is crucial to prioritise compliance and diligently work towards meeting the regulatory requirements within the given timeframe.
  1. Stay Informed about Re-classification: Ongoing discussions at the Commission/Competent Authorities level may lead to re-classification of certain IVD devices, including those related to SARS-CoV-2. Stay updated on these discussions and understand the potential implications for your products to ensure long-term regulatory compliance.

At PeploBio, we understand the complexities and challenges associated with the IVDR transition. Our dedicated team of regulatory experts is here to support you throughout the process, ensuring a smooth and successful transition. Visit our web page to learn more about our comprehensive regulatory affairs services and how we can help your organisation navigate the IVDR landscape with confidence.