NightWatch+ is the world’s first epileptic seizure alarm to receive MDR class IIa certification under the EU MDR, setting a new standard in seizure detection technology.

NightWatch is a clinically validated medical device designed to monitor epileptic seizures during sleep and alert caregivers, enabling them to provide medical assistance if needed. 

With the European Medical Device Regulation (MDR, EU 2017/745) now in full effect, all medical device manufacturers must comply with significantly stricter requirements than the previous Medical Device Directive (MDD). The MDR certification process demands rigorous clinical evaluation, increased transparency, and robust evidence of safety and performance all of which aim to enhancing patient care and ensuring accountability in the EU medical device market.

Validated by Over 15 Years of Clinical Research

NightWatch+ has successfully met these stringent MDR standards by leveraging over 15 years of collaborative research from leading epilepsy centers SEIN, Kempenhaeghe, and UMC Utrecht, along with multiple long-term prospective trials conducted among both children and adults in diverse living environments. The extensive data confirms that NightWatch effectively detects the most dangerous nocturnal seizures, significantly reducing the stress of caregivers.

Setting a New Benchmark for the Industry

“We brought NightWatch to the market with a clear mission: to improve the lives of people with epilepsy,” said Jeroen van den Hout, CEO of NightWatch. “Over the past years, we’ve made a tremendous impact on thousands of families who live with the constant fear of missing a dangerous nighttime seizure. Every night.”

“The hundreds of independent online reviews affirm that we are on the right path. With the launch of NightWatch+, we take our mission even further. Not only does it provide our trusted seizure alarm technology, but it also enables users to track long-term seizure activity via the NightWatch Data Platform. This platform will serve as a foundation for future research, helping us work toward better, more personalized epilepsy care, treatment, and even seizure prediction.”

The MDR class IIa certification of NightWatch+ sets a new standard for seizure alarms. This milestone underscores the importance of compliant, validated medical solutions in the field of epilepsy care, paving the way forward to drive meaningful innovation and improve patient outcomes.

NightWatch+ is available across Europe and the UK. 

Visit https://nightwatchepilepsy.com/nightwatch/ for more information.