Neuro Event Labs Receives European MDR Certification for Nelli® seizure detection and characterization device
Neuro Event Labs, the pioneer in AI motion diagnostics, is excited to announce it has completed the certification process under the European Union’s Medical Device Regulation (MDR) for its Nelli® as Class IIa device for seizure detection and characterization. This achievement makes Nelli the only seizure detection and epilepsy monitoring device to achieve MDR compliance and strengthens its position to provide epilepsy diagnostics and monitoring capabilities for healthcare professionals and industry both in hospital and at home environments.
An important characteristic of the MDR certification is a more rigorous and robust process for product clinical evaluation, including more stringent requirements for clinical evidence and data to demonstrate product safety and performance. In addition, a detailed and comprehensive approach to post-market surveillance ensures continued safety, functionality, and compatibility with the current state of the art. This is especially crucial for organizations who use Nelli in conducting clinical trials and seeking long-term, reliable, and future-proof solutions. Another key requirement of MDR is stricter enforcement of conformity with all relevant safety and performance standards, meticulously documented to ensure compliance.
“This is a major regulatory milestone for Neuro Event Labs on the international epilepsy stage,” said Kaapo Annala, founder and CEO of Neuro Event Labs. “As we continue to provide objective and accurate biomarkers and measures with advanced AI solutions for patients benefits, Nelli®’s MDR certification will reinforce the confidence of healthcare professionals and industry in implementing the most transformative new technology for patient care in epilepsy.
