EU & FDA IVD Regulatory Compliance
Rely on TE Connectivity to guide your project from design and validation all the way through regulatory approval and manufacturing scale up.
IVD manufacturers often get into trouble when they don’t adequately understand FDA or EU requirements for technical documentation in support of regulatory submissions. This can result in clinical data that is inadequate to support a successful FDA submission or EU Notified Body review. TE offers expertise in clinical research, usability testing, and regulatory compliance specifically for IVD devices. This can streamline market clearances for your medical device and ultimately get your device to market faster. With numerous successful 510(k), CLIA, EUA, and CE marking submission clearances under our belt, TE's proven experience lowers your project risk and improves the odds of a successful outcome.
Core Competencies
- Full Contract Research Organization (CRO) Studies
- FDA 510(k), De Novo, and CLIA Waiver Requirements for IVD
- FDA 510(k) and Premarket Approvals (PMA)
- EU MDR and IVDR Regulation Technical Documentation Requirements
- EU Post-Market Clinical Follow-Up (PMCF) Studies
- Medical Device Risk Management
- ISO 14155 (Clinical Investigations of Medical Devices)
FDA Clearance and Approval
The path to FDA clearance is not always a straight line. In the 510(k) pathway, the FDA relies on the concept of “substantial equivalence.” Basically this means they compare your device to another already cleared for sale. But what happens when your technology is novel? TE's in-house clinical and regulatory experts evaluate your technology, its intended use, and existing cleared devices to recommend a cost-effective regulatory strategy. We perform clinical research and human factors engineering (HFE) to expedite your IVD device studies by providing study design and planning in addition to statistical analysis and electronic data management. Our proven methods can shorten the overall time between design and FDA approval by months.
CE Marking and EU IVDR Compliance
The EU’s migration from the In Vitro Medical Devices Directive to the new In Vitro Diagnostic Regulation (IVDR) has dramatically changed the requirements for IVD manufacturers. Beginning in May 2022, nearly 85% of new IVDs will require CE Marking certification. TE has extensive knowledge of the new IVDR, especially as they relate to the clinical data requirements needed to support CE Marking certification of Class B, C, and D devices. We will help you navigate the new IVDR quagmire and help ensure that your technical documentation is ready for your eventual CE Marking certification audit by a European Notified Body.
