Ensuring uninterrupted sales of legacy EU IVDR devices
Self-certified devices up-classified to Class B
Reduction lead time
With the new EU In Vitro Diagnostics Regulation (EU IVDR) in place, it is imperative for IVD device manufacturers to comply with the new regulations to be able to sell their products in the EU region.
We helped a leading US-based diagnostic device manufacturer remediate their legacy self-certified devices as per the new EU IVDR. As the devices were up-classified under the new regulation, the remediation work involved a massive volume of documentation to ensure successful NB reviews and CE certification.
- Product understanding and assessment of the applicable requirements
- Gap assessment to understand the current state of the technical files
- Assessment of the existing raw/processed data, verification reports, and clinical data to check for data sufficiency
- Creation of customized SOPs, templates, and work instructions at the organization level as global procedures
- Project planning and management for execution of the project on anticipated timelines per customer requirements
- Compliance testing and document remediation as per the EU IVDR
- Technical file compilation and NB review comments redressal
Tata Elxsi facilitated a cross-functional team of engineers and regulatory affairs experts to understand the client's entire product portfolio, perform gap assessment and provide estimation for efforts and budgeting.
Our team established a communication channel with the client and their contract manufacturers to collate essential documents and data required for remediation work, especially for the up-classified devices. We also ensured the successful submission to the notified body and addressed the subsequent comments.
We successfully ensured uninterrupted sales of existing IVDs in the European market by receiving NB approval with minimal or no comments or observations.
Through optimized project planning and agile program management processes, we helped the client reduce lead time by 40%.
The Tata Elxsi team also facilitated a smooth IVDR transition and ensured there was no interruption in the client's regular R&D activities.