- 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.
- 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.
- 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.
- 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.
- 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.